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SSRResearchStudy

SSRResearchStudy (ResearchStudy)	I		ResearchStudy	There are no (further) constraints on this element Element id ResearchStudy Short description Investigation to increase healthcare-related patient-independent knowledge Alternate names Clinical Trial, Study Definition A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques. A ResearchStudy involves the gathering of information about human or animal subjects. Comments Need to make sure we encompass public health studies. Data type ResearchStudy Constraints dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources `contained.contained.empty()` dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource `contained.where((('#'+id in (%resource.descendants().reference \| %resource.descendants().as(canonical) \| %resource.descendants().as(uri) \| %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()` dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated `contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()` dom-5: If a resource is contained in another resource, it SHALL NOT have a security label `contained.meta.security.empty()` dom-6: A resource should have narrative for robust management text.`div`.exists() Mappings rim: Entity. Role, or Act BRIDG5.1: ObservationalStudyProtocolVersion; Study; StudyProtocolVersion v2: OBX rim: Observation[classCode=CLNTRL, moodCode=EVN]
id	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.id Short description Logical id of this artifact Definition The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. Comments The only time that a resource does not have an id is when it is being submitted to the server using a create operation. Data type string
meta	Σ	0..1	Meta	There are no (further) constraints on this element Element id ResearchStudy.meta Short description Metadata about the resource Definition The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource. Data type Meta Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
implicitRules	Σ ?!	0..1	uri	There are no (further) constraints on this element Element id ResearchStudy.implicitRules Short description A set of rules under which this content was created Definition A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc. Comments Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
language		0..1	codeBinding	There are no (further) constraints on this element Element id ResearchStudy.language Short description Language of the resource content Definition The base language in which the resource is written. Comments Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute). Data type code Binding A human language. CommonLanguages (preferred) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
text		0..1	Narrative	There are no (further) constraints on this element Element id ResearchStudy.text Short description Text summary of the resource, for human interpretation Alternate names narrative, html, xhtml, display Definition A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety. Comments Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later. Data type Narrative Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: Act.text?
contained		0..*	Resource	There are no (further) constraints on this element Element id ResearchStudy.contained Short description Contained, inline Resources Alternate names inline resources, anonymous resources, contained resources Definition These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope. Comments This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels. Data type Resource Mappings rim: N/A
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
modifierExtension	?! I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.modifierExtension Short description Extensions that cannot be ignored Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
identifier	Σ	0..*	Identifier	There are no (further) constraints on this element Element id ResearchStudy.identifier Short description Business Identifier for study Definition Identifiers assigned to this research study by the sponsor or other systems. Requirements Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers. Data type Identifier Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Organization's Unique Protocol ID; Secondary IDs w5: FiveWs.identifier BRIDG5.1: No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic) rim: .identifier
title	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.title Short description Name for this study Definition A short, descriptive user-friendly label for the study. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Brief Title BRIDG5.1: No BRIDG mapping (although there is StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)
protocol	Σ	0..*	Reference(PlanDefinition)	There are no (further) constraints on this element Element id ResearchStudy.protocol Short description Steps followed in executing study Definition The set of steps expected to be performed as part of the execution of the study. Data type Reference(PlanDefinition) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Interventions; Arm/Intervention Cross-Reference BRIDG5.1: StudyProtocolDocumentVersionPublicTitle.name rim: .outboundRelationship[typeCode=DEFN].target
partOf	Σ	0..*	Reference(ResearchStudy)	There are no (further) constraints on this element Element id ResearchStudy.partOf Short description Part of larger study Alternate names container Definition A larger research study of which this particular study is a component or step. Requirements Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc. Data type Reference(ResearchStudy) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings BRIDG5.1: CompanionStudyRelationship rim: .inboundRelationship[typeCode=COMP].source[moodCode=EVN]
status	Σ ?!	1..1	codeBindingFixed Value	Element id ResearchStudy.status Short description active \| administratively-completed \| approved \| closed-to-accrual \| closed-to-accrual-and-intervention \| completed \| disapproved \| in-review \| temporarily-closed-to-accrual \| temporarily-closed-to-accrual-and-intervention \| withdrawn Definition The current state of the study. Data type code Binding Codes that convey the current status of the research study. ResearchStudyStatus (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Fixed value active Mappings w5: FiveWs.status BRIDG5.1: StudyOverallStatus.code rim: .status
primaryPurposeType	Σ	0..1	CodeableConceptBinding	There are no (further) constraints on this element Element id ResearchStudy.primaryPurposeType Short description treatment \| prevention \| diagnostic \| supportive-care \| screening \| health-services-research \| basic-science \| device-feasibility Definition The type of study based upon the intent of the study's activities. A classification of the intent of the study. Data type CodeableConcept Binding Codes for the main intent of the study. ResearchStudyPrimaryPurposeType (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings BRIDG5.1: StudyProtocolVersion.primaryPurposeTypeCode
phase	Σ	0..1	CodeableConcept	There are no (further) constraints on this element Element id ResearchStudy.phase Short description n-a \| early-phase-1 \| phase-1 \| phase-1-phase-2 \| phase-2 \| phase-2-phase-3 \| phase-3 \| phase-4 Definition The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation. Data type CodeableConcept Binding Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation. ResearchStudyPhase (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Study Phase BRIDG5.1: StudyProtocolVersion.phaseCode
category	Σ	0..*	CodeableConcept	There are no (further) constraints on this element Element id ResearchStudy.category Short description Classifications for the study Definition Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc. Data type CodeableConcept Binding Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc. (unbound) (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention BRIDG5.1: InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode
focus	Σ	0..*	CodeableConcept	There are no (further) constraints on this element Element id ResearchStudy.focus Short description Drugs, devices, etc. under study Definition The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about. Data type CodeableConcept Binding Codes for medications, devices and other interventions. (unbound) (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Focus of Study w5: FiveWs.what[x] BRIDG5.1: InterventionalStudyProtocol.interventionTypeCode
condition	Σ	1..*	CodeableConceptBinding	Element id ResearchStudy.condition Short description Condition being studied Definition The condition that is the focus of the study. For example, In a study to examine risk factors for Lupus, might have as an inclusion criterion "healthy volunteer", but the target condition code would be a Lupus SNOMED code. Data type CodeableConcept Binding The name of an FRB Audit Group. ssr-research-studies (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Conditions w5: FiveWs.what[x] BRIDG5.1: StudyCondition.code
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.condition.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.condition.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
coding	Σ	1..*	Coding	There are no (further) constraints on this element Element id ResearchStudy.condition.coding Short description Code defined by a terminology system Definition A reference to a code defined by a terminology system. Requirements Allows for alternative encodings within a code system, and translations to other code systems. Comments Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.condition.coding.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.condition.coding.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
system	Σ	0..1	uri	There are no (further) constraints on this element Element id ResearchStudy.condition.coding.system Short description Identity of the terminology system Definition The identification of the code system that defines the meaning of the symbol in the code. Requirements Need to be unambiguous about the source of the definition of the symbol. Comments The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.3 rim:* ./codeSystem orim: fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
version	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.condition.coding.version Short description Version of the system - if relevant Definition The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged. Comments Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.7 rim:* ./codeSystemVersion orim: fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
code	Σ	1..1	code	There are no (further) constraints on this element Element id ResearchStudy.condition.coding.code Short description Symbol in syntax defined by the system Definition A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination). Requirements Need to refer to a particular code in the system. Data type code Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1 rim:* ./code orim: fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
display	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.condition.coding.display Short description Representation defined by the system Definition A representation of the meaning of the code in the system, following the rules of the system. Requirements Need to be able to carry a human-readable meaning of the code for readers that do not know the system. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.2 - but note this is not well followed rim:* CV.displayName orim: fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
userSelected	Σ	0..1	boolean	There are no (further) constraints on this element Element id ResearchStudy.condition.coding.userSelected Short description If this coding was chosen directly by the user Definition Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays). Requirements This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing. Comments Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely. Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: Sometimes implied by being first rim: CD.codingRationale orim: fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
text	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.condition.text Short description Plain text representation of the concept Definition A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. Requirements The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Comments Very often the text is the same as a displayName of one of the codings. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
contact	Σ	0..*	ContactDetail	There are no (further) constraints on this element Element id ResearchStudy.contact Short description Contact details for the study Definition Contact details to assist a user in learning more about or engaging with the study. Data type ContactDetail Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators BRIDG5.1: PointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVersion
relatedArtifact		0..*	RelatedArtifact	There are no (further) constraints on this element Element id ResearchStudy.relatedArtifact Short description References and dependencies Definition Citations, references and other related documents. Data type RelatedArtifact Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Citations, Links, Available Study Data/Documents BRIDG5.1: StudyProtocolDocument, StudyProtocolDocumentVersion
keyword	Σ	0..*	CodeableConcept	There are no (further) constraints on this element Element id ResearchStudy.keyword Short description Used to search for the study Definition Key terms to aid in searching for or filtering the study. Data type CodeableConcept Binding Words associated with the study that may be useful in discovery. (unbound) (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Keywords BRIDG5.1: DocumentVersion.keywordCode; DocumentVersion.keywordText
location	Σ	0..*	CodeableConceptBinding	There are no (further) constraints on this element Element id ResearchStudy.location Short description Geographic region(s) for study Definition Indicates a country, state or other region where the study is taking place. Data type CodeableConcept Binding Countries and regions within which this artifact is targeted for use. Jurisdiction ValueSet (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings BRIDG5.1: StudyProtocolVersion.participatingLocationCode
description		0..1	markdown	There are no (further) constraints on this element Element id ResearchStudy.description Short description What this is study doing Definition A full description of how the study is being conducted. Data type markdown Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Detailed Description BRIDG5.1: StudyProtocolDocumentVersion.publicDescription
enrollment	Σ	0..*	Reference(Group)	There are no (further) constraints on this element Element id ResearchStudy.enrollment Short description Inclusion & exclusion criteria Alternate names patient Definition Reference to a Group that defines the criteria for and quantity of subjects participating in the study. E.g. " 200 female Europeans between the ages of 20 and 45 with early onset diabetes". Comments The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource. Data type Reference(Group) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Enrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria) w5: FiveWs.subject[x] BRIDG5.1: InterventionalStudyProtocol.interventionGroupQuantity rim: .participation[typeCode=SBJ].role w5: FiveWs.subject
period	Σ	0..1	Period	There are no (further) constraints on this element Element id ResearchStudy.period Short description When the study began and ended Alternate names timing Definition Identifies the start date and the expected (or actual, depending on status) end date for the study. Data type Period Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Study Start Date (start); Study Completion Date (end) w5: FiveWs.done[x] BRIDG5.1: ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration rim: .effectiveTime
sponsor	Σ	0..1	Reference(Organization)	There are no (further) constraints on this element Element id ResearchStudy.sponsor Short description Organization that initiates and is legally responsible for the study Definition An organization that initiates the investigation and is legally responsible for the study. Data type Reference(Organization) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Sponsor w5: FiveWs.actor BRIDG5.1: RegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode rim: .participation[typeCode=PRF].role[scoper.determinerCode=INSTANCE]
principalInvestigator	Σ	0..1	Reference(Practitioner \| PractitionerRole)	There are no (further) constraints on this element Element id ResearchStudy.principalInvestigator Short description Researcher who oversees multiple aspects of the study Definition A researcher in a study who oversees multiple aspects of the study, such as concept development, protocol writing, protocol submission for IRB approval, participant recruitment, informed consent, data collection, analysis, interpretation and presentation. Data type Reference(Practitioner \| PractitionerRole) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Principal Investigator w5: FiveWs.actor BRIDG5.1: StudyInvestigator
site	Σ	0..*	Reference(Location)	There are no (further) constraints on this element Element id ResearchStudy.site Short description Facility where study activities are conducted Definition A facility in which study activities are conducted. Data type Reference(Location) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Facility w5: FiveWs.where[x] BRIDG5.1: PlannedStudySite; StudySite
reasonStopped	Σ	0..1	CodeableConcept	There are no (further) constraints on this element Element id ResearchStudy.reasonStopped Short description accrual-goal-met \| closed-due-to-toxicity \| closed-due-to-lack-of-study-progress \| temporarily-closed-per-study-design Definition A description and/or code explaining the premature termination of the study. Data type CodeableConcept Binding Codes for why the study ended prematurely. ResearchStudyReasonStopped (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Why Study Stopped w5: FiveWs.why[x] BRIDG5.1: StudyOverallStatus.studyStoppedReasonCode
note		0..*	Annotation	There are no (further) constraints on this element Element id ResearchStudy.note Short description Comments made about the study Definition Comments made about the study by the performer, subject or other participants. Data type Annotation Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings BRIDG5.1: No BRIDG mapping rim: .inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]
arm		0..*	BackboneElement	There are no (further) constraints on this element Element id ResearchStudy.arm Short description Defined path through the study for a subject Definition Describes an expected sequence of events for one of the participants of a study. E.g. Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Arms BRIDG5.1: Arm
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.arm.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.arm.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.arm.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
name		1..1	string	There are no (further) constraints on this element Element id ResearchStudy.arm.name Short description Label for study arm Definition Unique, human-readable label for this arm of the study. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Arm Label BRIDG5.1: Arm.name
type		0..1	CodeableConcept	There are no (further) constraints on this element Element id ResearchStudy.arm.type Short description Categorization of study arm Definition Categorization of study arm, e.g. experimental, active comparator, placebo comparater. Data type CodeableConcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Arm Type BRIDG5.1: Arm.typeCode
description		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.arm.description Short description Short explanation of study path Definition A succinct description of the path through the study that would be followed by a subject adhering to this arm. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings clinicaltrials-gov: Arm Description BRIDG5.1: Arm.description
objective		0..*	BackboneElement	There are no (further) constraints on this element Element id ResearchStudy.objective Short description A goal for the study Definition A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings BRIDG5.1: StudyObjective
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.objective.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.objective.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.objective.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
name		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.objective.name Short description Label for the objective Definition Unique, human-readable label for this objective of the study. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings BRIDG5.1: No BRIDG mapping (BRIDG has a description, but not a name)
type		0..1	CodeableConceptBinding	There are no (further) constraints on this element Element id ResearchStudy.objective.type Short description primary \| secondary \| exploratory Definition The kind of study objective. Data type CodeableConcept Binding Codes for the kind of study objective. ResearchStudyObjectiveType (preferred) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings BRIDG5.1: StudyObjective.typeCode

{
    "resourceType": "StructureDefinition",
    "url": "https://frbresearch.org/fhir/StructureDefinition/SSRResearchStudy",
    "name": "SSRResearchStudy",
    "status": "draft",
    "description": "An FRB audit group identifying the focus of a study which a patient is involved in.",
    "fhirVersion": "4.0.1",
    "kind": "resource",
    "abstract": false,
    "type": "ResearchStudy",
    "baseDefinition": "http://hl7.org/fhir/StructureDefinition/ResearchStudy",
    "derivation": "constraint",
    "snapshot": {
        "element":  [
            {
                "id": "ResearchStudy",
                "path": "ResearchStudy",
                "short": "Investigation to increase healthcare-related patient-independent knowledge",
                "definition": "A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge.  This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques.  A ResearchStudy involves the gathering of information about human or animal subjects.",
                "comment": "Need to make sure we encompass public health studies.",
                "alias":  [
                    "Clinical Trial",
                    "Study"
                ],
                "min": 0,
                "max": "*",
                "base": {
                    "path": "ResearchStudy",
                    "min": 0,
                    "max": "*"
                },
                "constraint":  [
                    {
                        "key": "dom-2",
                        "severity": "error",
                        "human": "If the resource is contained in another resource, it SHALL NOT contain nested Resources",
                        "expression": "contained.contained.empty()",
                        "xpath": "not(parent::f:contained and f:contained)",
                        "source": "http://hl7.org/fhir/StructureDefinition/DomainResource"
                    },
                    {
                        "key": "dom-4",
                        "severity": "error",
                        "human": "If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated",
                        "expression": "contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()",
                        "xpath": "not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))",
                        "source": "http://hl7.org/fhir/StructureDefinition/DomainResource"
                    },
                    {
                        "key": "dom-3",
                        "severity": "error",
                        "human": "If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource",
                        "expression": "contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()",
                        "xpath": "not(exists(for $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))",
                        "source": "http://hl7.org/fhir/StructureDefinition/DomainResource"
                    },
                    {
                        "extension":  [
                            {
                                "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice",
                                "valueBoolean": true
                            },
                            {
                                "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation",
                                "valueMarkdown": "When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time."
                            }
                        ],
                        "key": "dom-6",
                        "severity": "warning",
                        "human": "A resource should have narrative for robust management",
                        "expression": "text.`div`.exists()",
                        "xpath": "exists(f:text/h:div)",
                        "source": "http://hl7.org/fhir/StructureDefinition/DomainResource"
                    },
                    {
                        "key": "dom-5",
                        "severity": "error",
                        "human": "If a resource is contained in another resource, it SHALL NOT have a security label",
                        "expression": "contained.meta.security.empty()",
                        "xpath": "not(exists(f:contained/*/f:meta/f:security))",
                        "source": "http://hl7.org/fhir/StructureDefinition/DomainResource"
                    }
                ],
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "Entity. Role, or Act"
                    },
                    {
                        "identity": "BRIDG5.1",
                        "map": "ObservationalStudyProtocolVersion; Study;\nStudyProtocolVersion"
                    },
                    {
                        "identity": "v2",
                        "map": "OBX"
                    },
                    {
                        "identity": "rim",
                        "map": "Observation[classCode=CLNTRL, moodCode=EVN]"
                    }
                ]
            },
            {
                "id": "ResearchStudy.id",
                "path": "ResearchStudy.id",
                "short": "Logical id of this artifact",
                "definition": "The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.",
                "comment": "The only time that a resource does not have an id is when it is being submitted to the server using a create operation.",
                "min": 0,
                "max": "1",
                "base": {
                    "path": "Resource.id",
                    "min": 0,
                    "max": "1"
                },
                "type":  [
                    {
                        "extension":  [
                            {
                                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                                "valueUrl": "string"
                            }
                        ],
                        "code": "http://hl7.org/fhirpath/System.String"
                    }
                ],
                "isSummary": true
            },
            {
                "id": "ResearchStudy.meta",
                "extension":  [
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
                        "valueCode": "normative"
                    },
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
                        "valueCode": "4.0.0"
                    }
                ],
                "path": "ResearchStudy.meta",
                "short": "Metadata about the resource",
                "definition": "The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.",
                "min": 0,
                "max": "1",
                "base": {
                    "path": "Resource.meta",
                    "min": 0,
                    "max": "1"
                },
                "type":  [
                    {
                        "code": "Meta"
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    }
                ],
                "isSummary": true,
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "rim",
                        "map": "N/A"
                    }
                ]
            },
            {
                "id": "ResearchStudy.implicitRules",
                "path": "ResearchStudy.implicitRules",
                "short": "A set of rules under which this content was created",
                "definition": "A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.",
                "comment": "Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.",
                "min": 0,
                "max": "1",
                "base": {
                    "path": "Resource.implicitRules",
                    "min": 0,
                    "max": "1"
                },
                "type":  [
                    {
                        "code": "uri"
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    }
                ],
                "isModifier": true,
                "isModifierReason": "This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation",
                "isSummary": true,
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    }
                ]
            },
            {
                "id": "ResearchStudy.language",
                "path": "ResearchStudy.language",
                "short": "Language of the resource content",
                "definition": "The base language in which the resource is written.",
                "comment": "Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies  to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).",
                "min": 0,
                "max": "1",
                "base": {
                    "path": "Resource.language",
                    "min": 0,
                    "max": "1"
                },
                "type":  [
                    {
                        "code": "code"
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    }
                ],
                "binding": {
                    "extension":  [
                        {
                            "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet",
                            "valueCanonical": "http://hl7.org/fhir/ValueSet/all-languages"
                        },
                        {
                            "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
                            "valueString": "Language"
                        },
                        {
                            "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
                            "valueBoolean": true
                        }
                    ],
                    "strength": "preferred",
                    "description": "A human language.",
                    "valueSet": "http://hl7.org/fhir/ValueSet/languages"
                },
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    }
                ]
            },
            {
                "id": "ResearchStudy.text",
                "extension":  [
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
                        "valueCode": "normative"
                    },
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
                        "valueCode": "4.0.0"
                    }
                ],
                "path": "ResearchStudy.text",
                "short": "Text summary of the resource, for human interpretation",
                "definition": "A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.",
                "comment": "Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied).  This may be necessary for data from legacy systems where information is captured as a \"text blob\" or where text is additionally entered raw or narrated and encoded information is added later.",
                "alias":  [
                    "narrative",
                    "html",
                    "xhtml",
                    "display"
                ],
                "min": 0,
                "max": "1",
                "base": {
                    "path": "DomainResource.text",
                    "min": 0,
                    "max": "1"
                },
                "type":  [
                    {
                        "code": "Narrative"
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    }
                ],
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "rim",
                        "map": "N/A"
                    },
                    {
                        "identity": "rim",
                        "map": "Act.text?"
                    }
                ]
            },
            {
                "id": "ResearchStudy.contained",
                "path": "ResearchStudy.contained",
                "short": "Contained, inline Resources",
                "definition": "These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.",
                "comment": "This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.",
                "alias":  [
                    "inline resources",
                    "anonymous resources",
                    "contained resources"
                ],
                "min": 0,
                "max": "*",
                "base": {
                    "path": "DomainResource.contained",
                    "min": 0,
                    "max": "*"
                },
                "type":  [
                    {
                        "code": "Resource"
                    }
                ],
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "Entity. Role, or Act"
                    },
                    {
                        "identity": "rim",
                        "map": "N/A"
                    }
                ]
            },
            {
                "id": "ResearchStudy.extension",
                "extension":  [
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
                        "valueCode": "normative"
                    },
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
                        "valueCode": "4.0.0"
                    }
                ],
                "path": "ResearchStudy.extension",
                "slicing": {
                    "discriminator":  [
                        {
                            "type": "value",
                            "path": "url"
                        }
                    ],
                    "description": "Extensions are always sliced by (at least) url",
                    "rules": "open"
                },
                "short": "Additional content defined by implementations",
                "definition": "May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
                "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
                "alias":  [
                    "extensions",
                    "user content"
                ],
                "min": 0,
                "max": "*",
                "base": {
                    "path": "DomainResource.extension",
                    "min": 0,
                    "max": "*"
                },
                "type":  [
                    {
                        "code": "Extension"
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    },
                    {
                        "key": "ext-1",
                        "severity": "error",
                        "human": "Must have either extensions or value[x], not both",
                        "expression": "extension.exists() != value.exists()",
                        "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
                        "source": "http://hl7.org/fhir/StructureDefinition/Extension"
                    }
                ],
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "rim",
                        "map": "N/A"
                    }
                ]
            },
            {
                "id": "ResearchStudy.modifierExtension",
                "extension":  [
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
                        "valueCode": "normative"
                    },
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
                        "valueCode": "4.0.0"
                    }
                ],
                "path": "ResearchStudy.modifierExtension",
                "slicing": {
                    "discriminator":  [
                        {
                            "type": "value",
                            "path": "url"
                        }
                    ],
                    "description": "Extensions are always sliced by (at least) url",
                    "rules": "open"
                },
                "short": "Extensions that cannot be ignored",
                "definition": "May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
                "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
                "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
                "alias":  [
                    "extensions",
                    "user content"
                ],
                "min": 0,
                "max": "*",
                "base": {
                    "path": "DomainResource.modifierExtension",
                    "min": 0,
                    "max": "*"
                },
                "type":  [
                    {
                        "code": "Extension"
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    },
                    {
                        "key": "ext-1",
                        "severity": "error",
                        "human": "Must have either extensions or value[x], not both",
                        "expression": "extension.exists() != value.exists()",
                        "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
                        "source": "http://hl7.org/fhir/StructureDefinition/Extension"
                    }
                ],
                "isModifier": true,
                "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them",
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "rim",
                        "map": "N/A"
                    }
                ]
            },
            {
                "id": "ResearchStudy.identifier",
                "extension":  [
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
                        "valueCode": "normative"
                    },
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
                        "valueCode": "4.0.0"
                    }
                ],
                "path": "ResearchStudy.identifier",
                "short": "Business Identifier for study",
                "definition": "Identifiers assigned to this research study by the sponsor or other systems.",
                "requirements": "Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.",
                "min": 0,
                "max": "*",
                "base": {
                    "path": "ResearchStudy.identifier",
                    "min": 0,
                    "max": "*"
                },
                "type":  [
                    {
                        "code": "Identifier"
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    }
                ],
                "isSummary": true,
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "v2",
                        "map": "CX / EI (occasionally, more often EI maps to a resource id or a URL)"
                    },
                    {
                        "identity": "rim",
                        "map": "II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs.  Also maps to Role[classCode=IDENT]"
                    },
                    {
                        "identity": "servd",
                        "map": "Identifier"
                    },
                    {
                        "identity": "clinicaltrials-gov",
                        "map": "Organization's Unique Protocol ID; Secondary IDs"
                    },
                    {
                        "identity": "w5",
                        "map": "FiveWs.identifier"
                    },
                    {
                        "identity": "BRIDG5.1",
                        "map": "No BRIDG mapping (although there is  DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)"
                    },
                    {
                        "identity": "rim",
                        "map": ".identifier"
                    }
                ]
            },
            {
                "id": "ResearchStudy.title",
                "path": "ResearchStudy.title",
                "short": "Name for this study",
                "definition": "A short, descriptive user-friendly label for the study.",
                "comment": "Note that FHIR strings SHALL NOT exceed 1MB in size",
                "min": 0,
                "max": "1",
                "base": {
                    "path": "ResearchStudy.title",
                    "min": 0,
                    "max": "1"
                },
                "type":  [
                    {
                        "code": "string"
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    }
                ],
                "isSummary": true,
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "clinicaltrials-gov",
                        "map": "Brief Title"
                    },
                    {
                        "identity": "BRIDG5.1",
                        "map": "No BRIDG mapping (although there is  StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)"
                    }
                ]
            },
            {
                "id": "ResearchStudy.protocol",
                "extension":  [
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
                        "valueCode": "normative"
                    },
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
                        "valueCode": "4.0.0"
                    }
                ],
                "path": "ResearchStudy.protocol",
                "short": "Steps followed in executing study",
                "definition": "The set of steps expected to be performed as part of the execution of the study.",
                "comment": "References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.",
                "min": 0,
                "max": "*",
                "base": {
                    "path": "ResearchStudy.protocol",
                    "min": 0,
                    "max": "*"
                },
                "type":  [
                    {
                        "code": "Reference",
                        "targetProfile":  [
                            "http://hl7.org/fhir/StructureDefinition/PlanDefinition"
                        ]
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    },
                    {
                        "key": "ref-1",
                        "severity": "error",
                        "human": "SHALL have a contained resource if a local reference is provided",
                        "expression": "reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))",
                        "xpath": "not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])",
                        "source": "http://hl7.org/fhir/StructureDefinition/Reference"
                    }
                ],
                "isSummary": true,
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "rim",
                        "map": "The target of a resource reference is a RIM entry point (Act, Role, or Entity)"
                    },
                    {
                        "identity": "clinicaltrials-gov",
                        "map": "Interventions; Arm/Intervention Cross-Reference"
                    },
                    {
                        "identity": "BRIDG5.1",
                        "map": "StudyProtocolDocumentVersionPublicTitle.name"
                    },
                    {
                        "identity": "rim",
                        "map": ".outboundRelationship[typeCode=DEFN].target"
                    }
                ]
            },
            {
                "id": "ResearchStudy.partOf",
                "extension":  [
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
                        "valueCode": "normative"
                    },
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
                        "valueCode": "4.0.0"
                    }
                ],
                "path": "ResearchStudy.partOf",
                "short": "Part of larger study",
                "definition": "A larger research study of which this particular study is a component or step.",
                "comment": "References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.",
                "requirements": "Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc.",
                "alias":  [
                    "container"
                ],
                "min": 0,
                "max": "*",
                "base": {
                    "path": "ResearchStudy.partOf",
                    "min": 0,
                    "max": "*"
                },
                "type":  [
                    {
                        "code": "Reference",
                        "targetProfile":  [
                            "http://hl7.org/fhir/StructureDefinition/ResearchStudy"
                        ]
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    },
                    {
                        "key": "ref-1",
                        "severity": "error",
                        "human": "SHALL have a contained resource if a local reference is provided",
                        "expression": "reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))",
                        "xpath": "not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])",
                        "source": "http://hl7.org/fhir/StructureDefinition/Reference"
                    }
                ],
                "isSummary": true,
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "rim",
                        "map": "The target of a resource reference is a RIM entry point (Act, Role, or Entity)"
                    },
                    {
                        "identity": "BRIDG5.1",
                        "map": "CompanionStudyRelationship"
                    },
                    {
                        "identity": "rim",
                        "map": ".inboundRelationship[typeCode=COMP].source[moodCode=EVN]"
                    }
                ]
            },
            {
                "id": "ResearchStudy.status",
                "path": "ResearchStudy.status",
                "short": "active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn",
                "definition": "The current state of the study.",
                "comment": "Note that FHIR strings SHALL NOT exceed 1MB in size",
                "min": 1,
                "max": "1",
                "base": {
                    "path": "ResearchStudy.status",
                    "min": 1,
                    "max": "1"
                },
                "type":  [
                    {
                        "code": "code"
                    }
                ],
                "fixedCode": "active",
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    }
                ],
                "isModifier": true,
                "isModifierReason": "This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid",
                "isSummary": true,
                "binding": {
                    "extension":  [
                        {
                            "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
                            "valueString": "ResearchStudyStatus"
                        }
                    ],
                    "strength": "required",
                    "description": "Codes that convey the current status of the research study.",
                    "valueSet": "http://hl7.org/fhir/ValueSet/research-study-status|4.0.1"
                },
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "w5",
                        "map": "FiveWs.status"
                    },
                    {
                        "identity": "BRIDG5.1",
                        "map": "StudyOverallStatus.code"
                    },
                    {
                        "identity": "rim",
                        "map": ".status"
                    }
                ]
            },
            {
                "id": "ResearchStudy.primaryPurposeType",
                "extension":  [
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
                        "valueCode": "normative"
                    },
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
                        "valueCode": "4.0.0"
                    }
                ],
                "path": "ResearchStudy.primaryPurposeType",
                "short": "treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility",
                "definition": "The type of study based upon the intent of the study's activities. A classification of the intent of the study.",
                "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.",
                "min": 0,
                "max": "1",
                "base": {
                    "path": "ResearchStudy.primaryPurposeType",
                    "min": 0,
                    "max": "1"
                },
                "type":  [
                    {
                        "code": "CodeableConcept"
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    }
                ],
                "isSummary": true,
                "binding": {
                    "extension":  [
                        {
                            "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
                            "valueString": "ResearchStudyPrimaryPurposeType"
                        }
                    ],
                    "strength": "extensible",
                    "description": "Codes for the main intent of the study.",
                    "valueSet": "http://hl7.org/fhir/ValueSet/research-study-prim-purp-type"
                },
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "v2",
                        "map": "CE/CNE/CWE"
                    },
                    {
                        "identity": "rim",
                        "map": "CD"
                    },
                    {
                        "identity": "orim",
                        "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD"
                    },
                    {
                        "identity": "BRIDG5.1",
                        "map": "StudyProtocolVersion.primaryPurposeTypeCode"
                    }
                ]
            },
            {
                "id": "ResearchStudy.phase",
                "extension":  [
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
                        "valueCode": "normative"
                    },
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
                        "valueCode": "4.0.0"
                    }
                ],
                "path": "ResearchStudy.phase",
                "short": "n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4",
                "definition": "The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.",
                "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.",
                "min": 0,
                "max": "1",
                "base": {
                    "path": "ResearchStudy.phase",
                    "min": 0,
                    "max": "1"
                },
                "type":  [
                    {
                        "code": "CodeableConcept"
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    }
                ],
                "isSummary": true,
                "binding": {
                    "extension":  [
                        {
                            "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
                            "valueString": "ResearchStudyPhase"
                        }
                    ],
                    "strength": "example",
                    "description": "Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.",
                    "valueSet": "http://hl7.org/fhir/ValueSet/research-study-phase"
                },
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "v2",
                        "map": "CE/CNE/CWE"
                    },
                    {
                        "identity": "rim",
                        "map": "CD"
                    },
                    {
                        "identity": "orim",
                        "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD"
                    },
                    {
                        "identity": "clinicaltrials-gov",
                        "map": "Study Phase"
                    },
                    {
                        "identity": "BRIDG5.1",
                        "map": "StudyProtocolVersion.phaseCode"
                    }
                ]
            },
            {
                "id": "ResearchStudy.category",
                "extension":  [
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
                        "valueCode": "normative"
                    },
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
                        "valueCode": "4.0.0"
                    }
                ],
                "path": "ResearchStudy.category",
                "short": "Classifications for the study",
                "definition": "Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.",
                "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.",
                "min": 0,
                "max": "*",
                "base": {
                    "path": "ResearchStudy.category",
                    "min": 0,
                    "max": "*"
                },
                "type":  [
                    {
                        "code": "CodeableConcept"
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    }
                ],
                "isSummary": true,
                "binding": {
                    "extension":  [
                        {
                            "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
                            "valueString": "ResearchStudyCategory"
                        }
                    ],
                    "strength": "example",
                    "description": "Codes that describe the type of research study.  E.g. Study phase, Interventional/Observational, blinding type, etc."
                },
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "v2",
                        "map": "CE/CNE/CWE"
                    },
                    {
                        "identity": "rim",
                        "map": "CD"
                    },
                    {
                        "identity": "orim",
                        "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD"
                    },
                    {
                        "identity": "clinicaltrials-gov",
                        "map": "Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention"
                    },
                    {
                        "identity": "BRIDG5.1",
                        "map": "InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode"
                    }
                ]
            },
            {
                "id": "ResearchStudy.focus",
                "extension":  [
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
                        "valueCode": "normative"
                    },
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
                        "valueCode": "4.0.0"
                    }
                ],
                "path": "ResearchStudy.focus",
                "short": "Drugs, devices, etc. under study",
                "definition": "The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about.",
                "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.",
                "min": 0,
                "max": "*",
                "base": {
                    "path": "ResearchStudy.focus",
                    "min": 0,
                    "max": "*"
                },
                "type":  [
                    {
                        "code": "CodeableConcept"
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    }
                ],
                "isSummary": true,
                "binding": {
                    "extension":  [
                        {
                            "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
                            "valueString": "ResearchStudyFocus"
                        }
                    ],
                    "strength": "example",
                    "description": "Codes for medications, devices and other interventions."
                },
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "v2",
                        "map": "CE/CNE/CWE"
                    },
                    {
                        "identity": "rim",
                        "map": "CD"
                    },
                    {
                        "identity": "orim",
                        "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD"
                    },
                    {
                        "identity": "clinicaltrials-gov",
                        "map": "Focus of Study"
                    },
                    {
                        "identity": "w5",
                        "map": "FiveWs.what[x]"
                    },
                    {
                        "identity": "BRIDG5.1",
                        "map": "InterventionalStudyProtocol.interventionTypeCode"
                    }
                ]
            },
            {
                "id": "ResearchStudy.condition",
                "extension":  [
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
                        "valueCode": "normative"
                    },
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
                        "valueCode": "4.0.0"
                    }
                ],
                "path": "ResearchStudy.condition",
                "short": "Condition being studied",
                "definition": "The condition that is the focus of the study.  For example, In a study to examine risk factors for Lupus, might have as an inclusion criterion \"healthy volunteer\", but the target condition code would be a Lupus SNOMED code.",
                "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.",
                "min": 1,
                "max": "*",
                "base": {
                    "path": "ResearchStudy.condition",
                    "min": 0,
                    "max": "*"
                },
                "type":  [
                    {
                        "code": "CodeableConcept"
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    }
                ],
                "isSummary": true,
                "binding": {
                    "extension":  [
                        {
                            "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
                            "valueString": "ConditionCode"
                        }
                    ],
                    "strength": "required",
                    "description": "The name of an FRB Audit Group.",
                    "valueSet": "https://frbresearch.org/fhir/ValueSet/ssr-research-studies"
                },
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "v2",
                        "map": "CE/CNE/CWE"
                    },
                    {
                        "identity": "rim",
                        "map": "CD"
                    },
                    {
                        "identity": "orim",
                        "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD"
                    },
                    {
                        "identity": "clinicaltrials-gov",
                        "map": "Conditions"
                    },
                    {
                        "identity": "w5",
                        "map": "FiveWs.what[x]"
                    },
                    {
                        "identity": "BRIDG5.1",
                        "map": "StudyCondition.code"
                    }
                ]
            },
            {
                "id": "ResearchStudy.condition.id",
                "path": "ResearchStudy.condition.id",
                "representation":  [
                    "xmlAttr"
                ],
                "short": "Unique id for inter-element referencing",
                "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
                "min": 0,
                "max": "1",
                "base": {
                    "path": "Element.id",
                    "min": 0,
                    "max": "1"
                },
                "type":  [
                    {
                        "extension":  [
                            {
                                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                                "valueUrl": "string"
                            }
                        ],
                        "code": "http://hl7.org/fhirpath/System.String"
                    }
                ],
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    }
                ]
            },
            {
                "id": "ResearchStudy.condition.extension",
                "extension":  [
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
                        "valueCode": "normative"
                    },
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
                        "valueCode": "4.0.0"
                    }
                ],
                "path": "ResearchStudy.condition.extension",
                "slicing": {
                    "discriminator":  [
                        {
                            "type": "value",
                            "path": "url"
                        }
                    ],
                    "description": "Extensions are always sliced by (at least) url",
                    "rules": "open"
                },
                "short": "Additional content defined by implementations",
                "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
                "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
                "alias":  [
                    "extensions",
                    "user content"
                ],
                "min": 0,
                "max": "*",
                "base": {
                    "path": "Element.extension",
                    "min": 0,
                    "max": "*"
                },
                "type":  [
                    {
                        "code": "Extension"
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    },
                    {
                        "key": "ext-1",
                        "severity": "error",
                        "human": "Must have either extensions or value[x], not both",
                        "expression": "extension.exists() != value.exists()",
                        "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
                        "source": "http://hl7.org/fhir/StructureDefinition/Extension"
                    }
                ],
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "rim",
                        "map": "N/A"
                    }
                ]
            },
            {
                "id": "ResearchStudy.condition.coding",
                "extension":  [
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
                        "valueCode": "normative"
                    },
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
                        "valueCode": "4.0.0"
                    }
                ],
                "path": "ResearchStudy.condition.coding",
                "short": "Code defined by a terminology system",
                "definition": "A reference to a code defined by a terminology system.",
                "comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
                "requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
                "min": 1,
                "max": "*",
                "base": {
                    "path": "CodeableConcept.coding",
                    "min": 0,
                    "max": "*"
                },
                "type":  [
                    {
                        "code": "Coding"
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    }
                ],
                "isSummary": true,
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "v2",
                        "map": "CE/CNE/CWE subset one of the sets of component 1-3 or 4-6"
                    },
                    {
                        "identity": "rim",
                        "map": "CV"
                    },
                    {
                        "identity": "orim",
                        "map": "fhir:Coding rdfs:subClassOf dt:CDCoding"
                    },
                    {
                        "identity": "v2",
                        "map": "C*E.1-8, C*E.10-22"
                    },
                    {
                        "identity": "rim",
                        "map": "union(., ./translation)"
                    },
                    {
                        "identity": "orim",
                        "map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"
                    }
                ]
            },
            {
                "id": "ResearchStudy.condition.coding.id",
                "path": "ResearchStudy.condition.coding.id",
                "representation":  [
                    "xmlAttr"
                ],
                "short": "Unique id for inter-element referencing",
                "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
                "min": 0,
                "max": "1",
                "base": {
                    "path": "Element.id",
                    "min": 0,
                    "max": "1"
                },
                "type":  [
                    {
                        "extension":  [
                            {
                                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                                "valueUrl": "string"
                            }
                        ],
                        "code": "http://hl7.org/fhirpath/System.String"
                    }
                ],
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    }
                ]
            },
            {
                "id": "ResearchStudy.condition.coding.extension",
                "extension":  [
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
                        "valueCode": "normative"
                    },
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
                        "valueCode": "4.0.0"
                    }
                ],
                "path": "ResearchStudy.condition.coding.extension",
                "slicing": {
                    "discriminator":  [
                        {
                            "type": "value",
                            "path": "url"
                        }
                    ],
                    "description": "Extensions are always sliced by (at least) url",
                    "rules": "open"
                },
                "short": "Additional content defined by implementations",
                "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
                "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
                "alias":  [
                    "extensions",
                    "user content"
                ],
                "min": 0,
                "max": "*",
                "base": {
                    "path": "Element.extension",
                    "min": 0,
                    "max": "*"
                },
                "type":  [
                    {
                        "code": "Extension"
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    },
                    {
                        "key": "ext-1",
                        "severity": "error",
                        "human": "Must have either extensions or value[x], not both",
                        "expression": "extension.exists() != value.exists()",
                        "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
                        "source": "http://hl7.org/fhir/StructureDefinition/Extension"
                    }
                ],
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "rim",
                        "map": "N/A"
                    }
                ]
            },
            {
                "id": "ResearchStudy.condition.coding.system",
                "path": "ResearchStudy.condition.coding.system",
                "short": "Identity of the terminology system",
                "definition": "The identification of the code system that defines the meaning of the symbol in the code.",
                "comment": "The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...).  OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.",
                "requirements": "Need to be unambiguous about the source of the definition of the symbol.",
                "min": 0,
                "max": "1",
                "base": {
                    "path": "Coding.system",
                    "min": 0,
                    "max": "1"
                },
                "type":  [
                    {
                        "code": "uri"
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    }
                ],
                "isSummary": true,
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "v2",
                        "map": "C*E.3"
                    },
                    {
                        "identity": "rim",
                        "map": "./codeSystem"
                    },
                    {
                        "identity": "orim",
                        "map": "fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem"
                    }
                ]
            },
            {
                "id": "ResearchStudy.condition.coding.version",
                "path": "ResearchStudy.condition.coding.version",
                "short": "Version of the system - if relevant",
                "definition": "The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.",
                "comment": "Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.",
                "min": 0,
                "max": "1",
                "base": {
                    "path": "Coding.version",
                    "min": 0,
                    "max": "1"
                },
                "type":  [
                    {
                        "code": "string"
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    }
                ],
                "isSummary": true,
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "v2",
                        "map": "C*E.7"
                    },
                    {
                        "identity": "rim",
                        "map": "./codeSystemVersion"
                    },
                    {
                        "identity": "orim",
                        "map": "fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion"
                    }
                ]
            },
            {
                "id": "ResearchStudy.condition.coding.code",
                "path": "ResearchStudy.condition.coding.code",
                "short": "Symbol in syntax defined by the system",
                "definition": "A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).",
                "comment": "Note that FHIR strings SHALL NOT exceed 1MB in size",
                "requirements": "Need to refer to a particular code in the system.",
                "min": 1,
                "max": "1",
                "base": {
                    "path": "Coding.code",
                    "min": 0,
                    "max": "1"
                },
                "type":  [
                    {
                        "code": "code"
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    }
                ],
                "isSummary": true,
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "v2",
                        "map": "C*E.1"
                    },
                    {
                        "identity": "rim",
                        "map": "./code"
                    },
                    {
                        "identity": "orim",
                        "map": "fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code"
                    }
                ]
            },
            {
                "id": "ResearchStudy.condition.coding.display",
                "extension":  [
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
                        "valueBoolean": true
                    }
                ],
                "path": "ResearchStudy.condition.coding.display",
                "short": "Representation defined by the system",
                "definition": "A representation of the meaning of the code in the system, following the rules of the system.",
                "comment": "Note that FHIR strings SHALL NOT exceed 1MB in size",
                "requirements": "Need to be able to carry a human-readable meaning of the code for readers that do not know  the system.",
                "min": 0,
                "max": "1",
                "base": {
                    "path": "Coding.display",
                    "min": 0,
                    "max": "1"
                },
                "type":  [
                    {
                        "code": "string"
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    }
                ],
                "isSummary": true,
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "v2",
                        "map": "C*E.2 - but note this is not well followed"
                    },
                    {
                        "identity": "rim",
                        "map": "CV.displayName"
                    },
                    {
                        "identity": "orim",
                        "map": "fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName"
                    }
                ]
            },
            {
                "id": "ResearchStudy.condition.coding.userSelected",
                "path": "ResearchStudy.condition.coding.userSelected",
                "short": "If this coding was chosen directly by the user",
                "definition": "Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).",
                "comment": "Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.",
                "requirements": "This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.",
                "min": 0,
                "max": "1",
                "base": {
                    "path": "Coding.userSelected",
                    "min": 0,
                    "max": "1"
                },
                "type":  [
                    {
                        "code": "boolean"
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    }
                ],
                "isSummary": true,
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "v2",
                        "map": "Sometimes implied by being first"
                    },
                    {
                        "identity": "rim",
                        "map": "CD.codingRationale"
                    },
                    {
                        "identity": "orim",
                        "map": "fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map;   fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\\#true a [     fhir:source \"true\";     fhir:target dt:CDCoding.codingRationale\\#O   ]"
                    }
                ]
            },
            {
                "id": "ResearchStudy.condition.text",
                "extension":  [
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
                        "valueBoolean": true
                    }
                ],
                "path": "ResearchStudy.condition.text",
                "short": "Plain text representation of the concept",
                "definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
                "comment": "Very often the text is the same as a displayName of one of the codings.",
                "requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
                "min": 0,
                "max": "1",
                "base": {
                    "path": "CodeableConcept.text",
                    "min": 0,
                    "max": "1"
                },
                "type":  [
                    {
                        "code": "string"
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    }
                ],
                "isSummary": true,
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "v2",
                        "map": "C*E.9. But note many systems use C*E.2 for this"
                    },
                    {
                        "identity": "rim",
                        "map": "./originalText[mediaType/code=\"text/plain\"]/data"
                    },
                    {
                        "identity": "orim",
                        "map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"
                    }
                ]
            },
            {
                "id": "ResearchStudy.contact",
                "extension":  [
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
                        "valueCode": "normative"
                    },
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
                        "valueCode": "4.0.0"
                    }
                ],
                "path": "ResearchStudy.contact",
                "short": "Contact details for the study",
                "definition": "Contact details to assist a user in learning more about or engaging with the study.",
                "min": 0,
                "max": "*",
                "base": {
                    "path": "ResearchStudy.contact",
                    "min": 0,
                    "max": "*"
                },
                "type":  [
                    {
                        "code": "ContactDetail"
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    }
                ],
                "isSummary": true,
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "clinicaltrials-gov",
                        "map": "Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators"
                    },
                    {
                        "identity": "BRIDG5.1",
                        "map": "PointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVersion"
                    }
                ]
            },
            {
                "id": "ResearchStudy.relatedArtifact",
                "extension":  [
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
                        "valueCode": "trial-use"
                    },
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
                        "valueCode": "4.0.0"
                    }
                ],
                "path": "ResearchStudy.relatedArtifact",
                "short": "References and dependencies",
                "definition": "Citations, references and other related documents.",
                "comment": "Each related artifact is either an attachment, or a reference to another knowledge resource, but not both.",
                "min": 0,
                "max": "*",
                "base": {
                    "path": "ResearchStudy.relatedArtifact",
                    "min": 0,
                    "max": "*"
                },
                "type":  [
                    {
                        "code": "RelatedArtifact"
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    }
                ],
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "clinicaltrials-gov",
                        "map": "Citations, Links, Available Study Data/Documents"
                    },
                    {
                        "identity": "BRIDG5.1",
                        "map": "StudyProtocolDocument, StudyProtocolDocumentVersion"
                    }
                ]
            },
            {
                "id": "ResearchStudy.keyword",
                "extension":  [
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
                        "valueCode": "normative"
                    },
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
                        "valueCode": "4.0.0"
                    }
                ],
                "path": "ResearchStudy.keyword",
                "short": "Used to search for the study",
                "definition": "Key terms to aid in searching for or filtering the study.",
                "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.",
                "min": 0,
                "max": "*",
                "base": {
                    "path": "ResearchStudy.keyword",
                    "min": 0,
                    "max": "*"
                },
                "type":  [
                    {
                        "code": "CodeableConcept"
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    }
                ],
                "isSummary": true,
                "binding": {
                    "extension":  [
                        {
                            "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
                            "valueString": "ResearchStudyKeyword"
                        }
                    ],
                    "strength": "example",
                    "description": "Words associated with the study that may be useful in discovery."
                },
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "v2",
                        "map": "CE/CNE/CWE"
                    },
                    {
                        "identity": "rim",
                        "map": "CD"
                    },
                    {
                        "identity": "orim",
                        "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD"
                    },
                    {
                        "identity": "clinicaltrials-gov",
                        "map": "Keywords"
                    },
                    {
                        "identity": "BRIDG5.1",
                        "map": "DocumentVersion.keywordCode; DocumentVersion.keywordText"
                    }
                ]
            },
            {
                "id": "ResearchStudy.location",
                "extension":  [
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
                        "valueCode": "normative"
                    },
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
                        "valueCode": "4.0.0"
                    }
                ],
                "path": "ResearchStudy.location",
                "short": "Geographic region(s) for study",
                "definition": "Indicates a country, state or other region where the study is taking place.",
                "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.",
                "min": 0,
                "max": "*",
                "base": {
                    "path": "ResearchStudy.location",
                    "min": 0,
                    "max": "*"
                },
                "type":  [
                    {
                        "code": "CodeableConcept"
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    }
                ],
                "isSummary": true,
                "binding": {
                    "extension":  [
                        {
                            "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
                            "valueString": "Jurisdiction"
                        },
                        {
                            "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
                            "valueBoolean": true
                        }
                    ],
                    "strength": "extensible",
                    "description": "Countries and regions within which this artifact is targeted for use.",
                    "valueSet": "http://hl7.org/fhir/ValueSet/jurisdiction"
                },
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "v2",
                        "map": "CE/CNE/CWE"
                    },
                    {
                        "identity": "rim",
                        "map": "CD"
                    },
                    {
                        "identity": "orim",
                        "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD"
                    },
                    {
                        "identity": "BRIDG5.1",
                        "map": "StudyProtocolVersion.participatingLocationCode"
                    }
                ]
            },
            {
                "id": "ResearchStudy.description",
                "path": "ResearchStudy.description",
                "short": "What this is study doing",
                "definition": "A full description of how the study is being conducted.",
                "comment": "Systems are not required to have markdown support, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/",
                "min": 0,
                "max": "1",
                "base": {
                    "path": "ResearchStudy.description",
                    "min": 0,
                    "max": "1"
                },
                "type":  [
                    {
                        "code": "markdown"
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    }
                ],
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "clinicaltrials-gov",
                        "map": "Detailed Description"
                    },
                    {
                        "identity": "BRIDG5.1",
                        "map": "StudyProtocolDocumentVersion.publicDescription"
                    }
                ]
            },
            {
                "id": "ResearchStudy.enrollment",
                "extension":  [
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
                        "valueCode": "normative"
                    },
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
                        "valueCode": "4.0.0"
                    }
                ],
                "path": "ResearchStudy.enrollment",
                "short": "Inclusion & exclusion criteria",
                "definition": "Reference to a Group that defines the criteria for and quantity of subjects participating in the study.  E.g. \" 200 female Europeans between the ages of 20 and 45 with early onset diabetes\".",
                "comment": "The Group referenced should not generally enumerate specific subjects.  Subjects will be linked to the study using the ResearchSubject resource.",
                "alias":  [
                    "patient"
                ],
                "min": 0,
                "max": "*",
                "base": {
                    "path": "ResearchStudy.enrollment",
                    "min": 0,
                    "max": "*"
                },
                "type":  [
                    {
                        "code": "Reference",
                        "targetProfile":  [
                            "http://hl7.org/fhir/StructureDefinition/Group"
                        ]
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    },
                    {
                        "key": "ref-1",
                        "severity": "error",
                        "human": "SHALL have a contained resource if a local reference is provided",
                        "expression": "reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))",
                        "xpath": "not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])",
                        "source": "http://hl7.org/fhir/StructureDefinition/Reference"
                    }
                ],
                "isSummary": true,
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "rim",
                        "map": "The target of a resource reference is a RIM entry point (Act, Role, or Entity)"
                    },
                    {
                        "identity": "clinicaltrials-gov",
                        "map": "Enrollment; Number of Groups/Cohorts (= number of \"enrollment\" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)"
                    },
                    {
                        "identity": "w5",
                        "map": "FiveWs.subject[x]"
                    },
                    {
                        "identity": "BRIDG5.1",
                        "map": "InterventionalStudyProtocol.interventionGroupQuantity"
                    },
                    {
                        "identity": "rim",
                        "map": ".participation[typeCode=SBJ].role"
                    },
                    {
                        "identity": "w5",
                        "map": "FiveWs.subject"
                    }
                ]
            },
            {
                "id": "ResearchStudy.period",
                "extension":  [
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
                        "valueCode": "normative"
                    },
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
                        "valueCode": "4.0.0"
                    }
                ],
                "path": "ResearchStudy.period",
                "short": "When the study began and ended",
                "definition": "Identifies the start date and the expected (or actual, depending on status) end date for the study.",
                "comment": "A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. \"the patient was an inpatient of the hospital for this time range\") or one value from the range applies (e.g. \"give to the patient between these two times\").\n\nPeriod is not used for a duration (a measure of elapsed time). See [Duration](datatypes.html#Duration).",
                "alias":  [
                    "timing"
                ],
                "min": 0,
                "max": "1",
                "base": {
                    "path": "ResearchStudy.period",
                    "min": 0,
                    "max": "1"
                },
                "type":  [
                    {
                        "code": "Period"
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    },
                    {
                        "key": "per-1",
                        "severity": "error",
                        "human": "If present, start SHALL have a lower value than end",
                        "expression": "start.hasValue().not() or end.hasValue().not() or (start <= end)",
                        "xpath": "not(exists(f:start/@value)) or not(exists(f:end/@value)) or (xs:dateTime(f:start/@value) <= xs:dateTime(f:end/@value))",
                        "source": "http://hl7.org/fhir/StructureDefinition/Period"
                    }
                ],
                "isSummary": true,
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "v2",
                        "map": "DR"
                    },
                    {
                        "identity": "rim",
                        "map": "IVL<TS>[lowClosed=\"true\" and highClosed=\"true\"] or URG<TS>[lowClosed=\"true\" and highClosed=\"true\"]"
                    },
                    {
                        "identity": "clinicaltrials-gov",
                        "map": "Study Start Date (start); Study Completion Date (end)"
                    },
                    {
                        "identity": "w5",
                        "map": "FiveWs.done[x]"
                    },
                    {
                        "identity": "BRIDG5.1",
                        "map": "ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration"
                    },
                    {
                        "identity": "rim",
                        "map": ".effectiveTime"
                    }
                ]
            },
            {
                "id": "ResearchStudy.sponsor",
                "extension":  [
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
                        "valueCode": "normative"
                    },
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
                        "valueCode": "4.0.0"
                    }
                ],
                "path": "ResearchStudy.sponsor",
                "short": "Organization that initiates and is legally responsible for the study",
                "definition": "An organization that initiates the investigation and is legally responsible for the study.",
                "comment": "References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.",
                "min": 0,
                "max": "1",
                "base": {
                    "path": "ResearchStudy.sponsor",
                    "min": 0,
                    "max": "1"
                },
                "type":  [
                    {
                        "code": "Reference",
                        "targetProfile":  [
                            "http://hl7.org/fhir/StructureDefinition/Organization"
                        ]
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    },
                    {
                        "key": "ref-1",
                        "severity": "error",
                        "human": "SHALL have a contained resource if a local reference is provided",
                        "expression": "reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))",
                        "xpath": "not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])",
                        "source": "http://hl7.org/fhir/StructureDefinition/Reference"
                    }
                ],
                "isSummary": true,
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "rim",
                        "map": "The target of a resource reference is a RIM entry point (Act, Role, or Entity)"
                    },
                    {
                        "identity": "clinicaltrials-gov",
                        "map": "Sponsor"
                    },
                    {
                        "identity": "w5",
                        "map": "FiveWs.actor"
                    },
                    {
                        "identity": "BRIDG5.1",
                        "map": "RegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode"
                    },
                    {
                        "identity": "rim",
                        "map": ".participation[typeCode=PRF].role[scoper.determinerCode=INSTANCE]"
                    }
                ]
            },
            {
                "id": "ResearchStudy.principalInvestigator",
                "extension":  [
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
                        "valueCode": "normative"
                    },
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
                        "valueCode": "4.0.0"
                    }
                ],
                "path": "ResearchStudy.principalInvestigator",
                "short": "Researcher who oversees multiple aspects of the study",
                "definition": "A researcher in a study who oversees multiple aspects of the study, such as concept development, protocol writing, protocol submission for IRB approval, participant recruitment, informed consent, data collection, analysis, interpretation and presentation.",
                "comment": "References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.",
                "min": 0,
                "max": "1",
                "base": {
                    "path": "ResearchStudy.principalInvestigator",
                    "min": 0,
                    "max": "1"
                },
                "type":  [
                    {
                        "code": "Reference",
                        "targetProfile":  [
                            "http://hl7.org/fhir/StructureDefinition/Practitioner",
                            "http://hl7.org/fhir/StructureDefinition/PractitionerRole"
                        ]
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    },
                    {
                        "key": "ref-1",
                        "severity": "error",
                        "human": "SHALL have a contained resource if a local reference is provided",
                        "expression": "reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))",
                        "xpath": "not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])",
                        "source": "http://hl7.org/fhir/StructureDefinition/Reference"
                    }
                ],
                "isSummary": true,
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "rim",
                        "map": "The target of a resource reference is a RIM entry point (Act, Role, or Entity)"
                    },
                    {
                        "identity": "clinicaltrials-gov",
                        "map": "Principal Investigator"
                    },
                    {
                        "identity": "w5",
                        "map": "FiveWs.actor"
                    },
                    {
                        "identity": "BRIDG5.1",
                        "map": "StudyInvestigator"
                    }
                ]
            },
            {
                "id": "ResearchStudy.site",
                "extension":  [
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
                        "valueCode": "normative"
                    },
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
                        "valueCode": "4.0.0"
                    }
                ],
                "path": "ResearchStudy.site",
                "short": "Facility where study activities are conducted",
                "definition": "A facility in which study activities are conducted.",
                "comment": "References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.",
                "min": 0,
                "max": "*",
                "base": {
                    "path": "ResearchStudy.site",
                    "min": 0,
                    "max": "*"
                },
                "type":  [
                    {
                        "code": "Reference",
                        "targetProfile":  [
                            "http://hl7.org/fhir/StructureDefinition/Location"
                        ]
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    },
                    {
                        "key": "ref-1",
                        "severity": "error",
                        "human": "SHALL have a contained resource if a local reference is provided",
                        "expression": "reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))",
                        "xpath": "not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])",
                        "source": "http://hl7.org/fhir/StructureDefinition/Reference"
                    }
                ],
                "isSummary": true,
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "rim",
                        "map": "The target of a resource reference is a RIM entry point (Act, Role, or Entity)"
                    },
                    {
                        "identity": "clinicaltrials-gov",
                        "map": "Facility"
                    },
                    {
                        "identity": "w5",
                        "map": "FiveWs.where[x]"
                    },
                    {
                        "identity": "BRIDG5.1",
                        "map": "PlannedStudySite; StudySite"
                    }
                ]
            },
            {
                "id": "ResearchStudy.reasonStopped",
                "extension":  [
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
                        "valueCode": "normative"
                    },
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
                        "valueCode": "4.0.0"
                    }
                ],
                "path": "ResearchStudy.reasonStopped",
                "short": "accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design",
                "definition": "A description and/or code explaining the premature termination of the study.",
                "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.",
                "min": 0,
                "max": "1",
                "base": {
                    "path": "ResearchStudy.reasonStopped",
                    "min": 0,
                    "max": "1"
                },
                "type":  [
                    {
                        "code": "CodeableConcept"
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    }
                ],
                "isSummary": true,
                "binding": {
                    "extension":  [
                        {
                            "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
                            "valueString": "ResearchStudyReasonStopped"
                        }
                    ],
                    "strength": "example",
                    "description": "Codes for why the study ended prematurely.",
                    "valueSet": "http://hl7.org/fhir/ValueSet/research-study-reason-stopped"
                },
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "v2",
                        "map": "CE/CNE/CWE"
                    },
                    {
                        "identity": "rim",
                        "map": "CD"
                    },
                    {
                        "identity": "orim",
                        "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD"
                    },
                    {
                        "identity": "clinicaltrials-gov",
                        "map": "Why Study Stopped"
                    },
                    {
                        "identity": "w5",
                        "map": "FiveWs.why[x]"
                    },
                    {
                        "identity": "BRIDG5.1",
                        "map": "StudyOverallStatus.studyStoppedReasonCode"
                    }
                ]
            },
            {
                "id": "ResearchStudy.note",
                "extension":  [
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
                        "valueCode": "normative"
                    },
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
                        "valueCode": "4.0.0"
                    }
                ],
                "path": "ResearchStudy.note",
                "short": "Comments made about the study",
                "definition": "Comments made about the study by the performer, subject or other participants.",
                "comment": "For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time.  This element may need to be included in narrative because of the potential for modifying information.  *Annotations SHOULD NOT* be used to communicate \"modifying\" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible).",
                "min": 0,
                "max": "*",
                "base": {
                    "path": "ResearchStudy.note",
                    "min": 0,
                    "max": "*"
                },
                "type":  [
                    {
                        "code": "Annotation"
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    }
                ],
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "v2",
                        "map": "N/A"
                    },
                    {
                        "identity": "rim",
                        "map": "Act"
                    },
                    {
                        "identity": "BRIDG5.1",
                        "map": "No BRIDG mapping"
                    },
                    {
                        "identity": "rim",
                        "map": ".inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]"
                    }
                ]
            },
            {
                "id": "ResearchStudy.arm",
                "extension":  [
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
                        "valueCode": "normative"
                    },
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
                        "valueCode": "4.0.0"
                    }
                ],
                "path": "ResearchStudy.arm",
                "short": "Defined path through the study for a subject",
                "definition": "Describes an expected sequence of events for one of the participants of a study.  E.g. Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up.",
                "min": 0,
                "max": "*",
                "base": {
                    "path": "ResearchStudy.arm",
                    "min": 0,
                    "max": "*"
                },
                "type":  [
                    {
                        "code": "BackboneElement"
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    }
                ],
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "clinicaltrials-gov",
                        "map": "Arms"
                    },
                    {
                        "identity": "BRIDG5.1",
                        "map": "Arm"
                    }
                ]
            },
            {
                "id": "ResearchStudy.arm.id",
                "path": "ResearchStudy.arm.id",
                "representation":  [
                    "xmlAttr"
                ],
                "short": "Unique id for inter-element referencing",
                "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
                "min": 0,
                "max": "1",
                "base": {
                    "path": "Element.id",
                    "min": 0,
                    "max": "1"
                },
                "type":  [
                    {
                        "extension":  [
                            {
                                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                                "valueUrl": "string"
                            }
                        ],
                        "code": "http://hl7.org/fhirpath/System.String"
                    }
                ],
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    }
                ]
            },
            {
                "id": "ResearchStudy.arm.extension",
                "extension":  [
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
                        "valueCode": "normative"
                    },
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
                        "valueCode": "4.0.0"
                    }
                ],
                "path": "ResearchStudy.arm.extension",
                "slicing": {
                    "discriminator":  [
                        {
                            "type": "value",
                            "path": "url"
                        }
                    ],
                    "description": "Extensions are always sliced by (at least) url",
                    "rules": "open"
                },
                "short": "Additional content defined by implementations",
                "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
                "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
                "alias":  [
                    "extensions",
                    "user content"
                ],
                "min": 0,
                "max": "*",
                "base": {
                    "path": "Element.extension",
                    "min": 0,
                    "max": "*"
                },
                "type":  [
                    {
                        "code": "Extension"
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    },
                    {
                        "key": "ext-1",
                        "severity": "error",
                        "human": "Must have either extensions or value[x], not both",
                        "expression": "extension.exists() != value.exists()",
                        "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
                        "source": "http://hl7.org/fhir/StructureDefinition/Extension"
                    }
                ],
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "rim",
                        "map": "N/A"
                    }
                ]
            },
            {
                "id": "ResearchStudy.arm.modifierExtension",
                "extension":  [
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
                        "valueCode": "normative"
                    },
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
                        "valueCode": "4.0.0"
                    }
                ],
                "path": "ResearchStudy.arm.modifierExtension",
                "short": "Extensions that cannot be ignored even if unrecognized",
                "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
                "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
                "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
                "alias":  [
                    "extensions",
                    "user content",
                    "modifiers"
                ],
                "min": 0,
                "max": "*",
                "base": {
                    "path": "BackboneElement.modifierExtension",
                    "min": 0,
                    "max": "*"
                },
                "type":  [
                    {
                        "code": "Extension"
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    },
                    {
                        "key": "ext-1",
                        "severity": "error",
                        "human": "Must have either extensions or value[x], not both",
                        "expression": "extension.exists() != value.exists()",
                        "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
                        "source": "http://hl7.org/fhir/StructureDefinition/Extension"
                    }
                ],
                "isModifier": true,
                "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
                "isSummary": true,
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "rim",
                        "map": "N/A"
                    }
                ]
            },
            {
                "id": "ResearchStudy.arm.name",
                "path": "ResearchStudy.arm.name",
                "short": "Label for study arm",
                "definition": "Unique, human-readable label for this arm of the study.",
                "comment": "Note that FHIR strings SHALL NOT exceed 1MB in size",
                "min": 1,
                "max": "1",
                "base": {
                    "path": "ResearchStudy.arm.name",
                    "min": 1,
                    "max": "1"
                },
                "type":  [
                    {
                        "code": "string"
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    }
                ],
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "clinicaltrials-gov",
                        "map": "Arm Label"
                    },
                    {
                        "identity": "BRIDG5.1",
                        "map": "Arm.name"
                    }
                ]
            },
            {
                "id": "ResearchStudy.arm.type",
                "extension":  [
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
                        "valueCode": "normative"
                    },
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
                        "valueCode": "4.0.0"
                    }
                ],
                "path": "ResearchStudy.arm.type",
                "short": "Categorization of study arm",
                "definition": "Categorization of study arm, e.g. experimental, active comparator, placebo comparater.",
                "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.",
                "min": 0,
                "max": "1",
                "base": {
                    "path": "ResearchStudy.arm.type",
                    "min": 0,
                    "max": "1"
                },
                "type":  [
                    {
                        "code": "CodeableConcept"
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    }
                ],
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "v2",
                        "map": "CE/CNE/CWE"
                    },
                    {
                        "identity": "rim",
                        "map": "CD"
                    },
                    {
                        "identity": "orim",
                        "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD"
                    },
                    {
                        "identity": "clinicaltrials-gov",
                        "map": "Arm Type"
                    },
                    {
                        "identity": "BRIDG5.1",
                        "map": "Arm.typeCode"
                    }
                ]
            },
            {
                "id": "ResearchStudy.arm.description",
                "path": "ResearchStudy.arm.description",
                "short": "Short explanation of study path",
                "definition": "A succinct description of the path through the study that would be followed by a subject adhering to this arm.",
                "comment": "Note that FHIR strings SHALL NOT exceed 1MB in size",
                "min": 0,
                "max": "1",
                "base": {
                    "path": "ResearchStudy.arm.description",
                    "min": 0,
                    "max": "1"
                },
                "type":  [
                    {
                        "code": "string"
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    }
                ],
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "clinicaltrials-gov",
                        "map": "Arm Description"
                    },
                    {
                        "identity": "BRIDG5.1",
                        "map": "Arm.description"
                    }
                ]
            },
            {
                "id": "ResearchStudy.objective",
                "extension":  [
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
                        "valueCode": "normative"
                    },
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
                        "valueCode": "4.0.0"
                    }
                ],
                "path": "ResearchStudy.objective",
                "short": "A goal for the study",
                "definition": "A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study.",
                "min": 0,
                "max": "*",
                "base": {
                    "path": "ResearchStudy.objective",
                    "min": 0,
                    "max": "*"
                },
                "type":  [
                    {
                        "code": "BackboneElement"
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    }
                ],
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "BRIDG5.1",
                        "map": "StudyObjective"
                    }
                ]
            },
            {
                "id": "ResearchStudy.objective.id",
                "path": "ResearchStudy.objective.id",
                "representation":  [
                    "xmlAttr"
                ],
                "short": "Unique id for inter-element referencing",
                "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
                "min": 0,
                "max": "1",
                "base": {
                    "path": "Element.id",
                    "min": 0,
                    "max": "1"
                },
                "type":  [
                    {
                        "extension":  [
                            {
                                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                                "valueUrl": "string"
                            }
                        ],
                        "code": "http://hl7.org/fhirpath/System.String"
                    }
                ],
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    }
                ]
            },
            {
                "id": "ResearchStudy.objective.extension",
                "extension":  [
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
                        "valueCode": "normative"
                    },
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
                        "valueCode": "4.0.0"
                    }
                ],
                "path": "ResearchStudy.objective.extension",
                "slicing": {
                    "discriminator":  [
                        {
                            "type": "value",
                            "path": "url"
                        }
                    ],
                    "description": "Extensions are always sliced by (at least) url",
                    "rules": "open"
                },
                "short": "Additional content defined by implementations",
                "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
                "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
                "alias":  [
                    "extensions",
                    "user content"
                ],
                "min": 0,
                "max": "*",
                "base": {
                    "path": "Element.extension",
                    "min": 0,
                    "max": "*"
                },
                "type":  [
                    {
                        "code": "Extension"
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    },
                    {
                        "key": "ext-1",
                        "severity": "error",
                        "human": "Must have either extensions or value[x], not both",
                        "expression": "extension.exists() != value.exists()",
                        "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
                        "source": "http://hl7.org/fhir/StructureDefinition/Extension"
                    }
                ],
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "rim",
                        "map": "N/A"
                    }
                ]
            },
            {
                "id": "ResearchStudy.objective.modifierExtension",
                "extension":  [
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
                        "valueCode": "normative"
                    },
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
                        "valueCode": "4.0.0"
                    }
                ],
                "path": "ResearchStudy.objective.modifierExtension",
                "short": "Extensions that cannot be ignored even if unrecognized",
                "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
                "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
                "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
                "alias":  [
                    "extensions",
                    "user content",
                    "modifiers"
                ],
                "min": 0,
                "max": "*",
                "base": {
                    "path": "BackboneElement.modifierExtension",
                    "min": 0,
                    "max": "*"
                },
                "type":  [
                    {
                        "code": "Extension"
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    },
                    {
                        "key": "ext-1",
                        "severity": "error",
                        "human": "Must have either extensions or value[x], not both",
                        "expression": "extension.exists() != value.exists()",
                        "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
                        "source": "http://hl7.org/fhir/StructureDefinition/Extension"
                    }
                ],
                "isModifier": true,
                "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
                "isSummary": true,
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "rim",
                        "map": "N/A"
                    }
                ]
            },
            {
                "id": "ResearchStudy.objective.name",
                "path": "ResearchStudy.objective.name",
                "short": "Label for the objective",
                "definition": "Unique, human-readable label for this objective of the study.",
                "comment": "Note that FHIR strings SHALL NOT exceed 1MB in size",
                "min": 0,
                "max": "1",
                "base": {
                    "path": "ResearchStudy.objective.name",
                    "min": 0,
                    "max": "1"
                },
                "type":  [
                    {
                        "code": "string"
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    }
                ],
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "BRIDG5.1",
                        "map": "No BRIDG mapping (BRIDG has a description, but not a name)"
                    }
                ]
            },
            {
                "id": "ResearchStudy.objective.type",
                "extension":  [
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
                        "valueCode": "normative"
                    },
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
                        "valueCode": "4.0.0"
                    }
                ],
                "path": "ResearchStudy.objective.type",
                "short": "primary | secondary | exploratory",
                "definition": "The kind of study objective.",
                "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.",
                "min": 0,
                "max": "1",
                "base": {
                    "path": "ResearchStudy.objective.type",
                    "min": 0,
                    "max": "1"
                },
                "type":  [
                    {
                        "code": "CodeableConcept"
                    }
                ],
                "condition":  [
                    "ele-1"
                ],
                "constraint":  [
                    {
                        "key": "ele-1",
                        "severity": "error",
                        "human": "All FHIR elements must have a @value or children",
                        "expression": "hasValue() or (children().count() > id.count())",
                        "xpath": "@value|f:*|h:div",
                        "source": "http://hl7.org/fhir/StructureDefinition/Element"
                    }
                ],
                "binding": {
                    "extension":  [
                        {
                            "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
                            "valueString": "ResearchStudyObjectiveType"
                        }
                    ],
                    "strength": "preferred",
                    "description": "Codes for the kind of study objective.",
                    "valueSet": "http://hl7.org/fhir/ValueSet/research-study-objective-type"
                },
                "mapping":  [
                    {
                        "identity": "rim",
                        "map": "n/a"
                    },
                    {
                        "identity": "v2",
                        "map": "CE/CNE/CWE"
                    },
                    {
                        "identity": "rim",
                        "map": "CD"
                    },
                    {
                        "identity": "orim",
                        "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD"
                    },
                    {
                        "identity": "BRIDG5.1",
                        "map": "StudyObjective.typeCode"
                    }
                ]
            }
        ]
    },
    "differential": {
        "element":  [
            {
                "id": "ResearchStudy.status",
                "path": "ResearchStudy.status",
                "fixedCode": "active"
            },
            {
                "id": "ResearchStudy.condition",
                "path": "ResearchStudy.condition",
                "min": 1,
                "binding": {
                    "strength": "required",
                    "description": "The name of an FRB Audit Group.",
                    "valueSet": "https://frbresearch.org/fhir/ValueSet/ssr-research-studies"
                }
            },
            {
                "id": "ResearchStudy.condition.coding",
                "path": "ResearchStudy.condition.coding",
                "min": 1
            },
            {
                "id": "ResearchStudy.condition.coding.code",
                "path": "ResearchStudy.condition.coding.code",
                "min": 1
            }
        ]
    }
}

<StructureDefinition xmlns="http://hl7.org/fhir">
    <url value="https://frbresearch.org/fhir/StructureDefinition/SSRResearchStudy" />
    <name value="SSRResearchStudy" />
    <status value="draft" />
    <description value="An FRB audit group identifying the focus of a study which a patient is involved in." />
    <fhirVersion value="4.0.1" />
    <kind value="resource" />
    <abstract value="false" />
    <type value="ResearchStudy" />
    <baseDefinition value="http://hl7.org/fhir/StructureDefinition/ResearchStudy" />
    <derivation value="constraint" />
    <snapshot>
        <element id="ResearchStudy">
            <path value="ResearchStudy" />
            <short value="Investigation to increase healthcare-related patient-independent knowledge" />
            <definition value="A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge.  This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques.  A ResearchStudy involves the gathering of information about human or animal subjects." />
            <comment value="Need to make sure we encompass public health studies." />
            <alias value="Clinical Trial" />
            <alias value="Study" />
            <min value="0" />
            <max value="*" />
            <base>
                <path value="ResearchStudy" />
                <min value="0" />
                <max value="*" />
            </base>
            <constraint>
                <key value="dom-2" />
                <severity value="error" />
                <human value="If the resource is contained in another resource, it SHALL NOT contain nested Resources" />
                <expression value="contained.contained.empty()" />
                <xpath value="not(parent::f:contained and f:contained)" />
                <source value="http://hl7.org/fhir/StructureDefinition/DomainResource" />
            </constraint>
            <constraint>
                <key value="dom-4" />
                <severity value="error" />
                <human value="If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated" />
                <expression value="contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()" />
                <xpath value="not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))" />
                <source value="http://hl7.org/fhir/StructureDefinition/DomainResource" />
            </constraint>
            <constraint>
                <key value="dom-3" />
                <severity value="error" />
                <human value="If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource" />
                <expression value="contained.where(((&#39;#&#39;+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = &#39;#&#39;).exists() or descendants().where(as(canonical) = &#39;#&#39;).exists() or descendants().where(as(canonical) = &#39;#&#39;).exists()).not()).trace(&#39;unmatched&#39;, id).empty()" />
                <xpath value="not(exists(for $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat(&#39;#&#39;, $contained/*/id/@value) or descendant::f:reference[@value=&#39;#&#39;])]))" />
                <source value="http://hl7.org/fhir/StructureDefinition/DomainResource" />
            </constraint>
            <constraint>
                <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice">
                    <valueBoolean value="true" />
                </extension>
                <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation">
                    <valueMarkdown value="When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time." />
                </extension>
                <key value="dom-6" />
                <severity value="warning" />
                <human value="A resource should have narrative for robust management" />
                <expression value="text.`div`.exists()" />
                <xpath value="exists(f:text/h:div)" />
                <source value="http://hl7.org/fhir/StructureDefinition/DomainResource" />
            </constraint>
            <constraint>
                <key value="dom-5" />
                <severity value="error" />
                <human value="If a resource is contained in another resource, it SHALL NOT have a security label" />
                <expression value="contained.meta.security.empty()" />
                <xpath value="not(exists(f:contained/*/f:meta/f:security))" />
                <source value="http://hl7.org/fhir/StructureDefinition/DomainResource" />
            </constraint>
            <mapping>
                <identity value="rim" />
                <map value="Entity. Role, or Act" />
            </mapping>
            <mapping>
                <identity value="BRIDG5.1" />
                <map value="ObservationalStudyProtocolVersion; Study;\nStudyProtocolVersion" />
            </mapping>
            <mapping>
                <identity value="v2" />
                <map value="OBX" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value="Observation[classCode=CLNTRL, moodCode=EVN]" />
            </mapping>
        </element>
        <element id="ResearchStudy.id">
            <path value="ResearchStudy.id" />
            <short value="Logical id of this artifact" />
            <definition value="The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes." />
            <comment value="The only time that a resource does not have an id is when it is being submitted to the server using a create operation." />
            <min value="0" />
            <max value="1" />
            <base>
                <path value="Resource.id" />
                <min value="0" />
                <max value="1" />
            </base>
            <type>
                <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
                    <valueUrl value="string" />
                </extension>
                <code value="http://hl7.org/fhirpath/System.String" />
            </type>
            <isSummary value="true" />
        </element>
        <element id="ResearchStudy.meta">
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
                <valueCode value="normative" />
            </extension>
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
                <valueCode value="4.0.0" />
            </extension>
            <path value="ResearchStudy.meta" />
            <short value="Metadata about the resource" />
            <definition value="The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource." />
            <min value="0" />
            <max value="1" />
            <base>
                <path value="Resource.meta" />
                <min value="0" />
                <max value="1" />
            </base>
            <type>
                <code value="Meta" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <isSummary value="true" />
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value="N/A" />
            </mapping>
        </element>
        <element id="ResearchStudy.implicitRules">
            <path value="ResearchStudy.implicitRules" />
            <short value="A set of rules under which this content was created" />
            <definition value="A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc." />
            <comment value="Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it&#39;s narrative along with other profiles, value sets, etc." />
            <min value="0" />
            <max value="1" />
            <base>
                <path value="Resource.implicitRules" />
                <min value="0" />
                <max value="1" />
            </base>
            <type>
                <code value="uri" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <isModifier value="true" />
            <isModifierReason value="This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it&#39;s meaning or interpretation" />
            <isSummary value="true" />
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
        </element>
        <element id="ResearchStudy.language">
            <path value="ResearchStudy.language" />
            <short value="Language of the resource content" />
            <definition value="The base language in which the resource is written." />
            <comment value="Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies  to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute)." />
            <min value="0" />
            <max value="1" />
            <base>
                <path value="Resource.language" />
                <min value="0" />
                <max value="1" />
            </base>
            <type>
                <code value="code" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <binding>
                <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet">
                    <valueCanonical value="http://hl7.org/fhir/ValueSet/all-languages" />
                </extension>
                <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
                    <valueString value="Language" />
                </extension>
                <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding">
                    <valueBoolean value="true" />
                </extension>
                <strength value="preferred" />
                <description value="A human language." />
                <valueSet value="http://hl7.org/fhir/ValueSet/languages" />
            </binding>
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
        </element>
        <element id="ResearchStudy.text">
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
                <valueCode value="normative" />
            </extension>
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
                <valueCode value="4.0.0" />
            </extension>
            <path value="ResearchStudy.text" />
            <short value="Text summary of the resource, for human interpretation" />
            <definition value="A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it &quot;clinically safe&quot; for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety." />
            <comment value="Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied).  This may be necessary for data from legacy systems where information is captured as a &quot;text blob&quot; or where text is additionally entered raw or narrated and encoded information is added later." />
            <alias value="narrative" />
            <alias value="html" />
            <alias value="xhtml" />
            <alias value="display" />
            <min value="0" />
            <max value="1" />
            <base>
                <path value="DomainResource.text" />
                <min value="0" />
                <max value="1" />
            </base>
            <type>
                <code value="Narrative" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value="N/A" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value="Act.text?" />
            </mapping>
        </element>
        <element id="ResearchStudy.contained">
            <path value="ResearchStudy.contained" />
            <short value="Contained, inline Resources" />
            <definition value="These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope." />
            <comment value="This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels." />
            <alias value="inline resources" />
            <alias value="anonymous resources" />
            <alias value="contained resources" />
            <min value="0" />
            <max value="*" />
            <base>
                <path value="DomainResource.contained" />
                <min value="0" />
                <max value="*" />
            </base>
            <type>
                <code value="Resource" />
            </type>
            <mapping>
                <identity value="rim" />
                <map value="Entity. Role, or Act" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value="N/A" />
            </mapping>
        </element>
        <element id="ResearchStudy.extension">
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
                <valueCode value="normative" />
            </extension>
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
                <valueCode value="4.0.0" />
            </extension>
            <path value="ResearchStudy.extension" />
            <slicing>
                <discriminator>
                    <type value="value" />
                    <path value="url" />
                </discriminator>
                <description value="Extensions are always sliced by (at least) url" />
                <rules value="open" />
            </slicing>
            <short value="Additional content defined by implementations" />
            <definition value="May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." />
            <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
            <alias value="extensions" />
            <alias value="user content" />
            <min value="0" />
            <max value="*" />
            <base>
                <path value="DomainResource.extension" />
                <min value="0" />
                <max value="*" />
            </base>
            <type>
                <code value="Extension" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <constraint>
                <key value="ext-1" />
                <severity value="error" />
                <human value="Must have either extensions or value[x], not both" />
                <expression value="extension.exists() != value.exists()" />
                <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &#39;value&#39;)])" />
                <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
            </constraint>
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value="N/A" />
            </mapping>
        </element>
        <element id="ResearchStudy.modifierExtension">
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
                <valueCode value="normative" />
            </extension>
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
                <valueCode value="4.0.0" />
            </extension>
            <path value="ResearchStudy.modifierExtension" />
            <slicing>
                <discriminator>
                    <type value="value" />
                    <path value="url" />
                </discriminator>
                <description value="Extensions are always sliced by (at least) url" />
                <rules value="open" />
            </slicing>
            <short value="Extensions that cannot be ignored" />
            <definition value="May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element&#39;s descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." />
            <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
            <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension)." />
            <alias value="extensions" />
            <alias value="user content" />
            <min value="0" />
            <max value="*" />
            <base>
                <path value="DomainResource.modifierExtension" />
                <min value="0" />
                <max value="*" />
            </base>
            <type>
                <code value="Extension" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <constraint>
                <key value="ext-1" />
                <severity value="error" />
                <human value="Must have either extensions or value[x], not both" />
                <expression value="extension.exists() != value.exists()" />
                <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &#39;value&#39;)])" />
                <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
            </constraint>
            <isModifier value="true" />
            <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them" />
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value="N/A" />
            </mapping>
        </element>
        <element id="ResearchStudy.identifier">
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
                <valueCode value="normative" />
            </extension>
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
                <valueCode value="4.0.0" />
            </extension>
            <path value="ResearchStudy.identifier" />
            <short value="Business Identifier for study" />
            <definition value="Identifiers assigned to this research study by the sponsor or other systems." />
            <requirements value="Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers." />
            <min value="0" />
            <max value="*" />
            <base>
                <path value="ResearchStudy.identifier" />
                <min value="0" />
                <max value="*" />
            </base>
            <type>
                <code value="Identifier" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <isSummary value="true" />
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="v2" />
                <map value="CX / EI (occasionally, more often EI maps to a resource id or a URL)" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value="II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs.  Also maps to Role[classCode=IDENT]" />
            </mapping>
            <mapping>
                <identity value="servd" />
                <map value="Identifier" />
            </mapping>
            <mapping>
                <identity value="clinicaltrials-gov" />
                <map value="Organization&#39;s Unique Protocol ID; Secondary IDs" />
            </mapping>
            <mapping>
                <identity value="w5" />
                <map value="FiveWs.identifier" />
            </mapping>
            <mapping>
                <identity value="BRIDG5.1" />
                <map value="No BRIDG mapping (although there is  DocumentVersion.identifier &gt; StudyProtocolDocumentVersion, this is arguably a different semantic)" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value=".identifier" />
            </mapping>
        </element>
        <element id="ResearchStudy.title">
            <path value="ResearchStudy.title" />
            <short value="Name for this study" />
            <definition value="A short, descriptive user-friendly label for the study." />
            <comment value="Note that FHIR strings SHALL NOT exceed 1MB in size" />
            <min value="0" />
            <max value="1" />
            <base>
                <path value="ResearchStudy.title" />
                <min value="0" />
                <max value="1" />
            </base>
            <type>
                <code value="string" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <isSummary value="true" />
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="clinicaltrials-gov" />
                <map value="Brief Title" />
            </mapping>
            <mapping>
                <identity value="BRIDG5.1" />
                <map value="No BRIDG mapping (although there is  StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)" />
            </mapping>
        </element>
        <element id="ResearchStudy.protocol">
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
                <valueCode value="normative" />
            </extension>
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
                <valueCode value="4.0.0" />
            </extension>
            <path value="ResearchStudy.protocol" />
            <short value="Steps followed in executing study" />
            <definition value="The set of steps expected to be performed as part of the execution of the study." />
            <comment value="References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository." />
            <min value="0" />
            <max value="*" />
            <base>
                <path value="ResearchStudy.protocol" />
                <min value="0" />
                <max value="*" />
            </base>
            <type>
                <code value="Reference" />
                <targetProfile value="http://hl7.org/fhir/StructureDefinition/PlanDefinition" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <constraint>
                <key value="ref-1" />
                <severity value="error" />
                <human value="SHALL have a contained resource if a local reference is provided" />
                <expression value="reference.startsWith(&#39;#&#39;).not() or (reference.substring(1).trace(&#39;url&#39;) in %rootResource.contained.id.trace(&#39;ids&#39;))" />
                <xpath value="not(starts-with(f:reference/@value, &#39;#&#39;)) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, &#39;#&#39;)]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, &#39;#&#39;)])" />
                <source value="http://hl7.org/fhir/StructureDefinition/Reference" />
            </constraint>
            <isSummary value="true" />
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value="The target of a resource reference is a RIM entry point (Act, Role, or Entity)" />
            </mapping>
            <mapping>
                <identity value="clinicaltrials-gov" />
                <map value="Interventions; Arm/Intervention Cross-Reference" />
            </mapping>
            <mapping>
                <identity value="BRIDG5.1" />
                <map value="StudyProtocolDocumentVersionPublicTitle.name" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value=".outboundRelationship[typeCode=DEFN].target" />
            </mapping>
        </element>
        <element id="ResearchStudy.partOf">
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
                <valueCode value="normative" />
            </extension>
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
                <valueCode value="4.0.0" />
            </extension>
            <path value="ResearchStudy.partOf" />
            <short value="Part of larger study" />
            <definition value="A larger research study of which this particular study is a component or step." />
            <comment value="References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository." />
            <requirements value="Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc." />
            <alias value="container" />
            <min value="0" />
            <max value="*" />
            <base>
                <path value="ResearchStudy.partOf" />
                <min value="0" />
                <max value="*" />
            </base>
            <type>
                <code value="Reference" />
                <targetProfile value="http://hl7.org/fhir/StructureDefinition/ResearchStudy" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <constraint>
                <key value="ref-1" />
                <severity value="error" />
                <human value="SHALL have a contained resource if a local reference is provided" />
                <expression value="reference.startsWith(&#39;#&#39;).not() or (reference.substring(1).trace(&#39;url&#39;) in %rootResource.contained.id.trace(&#39;ids&#39;))" />
                <xpath value="not(starts-with(f:reference/@value, &#39;#&#39;)) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, &#39;#&#39;)]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, &#39;#&#39;)])" />
                <source value="http://hl7.org/fhir/StructureDefinition/Reference" />
            </constraint>
            <isSummary value="true" />
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value="The target of a resource reference is a RIM entry point (Act, Role, or Entity)" />
            </mapping>
            <mapping>
                <identity value="BRIDG5.1" />
                <map value="CompanionStudyRelationship" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value=".inboundRelationship[typeCode=COMP].source[moodCode=EVN]" />
            </mapping>
        </element>
        <element id="ResearchStudy.status">
            <path value="ResearchStudy.status" />
            <short value="active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn" />
            <definition value="The current state of the study." />
            <comment value="Note that FHIR strings SHALL NOT exceed 1MB in size" />
            <min value="1" />
            <max value="1" />
            <base>
                <path value="ResearchStudy.status" />
                <min value="1" />
                <max value="1" />
            </base>
            <type>
                <code value="code" />
            </type>
            <fixedCode value="active" />
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <isModifier value="true" />
            <isModifierReason value="This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid" />
            <isSummary value="true" />
            <binding>
                <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
                    <valueString value="ResearchStudyStatus" />
                </extension>
                <strength value="required" />
                <description value="Codes that convey the current status of the research study." />
                <valueSet value="http://hl7.org/fhir/ValueSet/research-study-status|4.0.1" />
            </binding>
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="w5" />
                <map value="FiveWs.status" />
            </mapping>
            <mapping>
                <identity value="BRIDG5.1" />
                <map value="StudyOverallStatus.code" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value=".status" />
            </mapping>
        </element>
        <element id="ResearchStudy.primaryPurposeType">
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
                <valueCode value="normative" />
            </extension>
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
                <valueCode value="4.0.0" />
            </extension>
            <path value="ResearchStudy.primaryPurposeType" />
            <short value="treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility" />
            <definition value="The type of study based upon the intent of the study&#39;s activities. A classification of the intent of the study." />
            <comment value="Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination." />
            <min value="0" />
            <max value="1" />
            <base>
                <path value="ResearchStudy.primaryPurposeType" />
                <min value="0" />
                <max value="1" />
            </base>
            <type>
                <code value="CodeableConcept" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <isSummary value="true" />
            <binding>
                <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
                    <valueString value="ResearchStudyPrimaryPurposeType" />
                </extension>
                <strength value="extensible" />
                <description value="Codes for the main intent of the study." />
                <valueSet value="http://hl7.org/fhir/ValueSet/research-study-prim-purp-type" />
            </binding>
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="v2" />
                <map value="CE/CNE/CWE" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value="CD" />
            </mapping>
            <mapping>
                <identity value="orim" />
                <map value="fhir:CodeableConcept rdfs:subClassOf dt:CD" />
            </mapping>
            <mapping>
                <identity value="BRIDG5.1" />
                <map value="StudyProtocolVersion.primaryPurposeTypeCode" />
            </mapping>
        </element>
        <element id="ResearchStudy.phase">
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
                <valueCode value="normative" />
            </extension>
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
                <valueCode value="4.0.0" />
            </extension>
            <path value="ResearchStudy.phase" />
            <short value="n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4" />
            <definition value="The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation." />
            <comment value="Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination." />
            <min value="0" />
            <max value="1" />
            <base>
                <path value="ResearchStudy.phase" />
                <min value="0" />
                <max value="1" />
            </base>
            <type>
                <code value="CodeableConcept" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <isSummary value="true" />
            <binding>
                <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
                    <valueString value="ResearchStudyPhase" />
                </extension>
                <strength value="example" />
                <description value="Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation." />
                <valueSet value="http://hl7.org/fhir/ValueSet/research-study-phase" />
            </binding>
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="v2" />
                <map value="CE/CNE/CWE" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value="CD" />
            </mapping>
            <mapping>
                <identity value="orim" />
                <map value="fhir:CodeableConcept rdfs:subClassOf dt:CD" />
            </mapping>
            <mapping>
                <identity value="clinicaltrials-gov" />
                <map value="Study Phase" />
            </mapping>
            <mapping>
                <identity value="BRIDG5.1" />
                <map value="StudyProtocolVersion.phaseCode" />
            </mapping>
        </element>
        <element id="ResearchStudy.category">
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
                <valueCode value="normative" />
            </extension>
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
                <valueCode value="4.0.0" />
            </extension>
            <path value="ResearchStudy.category" />
            <short value="Classifications for the study" />
            <definition value="Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc." />
            <comment value="Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination." />
            <min value="0" />
            <max value="*" />
            <base>
                <path value="ResearchStudy.category" />
                <min value="0" />
                <max value="*" />
            </base>
            <type>
                <code value="CodeableConcept" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <isSummary value="true" />
            <binding>
                <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
                    <valueString value="ResearchStudyCategory" />
                </extension>
                <strength value="example" />
                <description value="Codes that describe the type of research study.  E.g. Study phase, Interventional/Observational, blinding type, etc." />
            </binding>
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="v2" />
                <map value="CE/CNE/CWE" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value="CD" />
            </mapping>
            <mapping>
                <identity value="orim" />
                <map value="fhir:CodeableConcept rdfs:subClassOf dt:CD" />
            </mapping>
            <mapping>
                <identity value="clinicaltrials-gov" />
                <map value="Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention" />
            </mapping>
            <mapping>
                <identity value="BRIDG5.1" />
                <map value="InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode" />
            </mapping>
        </element>
        <element id="ResearchStudy.focus">
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
                <valueCode value="normative" />
            </extension>
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
                <valueCode value="4.0.0" />
            </extension>
            <path value="ResearchStudy.focus" />
            <short value="Drugs, devices, etc. under study" />
            <definition value="The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about." />
            <comment value="Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination." />
            <min value="0" />
            <max value="*" />
            <base>
                <path value="ResearchStudy.focus" />
                <min value="0" />
                <max value="*" />
            </base>
            <type>
                <code value="CodeableConcept" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <isSummary value="true" />
            <binding>
                <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
                    <valueString value="ResearchStudyFocus" />
                </extension>
                <strength value="example" />
                <description value="Codes for medications, devices and other interventions." />
            </binding>
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="v2" />
                <map value="CE/CNE/CWE" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value="CD" />
            </mapping>
            <mapping>
                <identity value="orim" />
                <map value="fhir:CodeableConcept rdfs:subClassOf dt:CD" />
            </mapping>
            <mapping>
                <identity value="clinicaltrials-gov" />
                <map value="Focus of Study" />
            </mapping>
            <mapping>
                <identity value="w5" />
                <map value="FiveWs.what[x]" />
            </mapping>
            <mapping>
                <identity value="BRIDG5.1" />
                <map value="InterventionalStudyProtocol.interventionTypeCode" />
            </mapping>
        </element>
        <element id="ResearchStudy.condition">
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
                <valueCode value="normative" />
            </extension>
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
                <valueCode value="4.0.0" />
            </extension>
            <path value="ResearchStudy.condition" />
            <short value="Condition being studied" />
            <definition value="The condition that is the focus of the study.  For example, In a study to examine risk factors for Lupus, might have as an inclusion criterion &quot;healthy volunteer&quot;, but the target condition code would be a Lupus SNOMED code." />
            <comment value="Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination." />
            <min value="1" />
            <max value="*" />
            <base>
                <path value="ResearchStudy.condition" />
                <min value="0" />
                <max value="*" />
            </base>
            <type>
                <code value="CodeableConcept" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <isSummary value="true" />
            <binding>
                <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
                    <valueString value="ConditionCode" />
                </extension>
                <strength value="required" />
                <description value="The name of an FRB Audit Group." />
                <valueSet value="https://frbresearch.org/fhir/ValueSet/ssr-research-studies" />
            </binding>
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="v2" />
                <map value="CE/CNE/CWE" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value="CD" />
            </mapping>
            <mapping>
                <identity value="orim" />
                <map value="fhir:CodeableConcept rdfs:subClassOf dt:CD" />
            </mapping>
            <mapping>
                <identity value="clinicaltrials-gov" />
                <map value="Conditions" />
            </mapping>
            <mapping>
                <identity value="w5" />
                <map value="FiveWs.what[x]" />
            </mapping>
            <mapping>
                <identity value="BRIDG5.1" />
                <map value="StudyCondition.code" />
            </mapping>
        </element>
        <element id="ResearchStudy.condition.id">
            <path value="ResearchStudy.condition.id" />
            <representation value="xmlAttr" />
            <short value="Unique id for inter-element referencing" />
            <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
            <min value="0" />
            <max value="1" />
            <base>
                <path value="Element.id" />
                <min value="0" />
                <max value="1" />
            </base>
            <type>
                <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
                    <valueUrl value="string" />
                </extension>
                <code value="http://hl7.org/fhirpath/System.String" />
            </type>
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
        </element>
        <element id="ResearchStudy.condition.extension">
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
                <valueCode value="normative" />
            </extension>
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
                <valueCode value="4.0.0" />
            </extension>
            <path value="ResearchStudy.condition.extension" />
            <slicing>
                <discriminator>
                    <type value="value" />
                    <path value="url" />
                </discriminator>
                <description value="Extensions are always sliced by (at least) url" />
                <rules value="open" />
            </slicing>
            <short value="Additional content defined by implementations" />
            <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." />
            <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
            <alias value="extensions" />
            <alias value="user content" />
            <min value="0" />
            <max value="*" />
            <base>
                <path value="Element.extension" />
                <min value="0" />
                <max value="*" />
            </base>
            <type>
                <code value="Extension" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <constraint>
                <key value="ext-1" />
                <severity value="error" />
                <human value="Must have either extensions or value[x], not both" />
                <expression value="extension.exists() != value.exists()" />
                <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &#39;value&#39;)])" />
                <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
            </constraint>
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value="N/A" />
            </mapping>
        </element>
        <element id="ResearchStudy.condition.coding">
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
                <valueCode value="normative" />
            </extension>
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
                <valueCode value="4.0.0" />
            </extension>
            <path value="ResearchStudy.condition.coding" />
            <short value="Code defined by a terminology system" />
            <definition value="A reference to a code defined by a terminology system." />
            <comment value="Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true." />
            <requirements value="Allows for alternative encodings within a code system, and translations to other code systems." />
            <min value="1" />
            <max value="*" />
            <base>
                <path value="CodeableConcept.coding" />
                <min value="0" />
                <max value="*" />
            </base>
            <type>
                <code value="Coding" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <isSummary value="true" />
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="v2" />
                <map value="CE/CNE/CWE subset one of the sets of component 1-3 or 4-6" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value="CV" />
            </mapping>
            <mapping>
                <identity value="orim" />
                <map value="fhir:Coding rdfs:subClassOf dt:CDCoding" />
            </mapping>
            <mapping>
                <identity value="v2" />
                <map value="C*E.1-8, C*E.10-22" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value="union(., ./translation)" />
            </mapping>
            <mapping>
                <identity value="orim" />
                <map value="fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding" />
            </mapping>
        </element>
        <element id="ResearchStudy.condition.coding.id">
            <path value="ResearchStudy.condition.coding.id" />
            <representation value="xmlAttr" />
            <short value="Unique id for inter-element referencing" />
            <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
            <min value="0" />
            <max value="1" />
            <base>
                <path value="Element.id" />
                <min value="0" />
                <max value="1" />
            </base>
            <type>
                <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
                    <valueUrl value="string" />
                </extension>
                <code value="http://hl7.org/fhirpath/System.String" />
            </type>
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
        </element>
        <element id="ResearchStudy.condition.coding.extension">
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
                <valueCode value="normative" />
            </extension>
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
                <valueCode value="4.0.0" />
            </extension>
            <path value="ResearchStudy.condition.coding.extension" />
            <slicing>
                <discriminator>
                    <type value="value" />
                    <path value="url" />
                </discriminator>
                <description value="Extensions are always sliced by (at least) url" />
                <rules value="open" />
            </slicing>
            <short value="Additional content defined by implementations" />
            <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." />
            <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
            <alias value="extensions" />
            <alias value="user content" />
            <min value="0" />
            <max value="*" />
            <base>
                <path value="Element.extension" />
                <min value="0" />
                <max value="*" />
            </base>
            <type>
                <code value="Extension" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <constraint>
                <key value="ext-1" />
                <severity value="error" />
                <human value="Must have either extensions or value[x], not both" />
                <expression value="extension.exists() != value.exists()" />
                <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &#39;value&#39;)])" />
                <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
            </constraint>
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value="N/A" />
            </mapping>
        </element>
        <element id="ResearchStudy.condition.coding.system">
            <path value="ResearchStudy.condition.coding.system" />
            <short value="Identity of the terminology system" />
            <definition value="The identification of the code system that defines the meaning of the symbol in the code." />
            <comment value="The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...).  OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7&#39;s list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously." />
            <requirements value="Need to be unambiguous about the source of the definition of the symbol." />
            <min value="0" />
            <max value="1" />
            <base>
                <path value="Coding.system" />
                <min value="0" />
                <max value="1" />
            </base>
            <type>
                <code value="uri" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <isSummary value="true" />
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="v2" />
                <map value="C*E.3" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value="./codeSystem" />
            </mapping>
            <mapping>
                <identity value="orim" />
                <map value="fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem" />
            </mapping>
        </element>
        <element id="ResearchStudy.condition.coding.version">
            <path value="ResearchStudy.condition.coding.version" />
            <short value="Version of the system - if relevant" />
            <definition value="The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged." />
            <comment value="Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date." />
            <min value="0" />
            <max value="1" />
            <base>
                <path value="Coding.version" />
                <min value="0" />
                <max value="1" />
            </base>
            <type>
                <code value="string" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <isSummary value="true" />
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="v2" />
                <map value="C*E.7" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value="./codeSystemVersion" />
            </mapping>
            <mapping>
                <identity value="orim" />
                <map value="fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion" />
            </mapping>
        </element>
        <element id="ResearchStudy.condition.coding.code">
            <path value="ResearchStudy.condition.coding.code" />
            <short value="Symbol in syntax defined by the system" />
            <definition value="A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination)." />
            <comment value="Note that FHIR strings SHALL NOT exceed 1MB in size" />
            <requirements value="Need to refer to a particular code in the system." />
            <min value="1" />
            <max value="1" />
            <base>
                <path value="Coding.code" />
                <min value="0" />
                <max value="1" />
            </base>
            <type>
                <code value="code" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <isSummary value="true" />
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="v2" />
                <map value="C*E.1" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value="./code" />
            </mapping>
            <mapping>
                <identity value="orim" />
                <map value="fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code" />
            </mapping>
        </element>
        <element id="ResearchStudy.condition.coding.display">
            <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
                <valueBoolean value="true" />
            </extension>
            <path value="ResearchStudy.condition.coding.display" />
            <short value="Representation defined by the system" />
            <definition value="A representation of the meaning of the code in the system, following the rules of the system." />
            <comment value="Note that FHIR strings SHALL NOT exceed 1MB in size" />
            <requirements value="Need to be able to carry a human-readable meaning of the code for readers that do not know  the system." />
            <min value="0" />
            <max value="1" />
            <base>
                <path value="Coding.display" />
                <min value="0" />
                <max value="1" />
            </base>
            <type>
                <code value="string" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <isSummary value="true" />
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="v2" />
                <map value="C*E.2 - but note this is not well followed" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value="CV.displayName" />
            </mapping>
            <mapping>
                <identity value="orim" />
                <map value="fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName" />
            </mapping>
        </element>
        <element id="ResearchStudy.condition.coding.userSelected">
            <path value="ResearchStudy.condition.coding.userSelected" />
            <short value="If this coding was chosen directly by the user" />
            <definition value="Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays)." />
            <comment value="Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly &#39;directly chosen&#39; implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely." />
            <requirements value="This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing." />
            <min value="0" />
            <max value="1" />
            <base>
                <path value="Coding.userSelected" />
                <min value="0" />
                <max value="1" />
            </base>
            <type>
                <code value="boolean" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <isSummary value="true" />
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="v2" />
                <map value="Sometimes implied by being first" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value="CD.codingRationale" />
            </mapping>
            <mapping>
                <identity value="orim" />
                <map value="fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map;   fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [     fhir:source &quot;true&quot;;     fhir:target dt:CDCoding.codingRationale\#O   ]" />
            </mapping>
        </element>
        <element id="ResearchStudy.condition.text">
            <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
                <valueBoolean value="true" />
            </extension>
            <path value="ResearchStudy.condition.text" />
            <short value="Plain text representation of the concept" />
            <definition value="A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user." />
            <comment value="Very often the text is the same as a displayName of one of the codings." />
            <requirements value="The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source." />
            <min value="0" />
            <max value="1" />
            <base>
                <path value="CodeableConcept.text" />
                <min value="0" />
                <max value="1" />
            </base>
            <type>
                <code value="string" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <isSummary value="true" />
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="v2" />
                <map value="C*E.9. But note many systems use C*E.2 for this" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value="./originalText[mediaType/code=&quot;text/plain&quot;]/data" />
            </mapping>
            <mapping>
                <identity value="orim" />
                <map value="fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText" />
            </mapping>
        </element>
        <element id="ResearchStudy.contact">
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
                <valueCode value="normative" />
            </extension>
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
                <valueCode value="4.0.0" />
            </extension>
            <path value="ResearchStudy.contact" />
            <short value="Contact details for the study" />
            <definition value="Contact details to assist a user in learning more about or engaging with the study." />
            <min value="0" />
            <max value="*" />
            <base>
                <path value="ResearchStudy.contact" />
                <min value="0" />
                <max value="*" />
            </base>
            <type>
                <code value="ContactDetail" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <isSummary value="true" />
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="clinicaltrials-gov" />
                <map value="Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact &amp; Backup (if Study tied to only one location); Investigators" />
            </mapping>
            <mapping>
                <identity value="BRIDG5.1" />
                <map value="PointOfContact &gt; Project &gt; Research Project &gt; Study &gt; StudyProtocol &gt; StudyProtocolVersion" />
            </mapping>
        </element>
        <element id="ResearchStudy.relatedArtifact">
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
                <valueCode value="trial-use" />
            </extension>
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
                <valueCode value="4.0.0" />
            </extension>
            <path value="ResearchStudy.relatedArtifact" />
            <short value="References and dependencies" />
            <definition value="Citations, references and other related documents." />
            <comment value="Each related artifact is either an attachment, or a reference to another knowledge resource, but not both." />
            <min value="0" />
            <max value="*" />
            <base>
                <path value="ResearchStudy.relatedArtifact" />
                <min value="0" />
                <max value="*" />
            </base>
            <type>
                <code value="RelatedArtifact" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="clinicaltrials-gov" />
                <map value="Citations, Links, Available Study Data/Documents" />
            </mapping>
            <mapping>
                <identity value="BRIDG5.1" />
                <map value="StudyProtocolDocument, StudyProtocolDocumentVersion" />
            </mapping>
        </element>
        <element id="ResearchStudy.keyword">
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
                <valueCode value="normative" />
            </extension>
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
                <valueCode value="4.0.0" />
            </extension>
            <path value="ResearchStudy.keyword" />
            <short value="Used to search for the study" />
            <definition value="Key terms to aid in searching for or filtering the study." />
            <comment value="Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination." />
            <min value="0" />
            <max value="*" />
            <base>
                <path value="ResearchStudy.keyword" />
                <min value="0" />
                <max value="*" />
            </base>
            <type>
                <code value="CodeableConcept" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <isSummary value="true" />
            <binding>
                <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
                    <valueString value="ResearchStudyKeyword" />
                </extension>
                <strength value="example" />
                <description value="Words associated with the study that may be useful in discovery." />
            </binding>
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="v2" />
                <map value="CE/CNE/CWE" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value="CD" />
            </mapping>
            <mapping>
                <identity value="orim" />
                <map value="fhir:CodeableConcept rdfs:subClassOf dt:CD" />
            </mapping>
            <mapping>
                <identity value="clinicaltrials-gov" />
                <map value="Keywords" />
            </mapping>
            <mapping>
                <identity value="BRIDG5.1" />
                <map value="DocumentVersion.keywordCode; DocumentVersion.keywordText" />
            </mapping>
        </element>
        <element id="ResearchStudy.location">
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
                <valueCode value="normative" />
            </extension>
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
                <valueCode value="4.0.0" />
            </extension>
            <path value="ResearchStudy.location" />
            <short value="Geographic region(s) for study" />
            <definition value="Indicates a country, state or other region where the study is taking place." />
            <comment value="Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination." />
            <min value="0" />
            <max value="*" />
            <base>
                <path value="ResearchStudy.location" />
                <min value="0" />
                <max value="*" />
            </base>
            <type>
                <code value="CodeableConcept" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <isSummary value="true" />
            <binding>
                <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
                    <valueString value="Jurisdiction" />
                </extension>
                <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding">
                    <valueBoolean value="true" />
                </extension>
                <strength value="extensible" />
                <description value="Countries and regions within which this artifact is targeted for use." />
                <valueSet value="http://hl7.org/fhir/ValueSet/jurisdiction" />
            </binding>
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="v2" />
                <map value="CE/CNE/CWE" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value="CD" />
            </mapping>
            <mapping>
                <identity value="orim" />
                <map value="fhir:CodeableConcept rdfs:subClassOf dt:CD" />
            </mapping>
            <mapping>
                <identity value="BRIDG5.1" />
                <map value="StudyProtocolVersion.participatingLocationCode" />
            </mapping>
        </element>
        <element id="ResearchStudy.description">
            <path value="ResearchStudy.description" />
            <short value="What this is study doing" />
            <definition value="A full description of how the study is being conducted." />
            <comment value="Systems are not required to have markdown support, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/" />
            <min value="0" />
            <max value="1" />
            <base>
                <path value="ResearchStudy.description" />
                <min value="0" />
                <max value="1" />
            </base>
            <type>
                <code value="markdown" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="clinicaltrials-gov" />
                <map value="Detailed Description" />
            </mapping>
            <mapping>
                <identity value="BRIDG5.1" />
                <map value="StudyProtocolDocumentVersion.publicDescription" />
            </mapping>
        </element>
        <element id="ResearchStudy.enrollment">
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
                <valueCode value="normative" />
            </extension>
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
                <valueCode value="4.0.0" />
            </extension>
            <path value="ResearchStudy.enrollment" />
            <short value="Inclusion &amp; exclusion criteria" />
            <definition value="Reference to a Group that defines the criteria for and quantity of subjects participating in the study.  E.g. &quot; 200 female Europeans between the ages of 20 and 45 with early onset diabetes&quot;." />
            <comment value="The Group referenced should not generally enumerate specific subjects.  Subjects will be linked to the study using the ResearchSubject resource." />
            <alias value="patient" />
            <min value="0" />
            <max value="*" />
            <base>
                <path value="ResearchStudy.enrollment" />
                <min value="0" />
                <max value="*" />
            </base>
            <type>
                <code value="Reference" />
                <targetProfile value="http://hl7.org/fhir/StructureDefinition/Group" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <constraint>
                <key value="ref-1" />
                <severity value="error" />
                <human value="SHALL have a contained resource if a local reference is provided" />
                <expression value="reference.startsWith(&#39;#&#39;).not() or (reference.substring(1).trace(&#39;url&#39;) in %rootResource.contained.id.trace(&#39;ids&#39;))" />
                <xpath value="not(starts-with(f:reference/@value, &#39;#&#39;)) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, &#39;#&#39;)]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, &#39;#&#39;)])" />
                <source value="http://hl7.org/fhir/StructureDefinition/Reference" />
            </constraint>
            <isSummary value="true" />
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value="The target of a resource reference is a RIM entry point (Act, Role, or Entity)" />
            </mapping>
            <mapping>
                <identity value="clinicaltrials-gov" />
                <map value="Enrollment; Number of Groups/Cohorts (= number of &quot;enrollment&quot; instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)" />
            </mapping>
            <mapping>
                <identity value="w5" />
                <map value="FiveWs.subject[x]" />
            </mapping>
            <mapping>
                <identity value="BRIDG5.1" />
                <map value="InterventionalStudyProtocol.interventionGroupQuantity" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value=".participation[typeCode=SBJ].role" />
            </mapping>
            <mapping>
                <identity value="w5" />
                <map value="FiveWs.subject" />
            </mapping>
        </element>
        <element id="ResearchStudy.period">
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
                <valueCode value="normative" />
            </extension>
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
                <valueCode value="4.0.0" />
            </extension>
            <path value="ResearchStudy.period" />
            <short value="When the study began and ended" />
            <definition value="Identifies the start date and the expected (or actual, depending on status) end date for the study." />
            <comment value="A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. &quot;the patient was an inpatient of the hospital for this time range&quot;) or one value from the range applies (e.g. &quot;give to the patient between these two times&quot;).\n\nPeriod is not used for a duration (a measure of elapsed time). See [Duration](datatypes.html#Duration)." />
            <alias value="timing" />
            <min value="0" />
            <max value="1" />
            <base>
                <path value="ResearchStudy.period" />
                <min value="0" />
                <max value="1" />
            </base>
            <type>
                <code value="Period" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <constraint>
                <key value="per-1" />
                <severity value="error" />
                <human value="If present, start SHALL have a lower value than end" />
                <expression value="start.hasValue().not() or end.hasValue().not() or (start &lt;= end)" />
                <xpath value="not(exists(f:start/@value)) or not(exists(f:end/@value)) or (xs:dateTime(f:start/@value) &lt;= xs:dateTime(f:end/@value))" />
                <source value="http://hl7.org/fhir/StructureDefinition/Period" />
            </constraint>
            <isSummary value="true" />
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="v2" />
                <map value="DR" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value="IVL&lt;TS&gt;[lowClosed=&quot;true&quot; and highClosed=&quot;true&quot;] or URG&lt;TS&gt;[lowClosed=&quot;true&quot; and highClosed=&quot;true&quot;]" />
            </mapping>
            <mapping>
                <identity value="clinicaltrials-gov" />
                <map value="Study Start Date (start); Study Completion Date (end)" />
            </mapping>
            <mapping>
                <identity value="w5" />
                <map value="FiveWs.done[x]" />
            </mapping>
            <mapping>
                <identity value="BRIDG5.1" />
                <map value="ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value=".effectiveTime" />
            </mapping>
        </element>
        <element id="ResearchStudy.sponsor">
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
                <valueCode value="normative" />
            </extension>
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
                <valueCode value="4.0.0" />
            </extension>
            <path value="ResearchStudy.sponsor" />
            <short value="Organization that initiates and is legally responsible for the study" />
            <definition value="An organization that initiates the investigation and is legally responsible for the study." />
            <comment value="References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository." />
            <min value="0" />
            <max value="1" />
            <base>
                <path value="ResearchStudy.sponsor" />
                <min value="0" />
                <max value="1" />
            </base>
            <type>
                <code value="Reference" />
                <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <constraint>
                <key value="ref-1" />
                <severity value="error" />
                <human value="SHALL have a contained resource if a local reference is provided" />
                <expression value="reference.startsWith(&#39;#&#39;).not() or (reference.substring(1).trace(&#39;url&#39;) in %rootResource.contained.id.trace(&#39;ids&#39;))" />
                <xpath value="not(starts-with(f:reference/@value, &#39;#&#39;)) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, &#39;#&#39;)]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, &#39;#&#39;)])" />
                <source value="http://hl7.org/fhir/StructureDefinition/Reference" />
            </constraint>
            <isSummary value="true" />
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value="The target of a resource reference is a RIM entry point (Act, Role, or Entity)" />
            </mapping>
            <mapping>
                <identity value="clinicaltrials-gov" />
                <map value="Sponsor" />
            </mapping>
            <mapping>
                <identity value="w5" />
                <map value="FiveWs.actor" />
            </mapping>
            <mapping>
                <identity value="BRIDG5.1" />
                <map value="RegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value=".participation[typeCode=PRF].role[scoper.determinerCode=INSTANCE]" />
            </mapping>
        </element>
        <element id="ResearchStudy.principalInvestigator">
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
                <valueCode value="normative" />
            </extension>
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
                <valueCode value="4.0.0" />
            </extension>
            <path value="ResearchStudy.principalInvestigator" />
            <short value="Researcher who oversees multiple aspects of the study" />
            <definition value="A researcher in a study who oversees multiple aspects of the study, such as concept development, protocol writing, protocol submission for IRB approval, participant recruitment, informed consent, data collection, analysis, interpretation and presentation." />
            <comment value="References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository." />
            <min value="0" />
            <max value="1" />
            <base>
                <path value="ResearchStudy.principalInvestigator" />
                <min value="0" />
                <max value="1" />
            </base>
            <type>
                <code value="Reference" />
                <targetProfile value="http://hl7.org/fhir/StructureDefinition/Practitioner" />
                <targetProfile value="http://hl7.org/fhir/StructureDefinition/PractitionerRole" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <constraint>
                <key value="ref-1" />
                <severity value="error" />
                <human value="SHALL have a contained resource if a local reference is provided" />
                <expression value="reference.startsWith(&#39;#&#39;).not() or (reference.substring(1).trace(&#39;url&#39;) in %rootResource.contained.id.trace(&#39;ids&#39;))" />
                <xpath value="not(starts-with(f:reference/@value, &#39;#&#39;)) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, &#39;#&#39;)]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, &#39;#&#39;)])" />
                <source value="http://hl7.org/fhir/StructureDefinition/Reference" />
            </constraint>
            <isSummary value="true" />
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value="The target of a resource reference is a RIM entry point (Act, Role, or Entity)" />
            </mapping>
            <mapping>
                <identity value="clinicaltrials-gov" />
                <map value="Principal Investigator" />
            </mapping>
            <mapping>
                <identity value="w5" />
                <map value="FiveWs.actor" />
            </mapping>
            <mapping>
                <identity value="BRIDG5.1" />
                <map value="StudyInvestigator" />
            </mapping>
        </element>
        <element id="ResearchStudy.site">
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
                <valueCode value="normative" />
            </extension>
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
                <valueCode value="4.0.0" />
            </extension>
            <path value="ResearchStudy.site" />
            <short value="Facility where study activities are conducted" />
            <definition value="A facility in which study activities are conducted." />
            <comment value="References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository." />
            <min value="0" />
            <max value="*" />
            <base>
                <path value="ResearchStudy.site" />
                <min value="0" />
                <max value="*" />
            </base>
            <type>
                <code value="Reference" />
                <targetProfile value="http://hl7.org/fhir/StructureDefinition/Location" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <constraint>
                <key value="ref-1" />
                <severity value="error" />
                <human value="SHALL have a contained resource if a local reference is provided" />
                <expression value="reference.startsWith(&#39;#&#39;).not() or (reference.substring(1).trace(&#39;url&#39;) in %rootResource.contained.id.trace(&#39;ids&#39;))" />
                <xpath value="not(starts-with(f:reference/@value, &#39;#&#39;)) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, &#39;#&#39;)]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, &#39;#&#39;)])" />
                <source value="http://hl7.org/fhir/StructureDefinition/Reference" />
            </constraint>
            <isSummary value="true" />
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value="The target of a resource reference is a RIM entry point (Act, Role, or Entity)" />
            </mapping>
            <mapping>
                <identity value="clinicaltrials-gov" />
                <map value="Facility" />
            </mapping>
            <mapping>
                <identity value="w5" />
                <map value="FiveWs.where[x]" />
            </mapping>
            <mapping>
                <identity value="BRIDG5.1" />
                <map value="PlannedStudySite; StudySite" />
            </mapping>
        </element>
        <element id="ResearchStudy.reasonStopped">
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
                <valueCode value="normative" />
            </extension>
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
                <valueCode value="4.0.0" />
            </extension>
            <path value="ResearchStudy.reasonStopped" />
            <short value="accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design" />
            <definition value="A description and/or code explaining the premature termination of the study." />
            <comment value="Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination." />
            <min value="0" />
            <max value="1" />
            <base>
                <path value="ResearchStudy.reasonStopped" />
                <min value="0" />
                <max value="1" />
            </base>
            <type>
                <code value="CodeableConcept" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <isSummary value="true" />
            <binding>
                <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
                    <valueString value="ResearchStudyReasonStopped" />
                </extension>
                <strength value="example" />
                <description value="Codes for why the study ended prematurely." />
                <valueSet value="http://hl7.org/fhir/ValueSet/research-study-reason-stopped" />
            </binding>
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="v2" />
                <map value="CE/CNE/CWE" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value="CD" />
            </mapping>
            <mapping>
                <identity value="orim" />
                <map value="fhir:CodeableConcept rdfs:subClassOf dt:CD" />
            </mapping>
            <mapping>
                <identity value="clinicaltrials-gov" />
                <map value="Why Study Stopped" />
            </mapping>
            <mapping>
                <identity value="w5" />
                <map value="FiveWs.why[x]" />
            </mapping>
            <mapping>
                <identity value="BRIDG5.1" />
                <map value="StudyOverallStatus.studyStoppedReasonCode" />
            </mapping>
        </element>
        <element id="ResearchStudy.note">
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
                <valueCode value="normative" />
            </extension>
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
                <valueCode value="4.0.0" />
            </extension>
            <path value="ResearchStudy.note" />
            <short value="Comments made about the study" />
            <definition value="Comments made about the study by the performer, subject or other participants." />
            <comment value="For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time.  This element may need to be included in narrative because of the potential for modifying information.  *Annotations SHOULD NOT* be used to communicate &quot;modifying&quot; information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible)." />
            <min value="0" />
            <max value="*" />
            <base>
                <path value="ResearchStudy.note" />
                <min value="0" />
                <max value="*" />
            </base>
            <type>
                <code value="Annotation" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="v2" />
                <map value="N/A" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value="Act" />
            </mapping>
            <mapping>
                <identity value="BRIDG5.1" />
                <map value="No BRIDG mapping" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value=".inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]" />
            </mapping>
        </element>
        <element id="ResearchStudy.arm">
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
                <valueCode value="normative" />
            </extension>
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
                <valueCode value="4.0.0" />
            </extension>
            <path value="ResearchStudy.arm" />
            <short value="Defined path through the study for a subject" />
            <definition value="Describes an expected sequence of events for one of the participants of a study.  E.g. Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up." />
            <min value="0" />
            <max value="*" />
            <base>
                <path value="ResearchStudy.arm" />
                <min value="0" />
                <max value="*" />
            </base>
            <type>
                <code value="BackboneElement" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="clinicaltrials-gov" />
                <map value="Arms" />
            </mapping>
            <mapping>
                <identity value="BRIDG5.1" />
                <map value="Arm" />
            </mapping>
        </element>
        <element id="ResearchStudy.arm.id">
            <path value="ResearchStudy.arm.id" />
            <representation value="xmlAttr" />
            <short value="Unique id for inter-element referencing" />
            <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
            <min value="0" />
            <max value="1" />
            <base>
                <path value="Element.id" />
                <min value="0" />
                <max value="1" />
            </base>
            <type>
                <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
                    <valueUrl value="string" />
                </extension>
                <code value="http://hl7.org/fhirpath/System.String" />
            </type>
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
        </element>
        <element id="ResearchStudy.arm.extension">
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
                <valueCode value="normative" />
            </extension>
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
                <valueCode value="4.0.0" />
            </extension>
            <path value="ResearchStudy.arm.extension" />
            <slicing>
                <discriminator>
                    <type value="value" />
                    <path value="url" />
                </discriminator>
                <description value="Extensions are always sliced by (at least) url" />
                <rules value="open" />
            </slicing>
            <short value="Additional content defined by implementations" />
            <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." />
            <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
            <alias value="extensions" />
            <alias value="user content" />
            <min value="0" />
            <max value="*" />
            <base>
                <path value="Element.extension" />
                <min value="0" />
                <max value="*" />
            </base>
            <type>
                <code value="Extension" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <constraint>
                <key value="ext-1" />
                <severity value="error" />
                <human value="Must have either extensions or value[x], not both" />
                <expression value="extension.exists() != value.exists()" />
                <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &#39;value&#39;)])" />
                <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
            </constraint>
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value="N/A" />
            </mapping>
        </element>
        <element id="ResearchStudy.arm.modifierExtension">
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
                <valueCode value="normative" />
            </extension>
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
                <valueCode value="4.0.0" />
            </extension>
            <path value="ResearchStudy.arm.modifierExtension" />
            <short value="Extensions that cannot be ignored even if unrecognized" />
            <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element&#39;s descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." />
            <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
            <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension)." />
            <alias value="extensions" />
            <alias value="user content" />
            <alias value="modifiers" />
            <min value="0" />
            <max value="*" />
            <base>
                <path value="BackboneElement.modifierExtension" />
                <min value="0" />
                <max value="*" />
            </base>
            <type>
                <code value="Extension" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <constraint>
                <key value="ext-1" />
                <severity value="error" />
                <human value="Must have either extensions or value[x], not both" />
                <expression value="extension.exists() != value.exists()" />
                <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &#39;value&#39;)])" />
                <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
            </constraint>
            <isModifier value="true" />
            <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" />
            <isSummary value="true" />
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value="N/A" />
            </mapping>
        </element>
        <element id="ResearchStudy.arm.name">
            <path value="ResearchStudy.arm.name" />
            <short value="Label for study arm" />
            <definition value="Unique, human-readable label for this arm of the study." />
            <comment value="Note that FHIR strings SHALL NOT exceed 1MB in size" />
            <min value="1" />
            <max value="1" />
            <base>
                <path value="ResearchStudy.arm.name" />
                <min value="1" />
                <max value="1" />
            </base>
            <type>
                <code value="string" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="clinicaltrials-gov" />
                <map value="Arm Label" />
            </mapping>
            <mapping>
                <identity value="BRIDG5.1" />
                <map value="Arm.name" />
            </mapping>
        </element>
        <element id="ResearchStudy.arm.type">
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
                <valueCode value="normative" />
            </extension>
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
                <valueCode value="4.0.0" />
            </extension>
            <path value="ResearchStudy.arm.type" />
            <short value="Categorization of study arm" />
            <definition value="Categorization of study arm, e.g. experimental, active comparator, placebo comparater." />
            <comment value="Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination." />
            <min value="0" />
            <max value="1" />
            <base>
                <path value="ResearchStudy.arm.type" />
                <min value="0" />
                <max value="1" />
            </base>
            <type>
                <code value="CodeableConcept" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="v2" />
                <map value="CE/CNE/CWE" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value="CD" />
            </mapping>
            <mapping>
                <identity value="orim" />
                <map value="fhir:CodeableConcept rdfs:subClassOf dt:CD" />
            </mapping>
            <mapping>
                <identity value="clinicaltrials-gov" />
                <map value="Arm Type" />
            </mapping>
            <mapping>
                <identity value="BRIDG5.1" />
                <map value="Arm.typeCode" />
            </mapping>
        </element>
        <element id="ResearchStudy.arm.description">
            <path value="ResearchStudy.arm.description" />
            <short value="Short explanation of study path" />
            <definition value="A succinct description of the path through the study that would be followed by a subject adhering to this arm." />
            <comment value="Note that FHIR strings SHALL NOT exceed 1MB in size" />
            <min value="0" />
            <max value="1" />
            <base>
                <path value="ResearchStudy.arm.description" />
                <min value="0" />
                <max value="1" />
            </base>
            <type>
                <code value="string" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="clinicaltrials-gov" />
                <map value="Arm Description" />
            </mapping>
            <mapping>
                <identity value="BRIDG5.1" />
                <map value="Arm.description" />
            </mapping>
        </element>
        <element id="ResearchStudy.objective">
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
                <valueCode value="normative" />
            </extension>
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
                <valueCode value="4.0.0" />
            </extension>
            <path value="ResearchStudy.objective" />
            <short value="A goal for the study" />
            <definition value="A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study." />
            <min value="0" />
            <max value="*" />
            <base>
                <path value="ResearchStudy.objective" />
                <min value="0" />
                <max value="*" />
            </base>
            <type>
                <code value="BackboneElement" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="BRIDG5.1" />
                <map value="StudyObjective" />
            </mapping>
        </element>
        <element id="ResearchStudy.objective.id">
            <path value="ResearchStudy.objective.id" />
            <representation value="xmlAttr" />
            <short value="Unique id for inter-element referencing" />
            <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
            <min value="0" />
            <max value="1" />
            <base>
                <path value="Element.id" />
                <min value="0" />
                <max value="1" />
            </base>
            <type>
                <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
                    <valueUrl value="string" />
                </extension>
                <code value="http://hl7.org/fhirpath/System.String" />
            </type>
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
        </element>
        <element id="ResearchStudy.objective.extension">
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
                <valueCode value="normative" />
            </extension>
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
                <valueCode value="4.0.0" />
            </extension>
            <path value="ResearchStudy.objective.extension" />
            <slicing>
                <discriminator>
                    <type value="value" />
                    <path value="url" />
                </discriminator>
                <description value="Extensions are always sliced by (at least) url" />
                <rules value="open" />
            </slicing>
            <short value="Additional content defined by implementations" />
            <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." />
            <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
            <alias value="extensions" />
            <alias value="user content" />
            <min value="0" />
            <max value="*" />
            <base>
                <path value="Element.extension" />
                <min value="0" />
                <max value="*" />
            </base>
            <type>
                <code value="Extension" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <constraint>
                <key value="ext-1" />
                <severity value="error" />
                <human value="Must have either extensions or value[x], not both" />
                <expression value="extension.exists() != value.exists()" />
                <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &#39;value&#39;)])" />
                <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
            </constraint>
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value="N/A" />
            </mapping>
        </element>
        <element id="ResearchStudy.objective.modifierExtension">
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
                <valueCode value="normative" />
            </extension>
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
                <valueCode value="4.0.0" />
            </extension>
            <path value="ResearchStudy.objective.modifierExtension" />
            <short value="Extensions that cannot be ignored even if unrecognized" />
            <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element&#39;s descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." />
            <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
            <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension)." />
            <alias value="extensions" />
            <alias value="user content" />
            <alias value="modifiers" />
            <min value="0" />
            <max value="*" />
            <base>
                <path value="BackboneElement.modifierExtension" />
                <min value="0" />
                <max value="*" />
            </base>
            <type>
                <code value="Extension" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <constraint>
                <key value="ext-1" />
                <severity value="error" />
                <human value="Must have either extensions or value[x], not both" />
                <expression value="extension.exists() != value.exists()" />
                <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &#39;value&#39;)])" />
                <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
            </constraint>
            <isModifier value="true" />
            <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" />
            <isSummary value="true" />
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value="N/A" />
            </mapping>
        </element>
        <element id="ResearchStudy.objective.name">
            <path value="ResearchStudy.objective.name" />
            <short value="Label for the objective" />
            <definition value="Unique, human-readable label for this objective of the study." />
            <comment value="Note that FHIR strings SHALL NOT exceed 1MB in size" />
            <min value="0" />
            <max value="1" />
            <base>
                <path value="ResearchStudy.objective.name" />
                <min value="0" />
                <max value="1" />
            </base>
            <type>
                <code value="string" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="BRIDG5.1" />
                <map value="No BRIDG mapping (BRIDG has a description, but not a name)" />
            </mapping>
        </element>
        <element id="ResearchStudy.objective.type">
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
                <valueCode value="normative" />
            </extension>
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
                <valueCode value="4.0.0" />
            </extension>
            <path value="ResearchStudy.objective.type" />
            <short value="primary | secondary | exploratory" />
            <definition value="The kind of study objective." />
            <comment value="Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination." />
            <min value="0" />
            <max value="1" />
            <base>
                <path value="ResearchStudy.objective.type" />
                <min value="0" />
                <max value="1" />
            </base>
            <type>
                <code value="CodeableConcept" />
            </type>
            <condition value="ele-1" />
            <constraint>
                <key value="ele-1" />
                <severity value="error" />
                <human value="All FHIR elements must have a @value or children" />
                <expression value="hasValue() or (children().count() &gt; id.count())" />
                <xpath value="@value|f:*|h:div" />
                <source value="http://hl7.org/fhir/StructureDefinition/Element" />
            </constraint>
            <binding>
                <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
                    <valueString value="ResearchStudyObjectiveType" />
                </extension>
                <strength value="preferred" />
                <description value="Codes for the kind of study objective." />
                <valueSet value="http://hl7.org/fhir/ValueSet/research-study-objective-type" />
            </binding>
            <mapping>
                <identity value="rim" />
                <map value="n/a" />
            </mapping>
            <mapping>
                <identity value="v2" />
                <map value="CE/CNE/CWE" />
            </mapping>
            <mapping>
                <identity value="rim" />
                <map value="CD" />
            </mapping>
            <mapping>
                <identity value="orim" />
                <map value="fhir:CodeableConcept rdfs:subClassOf dt:CD" />
            </mapping>
            <mapping>
                <identity value="BRIDG5.1" />
                <map value="StudyObjective.typeCode" />
            </mapping>
        </element>
    </snapshot>
    <differential>
        <element id="ResearchStudy.status">
            <path value="ResearchStudy.status" />
            <fixedCode value="active" />
        </element>
        <element id="ResearchStudy.condition">
            <path value="ResearchStudy.condition" />
            <min value="1" />
            <binding>
                <strength value="required" />
                <description value="The name of an FRB Audit Group." />
                <valueSet value="https://frbresearch.org/fhir/ValueSet/ssr-research-studies" />
            </binding>
        </element>
        <element id="ResearchStudy.condition.coding">
            <path value="ResearchStudy.condition.coding" />
            <min value="1" />
        </element>
        <element id="ResearchStudy.condition.coding.code">
            <path value="ResearchStudy.condition.coding.code" />
            <min value="1" />
        </element>
    </differential>
</StructureDefinition>

ResearchStudy
Definition	A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques. A ResearchStudy involves the gathering of information about human or animal subjects.
Cardinality	0...*
Alias	Clinical Trial, Study
Comments	Need to make sure we encompass public health studies.
Invariants	dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources `contained.contained.empty()` dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource `contained.where((('#'+id in (%resource.descendants().reference \| %resource.descendants().as(canonical) \| %resource.descendants().as(uri) \| %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()` dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated `contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()` dom-5: If a resource is contained in another resource, it SHALL NOT have a security label `contained.meta.security.empty()` dom-6: A resource should have narrative for robust management text.`div`.exists()
Mappings	rim: Entity. Role, or Act BRIDG5.1: ObservationalStudyProtocolVersion; Study; StudyProtocolVersion v2: OBX rim: Observation[classCode=CLNTRL, moodCode=EVN]
ResearchStudy.id
Definition	The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
Cardinality	0...1
Type	string
Summary	True
Comments	The only time that a resource does not have an id is when it is being submitted to the server using a create operation.
ResearchStudy.meta
Definition	The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.
Cardinality	0...1
Type	Meta
Summary	True
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
ResearchStudy.implicitRules
Definition	A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.
Cardinality	0...1
Type	uri
Modifier	True
Summary	True
Comments	Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
ResearchStudy.language
Definition	The base language in which the resource is written.
Cardinality	0...1
Type	code
Binding	A human language. CommonLanguages (preferred)
Comments	Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
ResearchStudy.text
Definition	A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.
Cardinality	0...1
Type	Narrative
Alias	narrative, html, xhtml, display
Comments	Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	rim: Act.text?
ResearchStudy.contained
Definition	These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.
Cardinality	0...*
Type	Resource
Alias	inline resources, anonymous resources, contained resources
Comments	This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.
Mappings	rim: N/A
ResearchStudy.extension
Definition	May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Cardinality	0...*
Type	Extension
Alias	extensions, user content
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()`
Mappings	rim: N/A
ResearchStudy.modifierExtension
Definition	May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Cardinality	0...*
Type	Extension
Modifier	True
Alias	extensions, user content
Requirements	Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()`
Mappings	rim: N/A
ResearchStudy.identifier
Definition	Identifiers assigned to this research study by the sponsor or other systems.
Cardinality	0...*
Type	Identifier
Summary	True
Requirements	Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	clinicaltrials-gov: Organization's Unique Protocol ID; Secondary IDs w5: FiveWs.identifier BRIDG5.1: No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic) rim: .identifier
ResearchStudy.title
Definition	A short, descriptive user-friendly label for the study.
Cardinality	0...1
Type	string
Summary	True
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	clinicaltrials-gov: Brief Title BRIDG5.1: No BRIDG mapping (although there is StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)
ResearchStudy.protocol
Definition	The set of steps expected to be performed as part of the execution of the study.
Cardinality	0...*
Type	Reference(PlanDefinition)
Summary	True
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	clinicaltrials-gov: Interventions; Arm/Intervention Cross-Reference BRIDG5.1: StudyProtocolDocumentVersionPublicTitle.name rim: .outboundRelationship[typeCode=DEFN].target
ResearchStudy.partOf
Definition	A larger research study of which this particular study is a component or step.
Cardinality	0...*
Type	Reference(ResearchStudy)
Summary	True
Alias	container
Requirements	Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc.
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	BRIDG5.1: CompanionStudyRelationship rim: .inboundRelationship[typeCode=COMP].source[moodCode=EVN]
ResearchStudy.status
Definition	The current state of the study.
Cardinality	1...1
Type	code
Binding	Codes that convey the current status of the research study. ResearchStudyStatus (required)
Modifier	True
Summary	True
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Fixed Value	active
Mappings	w5: FiveWs.status BRIDG5.1: StudyOverallStatus.code rim: .status
ResearchStudy.primaryPurposeType
Definition	The type of study based upon the intent of the study's activities. A classification of the intent of the study.
Cardinality	0...1
Type	CodeableConcept
Binding	Codes for the main intent of the study. ResearchStudyPrimaryPurposeType (extensible)
Summary	True
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	BRIDG5.1: StudyProtocolVersion.primaryPurposeTypeCode
ResearchStudy.phase
Definition	The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
Cardinality	0...1
Type	CodeableConcept
Binding	Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation. ResearchStudyPhase (example)
Summary	True
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	clinicaltrials-gov: Study Phase BRIDG5.1: StudyProtocolVersion.phaseCode
ResearchStudy.category
Definition	Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.
Cardinality	0...*
Type	CodeableConcept
Binding	Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc. (unbound) (example)
Summary	True
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	clinicaltrials-gov: Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention BRIDG5.1: InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode
ResearchStudy.focus
Definition	The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about.
Cardinality	0...*
Type	CodeableConcept
Binding	Codes for medications, devices and other interventions. (unbound) (example)
Summary	True
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	clinicaltrials-gov: Focus of Study w5: FiveWs.what[x] BRIDG5.1: InterventionalStudyProtocol.interventionTypeCode
ResearchStudy.condition
Definition	The condition that is the focus of the study. For example, In a study to examine risk factors for Lupus, might have as an inclusion criterion "healthy volunteer", but the target condition code would be a Lupus SNOMED code.
Cardinality	1...*
Type	CodeableConcept
Binding	The name of an FRB Audit Group. ssr-research-studies (required)
Summary	True
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	clinicaltrials-gov: Conditions w5: FiveWs.what[x] BRIDG5.1: StudyCondition.code
ResearchStudy.condition.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Cardinality	0...1
Type	string
Mappings	rim: n/a
ResearchStudy.condition.extension
Definition	May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Cardinality	0...*
Type	Extension
Alias	extensions, user content
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Slicing	Unordered, Open, by url(Value)
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()`
Mappings	rim: n/a
ResearchStudy.condition.coding
Definition	A reference to a code defined by a terminology system.
Cardinality	1...*
Type	Coding
Summary	True
Requirements	Allows for alternative encodings within a code system, and translations to other code systems.
Comments	Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
ResearchStudy.condition.coding.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Cardinality	0...1
Type	string
Mappings	rim: n/a
ResearchStudy.condition.coding.extension
Definition	May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Cardinality	0...*
Type	Extension
Alias	extensions, user content
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Slicing	Unordered, Open, by url(Value)
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()`
Mappings	rim: n/a
ResearchStudy.condition.coding.system
Definition	The identification of the code system that defines the meaning of the symbol in the code.
Cardinality	0...1
Type	uri
Summary	True
Requirements	Need to be unambiguous about the source of the definition of the symbol.
Comments	The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	v2: CE.3 rim:* ./codeSystem orim: fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
ResearchStudy.condition.coding.version
Definition	The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.
Cardinality	0...1
Type	string
Summary	True
Comments	Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	v2: CE.7 rim:* ./codeSystemVersion orim: fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
ResearchStudy.condition.coding.code
Definition	A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).
Cardinality	1...1
Type	code
Summary	True
Requirements	Need to refer to a particular code in the system.
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	v2: CE.1 rim:* ./code orim: fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
ResearchStudy.condition.coding.display
Definition	A representation of the meaning of the code in the system, following the rules of the system.
Cardinality	0...1
Type	string
Summary	True
Requirements	Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	v2: CE.2 - but note this is not well followed rim:* CV.displayName orim: fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
ResearchStudy.condition.coding.userSelected
Definition	Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Cardinality	0...1
Type	boolean
Summary	True
Requirements	This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.
Comments	Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	v2: Sometimes implied by being first rim: CD.codingRationale orim: fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
ResearchStudy.condition.text
Definition	A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.
Cardinality	0...1
Type	string
Summary	True
Requirements	The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.
Comments	Very often the text is the same as a displayName of one of the codings.
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
ResearchStudy.contact
Definition	Contact details to assist a user in learning more about or engaging with the study.
Cardinality	0...*
Type	ContactDetail
Summary	True
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	clinicaltrials-gov: Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators BRIDG5.1: PointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVersion
ResearchStudy.relatedArtifact
Definition	Citations, references and other related documents.
Cardinality	0...*
Type	RelatedArtifact
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	clinicaltrials-gov: Citations, Links, Available Study Data/Documents BRIDG5.1: StudyProtocolDocument, StudyProtocolDocumentVersion
ResearchStudy.keyword
Definition	Key terms to aid in searching for or filtering the study.
Cardinality	0...*
Type	CodeableConcept
Binding	Words associated with the study that may be useful in discovery. (unbound) (example)
Summary	True
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	clinicaltrials-gov: Keywords BRIDG5.1: DocumentVersion.keywordCode; DocumentVersion.keywordText
ResearchStudy.location
Definition	Indicates a country, state or other region where the study is taking place.
Cardinality	0...*
Type	CodeableConcept
Binding	Countries and regions within which this artifact is targeted for use. Jurisdiction ValueSet (extensible)
Summary	True
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	BRIDG5.1: StudyProtocolVersion.participatingLocationCode
ResearchStudy.description
Definition	A full description of how the study is being conducted.
Cardinality	0...1
Type	markdown
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	clinicaltrials-gov: Detailed Description BRIDG5.1: StudyProtocolDocumentVersion.publicDescription
ResearchStudy.enrollment
Definition	Reference to a Group that defines the criteria for and quantity of subjects participating in the study. E.g. " 200 female Europeans between the ages of 20 and 45 with early onset diabetes".
Cardinality	0...*
Type	Reference(Group)
Summary	True
Alias	patient
Comments	The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource.
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	clinicaltrials-gov: Enrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria) w5: FiveWs.subject[x] BRIDG5.1: InterventionalStudyProtocol.interventionGroupQuantity rim: .participation[typeCode=SBJ].role w5: FiveWs.subject
ResearchStudy.period
Definition	Identifies the start date and the expected (or actual, depending on status) end date for the study.
Cardinality	0...1
Type	Period
Summary	True
Alias	timing
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	clinicaltrials-gov: Study Start Date (start); Study Completion Date (end) w5: FiveWs.done[x] BRIDG5.1: ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration rim: .effectiveTime
ResearchStudy.sponsor
Definition	An organization that initiates the investigation and is legally responsible for the study.
Cardinality	0...1
Type	Reference(Organization)
Summary	True
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	clinicaltrials-gov: Sponsor w5: FiveWs.actor BRIDG5.1: RegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode rim: .participation[typeCode=PRF].role[scoper.determinerCode=INSTANCE]
ResearchStudy.principalInvestigator
Definition	A researcher in a study who oversees multiple aspects of the study, such as concept development, protocol writing, protocol submission for IRB approval, participant recruitment, informed consent, data collection, analysis, interpretation and presentation.
Cardinality	0...1
Type	Reference(Practitioner \| PractitionerRole)
Summary	True
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	clinicaltrials-gov: Principal Investigator w5: FiveWs.actor BRIDG5.1: StudyInvestigator
ResearchStudy.site
Definition	A facility in which study activities are conducted.
Cardinality	0...*
Type	Reference(Location)
Summary	True
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	clinicaltrials-gov: Facility w5: FiveWs.where[x] BRIDG5.1: PlannedStudySite; StudySite
ResearchStudy.reasonStopped
Definition	A description and/or code explaining the premature termination of the study.
Cardinality	0...1
Type	CodeableConcept
Binding	Codes for why the study ended prematurely. ResearchStudyReasonStopped (example)
Summary	True
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	clinicaltrials-gov: Why Study Stopped w5: FiveWs.why[x] BRIDG5.1: StudyOverallStatus.studyStoppedReasonCode
ResearchStudy.note
Definition	Comments made about the study by the performer, subject or other participants.
Cardinality	0...*
Type	Annotation
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	BRIDG5.1: No BRIDG mapping rim: .inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]
ResearchStudy.arm
Definition	Describes an expected sequence of events for one of the participants of a study. E.g. Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up.
Cardinality	0...*
Type	BackboneElement
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	clinicaltrials-gov: Arms BRIDG5.1: Arm
ResearchStudy.arm.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Cardinality	0...1
Type	string
Mappings	rim: n/a
ResearchStudy.arm.extension
Definition	May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Cardinality	0...*
Type	Extension
Alias	extensions, user content
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()`
Mappings	rim: n/a
ResearchStudy.arm.modifierExtension
Definition	May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Cardinality	0...*
Type	Extension
Modifier	True
Summary	True
Alias	extensions, user content, modifiers
Requirements	Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()`
Mappings	rim: N/A
ResearchStudy.arm.name
Definition	Unique, human-readable label for this arm of the study.
Cardinality	1...1
Type	string
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	clinicaltrials-gov: Arm Label BRIDG5.1: Arm.name
ResearchStudy.arm.type
Definition	Categorization of study arm, e.g. experimental, active comparator, placebo comparater.
Cardinality	0...1
Type	CodeableConcept
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	clinicaltrials-gov: Arm Type BRIDG5.1: Arm.typeCode
ResearchStudy.arm.description
Definition	A succinct description of the path through the study that would be followed by a subject adhering to this arm.
Cardinality	0...1
Type	string
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	clinicaltrials-gov: Arm Description BRIDG5.1: Arm.description
ResearchStudy.objective
Definition	A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study.
Cardinality	0...*
Type	BackboneElement
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	BRIDG5.1: StudyObjective
ResearchStudy.objective.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Cardinality	0...1
Type	string
Mappings	rim: n/a
ResearchStudy.objective.extension
Definition	May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Cardinality	0...*
Type	Extension
Alias	extensions, user content
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()`
Mappings	rim: n/a
ResearchStudy.objective.modifierExtension
Definition	May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Cardinality	0...*
Type	Extension
Modifier	True
Summary	True
Alias	extensions, user content, modifiers
Requirements	Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()`
Mappings	rim: N/A
ResearchStudy.objective.name
Definition	Unique, human-readable label for this objective of the study.
Cardinality	0...1
Type	string
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	BRIDG5.1: No BRIDG mapping (BRIDG has a description, but not a name)
ResearchStudy.objective.type
Definition	The kind of study objective.
Cardinality	0...1
Type	CodeableConcept
Binding	Codes for the kind of study objective. ResearchStudyObjectiveType (preferred)
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	BRIDG5.1: StudyObjective.typeCode

ResearchStudy		0..*
ResearchStudy.id	string	0..1
ResearchStudy.meta	Meta	0..1
ResearchStudy.implicitRules	uri	0..1
ResearchStudy.language	code	0..1
ResearchStudy.text	Narrative	0..1
ResearchStudy.contained	Resource	0..*
ResearchStudy.extension	Extension	0..*
ResearchStudy.modifierExtension	Extension	0..*
ResearchStudy.identifier	Identifier	0..*
ResearchStudy.title	string	0..1
ResearchStudy.protocol	Reference(PlanDefinition)	0..*
ResearchStudy.partOf	Reference(ResearchStudy)	0..*
ResearchStudy.status	code	1..1
ResearchStudy.primaryPurposeType	CodeableConcept	0..1
ResearchStudy.phase	CodeableConcept	0..1
ResearchStudy.category	CodeableConcept	0..*
ResearchStudy.focus	CodeableConcept	0..*
ResearchStudy.condition	CodeableConcept	1..*
ResearchStudy.condition.id	string	0..1
ResearchStudy.condition.extension	Extension	0..*
ResearchStudy.condition.coding	Coding	1..*
ResearchStudy.condition.coding.id	string	0..1
ResearchStudy.condition.coding.extension	Extension	0..*
ResearchStudy.condition.coding.system	uri	0..1
ResearchStudy.condition.coding.version	string	0..1
ResearchStudy.condition.coding.code	code	1..1
ResearchStudy.condition.coding.display	string	0..1
ResearchStudy.condition.coding.userSelected	boolean	0..1
ResearchStudy.condition.text	string	0..1
ResearchStudy.contact	ContactDetail	0..*
ResearchStudy.relatedArtifact	RelatedArtifact	0..*
ResearchStudy.keyword	CodeableConcept	0..*
ResearchStudy.location	CodeableConcept	0..*
ResearchStudy.description	markdown	0..1
ResearchStudy.enrollment	Reference(Group)	0..*
ResearchStudy.period	Period	0..1
ResearchStudy.sponsor	Reference(Organization)	0..1
ResearchStudy.principalInvestigator	Reference(Practitioner \| PractitionerRole)	0..1
ResearchStudy.site	Reference(Location)	0..*
ResearchStudy.reasonStopped	CodeableConcept	0..1
ResearchStudy.note	Annotation	0..*
ResearchStudy.arm	BackboneElement	0..*
ResearchStudy.arm.id	string	0..1
ResearchStudy.arm.extension	Extension	0..*
ResearchStudy.arm.modifierExtension	Extension	0..*
ResearchStudy.arm.name	string	1..1
ResearchStudy.arm.type	CodeableConcept	0..1
ResearchStudy.arm.description	string	0..1
ResearchStudy.objective	BackboneElement	0..*
ResearchStudy.objective.id	string	0..1
ResearchStudy.objective.extension	Extension	0..*
ResearchStudy.objective.modifierExtension	Extension	0..*
ResearchStudy.objective.name	string	0..1
ResearchStudy.objective.type	CodeableConcept	0..1