HL7 FHIR® CareConnect Baseline Profiles for STU3 (Draft Standard for Trial Use)

Important Announcement regarding CareConnect STU3

As of 19/09/2023, CareConnect has been deprecated and all development on the CareConnect FHIR assets has ceased.
Therefore, vendors looking to start new implementations or looking to update existing implementations should use UK Core R4 based solutions. Vendors continuing to implement CareConnect based solutions do so at their own risk and on the understanding that no maintenance or support will be available.

StructureDefinition-CareConnect-ResearchStudy

A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge.

Snapshot View

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-1: If the resource is contained in another resource, it SHALL NOT contain any narrative `contained.text.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-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource `contained.where(('#'+id in %resource.descendants().reference).not()).empty()` Mappings rim: Entity. Role, or Act v2: OBX rim: Observation[classCode=CLNTRL, moodCode=EVN] w5: clinical.diagnostics
id	Σ	0..1	id	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 id Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a
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 may 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() \| (children().count() > id.count())` Mappings rim: n/a rim: N/A
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. 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. This element is labelled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a
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. Common Languages (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a
text	I	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 may 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 in formation is added later. Data type Narrative Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a rim: N/A 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. Data type Resource Mappings rim: Entity. Role, or Act 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. In order 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. 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() \| (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a 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. Usually modifier elements provide negation or qualification. In order 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. 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() \| (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a 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() \| (children().count() > id.count())` Mappings rim: n/a v2: CX / EI (occasionally, more often EI maps to a resource id or a URL) rim: II - see see identifier pattern at http://wiki.hl7.org/index.php?title=Common_Design_Patterns#Identifier_Pattern for relevant discussion. 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] servd: Identifier clinicaltrials-gov: Organization's Unique Protocol ID; Secondary IDs rim: .identifier w5: id
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.identifier.id Short description xml:id (or equivalent in JSON) Definition unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Comments Note that FHIR strings may not exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.identifier.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. In order 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. 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() \| (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
use	Σ ?!	0..1	codeBinding	There are no (further) constraints on this element Element id ResearchStudy.identifier.use Short description usual \| official \| temp \| secondary (If known) Definition The purpose of this identifier. Requirements Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. Comments This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. Data type code Binding Identifies the purpose for this identifier, if known . IdentifierUse (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Role.code or implied by context
type	Σ	0..1	CodeableConceptBinding	There are no (further) constraints on this element Element id ResearchStudy.identifier.type Short description Description of identifier Definition A coded type for the identifier that can be used to determine which identifier to use for a specific purpose. Requirements Allows users to make use of identifiers when the identifier system is not known. Comments This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type. Data type CodeableConcept Binding A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. Identifier Type Codes (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD v2: CX.5 rim: Role.code or implied by context
system	Σ	0..1	uri	There are no (further) constraints on this element Element id ResearchStudy.identifier.system Short description The namespace for the identifier value Definition Establishes the namespace for the value - that is, a URL that describes a set values that are unique. Requirements There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers. Comments see http://en.wikipedia.org/wiki/Uniform_resource_identifier Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Examples General http://www.acme.com/identifiers/patient Mappings rim: n/a v2: CX.4 / EI-2-4 rim: II.root or Role.id.root servd: ./IdentifierType
value	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.identifier.value Short description The value that is unique Definition The portion of the identifier typically relevant to the user and which is unique within the context of the system. Comments If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Examples General 123456 Mappings rim: n/a v2: CX.1 / EI.1 rim: II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root) servd: ./Value
period	Σ I	0..1	Period	There are no (further) constraints on this element Element id ResearchStudy.identifier.period Short description Time period when id is/was valid for use Definition Time period during which identifier is/was valid for use. Comments This is not a duration - that's a measure of time (a separate type), but a duration that occurs at a fixed value of time. 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"). If duration is required, specify the type as Interval\|Duration. Data type Period Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` per-1: If present, start SHALL have a lower value than end `start.empty() or end.empty() or (start <= end)` Mappings rim: n/a v2: DR rim: IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"] v2: CX.7 + CX.8 rim: Role.effectiveTime or implied by context servd: ./StartDate and ./EndDate
assigner	Σ I	0..1	Reference(CareConnect-Organization-1)	Element id ResearchStudy.identifier.assigner Short description Organization that issued id (may be just text) Definition Organization that issued/manages the identifier. Comments The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization. Data type Reference(CareConnect-Organization-1) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) v2: CX.4 / (CX.4,CX.9,CX.10) rim: II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper servd: ./IdentifierIssuingAuthority
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. Comments Note that FHIR strings may not exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a clinicaltrials-gov: Brief Title
protocol	Σ I	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. Comments 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. Data type Reference(PlanDefinition) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) clinicaltrials-gov: Interventions; Arm/Intervention Cross-Reference rim: .outboundRelationship[typeCode=DEFN].target
partOf	Σ I	0..*	Reference(CareConnect-ResearchStudy-1)	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. Comments 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. Data type Reference(CareConnect-ResearchStudy-1) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) rim: .inboundRelationship[typeCode=COMP].source[moodCode=EVN]
status	Σ ?!	1..1	codeBinding	There are no (further) constraints on this element Element id ResearchStudy.status Short description draft \| in-progress \| suspended \| stopped \| completed \| entered-in-error Definition The current state of the study. Comments This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid. 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() \| (children().count() > id.count())` Mappings rim: n/a rim: .status w5: status
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. Comments 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. 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() \| (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD clinicaltrials-gov: Study Type; Primary Purpose; Study Phase; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention
focus	Σ	0..*	CodeableConcept	There are no (further) constraints on this element Element id ResearchStudy.focus Short description Drugs, devices, conditions, etc. under study Definition The condition(s), medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about. Comments 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. Data type CodeableConcept Binding Codes for medications, devices, conditions and other interventions (unbound) (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD clinicaltrials-gov: Conditions or Focus of Study w5: what
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() \| (children().count() > id.count())` Mappings rim: n/a clinicaltrials-gov: Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators
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. Comments Each related artifact is either an attachment, or a reference to another knowledge resource, but not both. Data type RelatedArtifact Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a clinicaltrials-gov: Citations, Links, Available Study Data/Documents
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. Comments 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. 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() \| (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD clinicaltrials-gov: Keywords
jurisdiction	Σ	0..*	CodeableConceptBinding	There are no (further) constraints on this element Element id ResearchStudy.jurisdiction Short description Geographic region(s) for study Definition Indicates a country, state or other region where the study is taking place. Comments 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. 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() \| (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
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. Comments Systems are not required to have markdown support, and there is considerable variation in markdown syntax, so the text should be readable without markdown processing. The preferred markdown syntax is described here: http://daringfireball.net/projects/markdown/syntax (and tests here: http://daringfireball.net/projects/downloads/MarkdownTest_1.0.zip) Data type markdown Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a clinicaltrials-gov: Detailed Description
enrollment	Σ I	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() \| (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) 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: who.focus
period	Σ I	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. Requirements [The list of types may be constrained as appropriate for the type of event]. Comments This is not a duration - that's a measure of time (a separate type), but a duration that occurs at a fixed value of time. 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"). If duration is required, specify the type as Interval\|Duration. Data type Period Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` per-1: If present, start SHALL have a lower value than end `start.empty() or end.empty() or (start <= end)` Mappings rim: n/a v2: DR rim: IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"] clinicaltrials-gov: Study Start Date (start); Study Completion Date (end) w5: when.done
sponsor	Σ I	0..1	Reference(CareConnect-Organization-1)	Element id ResearchStudy.sponsor Short description Organization responsible for the study Definition The organization responsible for the execution of the study. Comments 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. Data type Reference(CareConnect-Organization-1) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) clinicaltrials-gov: Sponsor w5: who.actor
principalInvestigator	Σ I	0..1	Reference(CareConnect-Practitioner-1)	Element id ResearchStudy.principalInvestigator Short description The individual responsible for the study Definition Indicates the individual who has primary oversite of the execution of the study. Comments 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. Data type Reference(CareConnect-Practitioner-1) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) clinicaltrials-gov: Principal Investigator w5: who.actor
site	Σ I	0..*	Reference(CareConnect-Location-1)	Element id ResearchStudy.site Short description Location involved in study execution Definition Clinic, hospital or other healthcare location that is participating in the study. Comments 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. Data type Reference(CareConnect-Location-1) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) clinicaltrials-gov: Facility w5: where
reasonStopped	Σ	0..1	CodeableConcept	There are no (further) constraints on this element Element id ResearchStudy.reasonStopped Short description Reason for terminating study early Definition A description and/or code explaining the premature termination of the study. Comments 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. Data type CodeableConcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD clinicaltrials-gov: Why Study Stopped w5: why
note		0..*	Annotation	There are no (further) constraints on this element Element id ResearchStudy.note Short description Comments made about the event Definition Comments made about the event by the performer, subject or other participants. Comments 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). Data type Annotation Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.note.id Short description xml:id (or equivalent in JSON) Definition unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Comments Note that FHIR strings may not exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.note.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. In order 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. 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() \| (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
author[x]	Σ	0..1		There are no (further) constraints on this element Element id ResearchStudy.note.author[x] Short description Individual responsible for the annotation Definition The individual responsible for making the annotation. Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act.participant[typeCode=AUT].role
authorString			string	Data type string
authorReference			Reference(CareConnect-Patient-1 \| CareConnect-Practitioner-1 \| CareConnect-RelatedPerson-1)	Data type Reference(CareConnect-Patient-1 \| CareConnect-Practitioner-1 \| CareConnect-RelatedPerson-1)
time	Σ	0..1	dateTime	There are no (further) constraints on this element Element id ResearchStudy.note.time Short description When the annotation was made Definition Indicates when this particular annotation was made. Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act.effectiveTime
text		1..1	string	There are no (further) constraints on this element Element id ResearchStudy.note.text Short description The annotation - text content Definition The text of the annotation. Comments Note that FHIR strings may not exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act.text
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() \| (children().count() > id.count())` Mappings rim: n/a clinicaltrials-gov: Arms
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.arm.id Short description xml:id (or equivalent in JSON) Definition unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Comments Note that FHIR strings may not exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` 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. In order 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. 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() \| (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a 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 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 that contains it. Usually modifier elements provide negation or qualification. In order 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. 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() \| (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a 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. Comments Note that FHIR strings may not exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a clinicaltrials-gov: Arm Label
code		0..1	CodeableConcept	There are no (further) constraints on this element Element id ResearchStudy.arm.code Short description Categorization of study arm Definition Categorization of study arm, e.g. experimental, active comparator, placebo comparater. Comments 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. Data type CodeableConcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD clinicaltrials-gov: Arm Type
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. Comments Note that FHIR strings may not exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a clinicaltrials-gov: Arm Description

Differential View

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-1: If the resource is contained in another resource, it SHALL NOT contain any narrative `contained.text.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-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource `contained.where(('#'+id in %resource.descendants().reference).not()).empty()` Mappings rim: Entity. Role, or Act v2: OBX rim: Observation[classCode=CLNTRL, moodCode=EVN] w5: clinical.diagnostics
id	Σ	0..1	id	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 id Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a
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 may 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() \| (children().count() > id.count())` Mappings rim: n/a rim: N/A
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. 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. This element is labelled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a
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. Common Languages (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a
text	I	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 may 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 in formation is added later. Data type Narrative Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a rim: N/A 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. Data type Resource Mappings rim: Entity. Role, or Act 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. In order 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. 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() \| (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a 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. Usually modifier elements provide negation or qualification. In order 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. 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() \| (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a 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() \| (children().count() > id.count())` Mappings rim: n/a v2: CX / EI (occasionally, more often EI maps to a resource id or a URL) rim: II - see see identifier pattern at http://wiki.hl7.org/index.php?title=Common_Design_Patterns#Identifier_Pattern for relevant discussion. 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] servd: Identifier clinicaltrials-gov: Organization's Unique Protocol ID; Secondary IDs rim: .identifier w5: id
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.identifier.id Short description xml:id (or equivalent in JSON) Definition unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Comments Note that FHIR strings may not exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.identifier.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. In order 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. 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() \| (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
use	Σ ?!	0..1	codeBinding	There are no (further) constraints on this element Element id ResearchStudy.identifier.use Short description usual \| official \| temp \| secondary (If known) Definition The purpose of this identifier. Requirements Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. Comments This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. Data type code Binding Identifies the purpose for this identifier, if known . IdentifierUse (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Role.code or implied by context
type	Σ	0..1	CodeableConceptBinding	There are no (further) constraints on this element Element id ResearchStudy.identifier.type Short description Description of identifier Definition A coded type for the identifier that can be used to determine which identifier to use for a specific purpose. Requirements Allows users to make use of identifiers when the identifier system is not known. Comments This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type. Data type CodeableConcept Binding A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. Identifier Type Codes (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD v2: CX.5 rim: Role.code or implied by context
system	Σ	0..1	uri	There are no (further) constraints on this element Element id ResearchStudy.identifier.system Short description The namespace for the identifier value Definition Establishes the namespace for the value - that is, a URL that describes a set values that are unique. Requirements There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers. Comments see http://en.wikipedia.org/wiki/Uniform_resource_identifier Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Examples General http://www.acme.com/identifiers/patient Mappings rim: n/a v2: CX.4 / EI-2-4 rim: II.root or Role.id.root servd: ./IdentifierType
value	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.identifier.value Short description The value that is unique Definition The portion of the identifier typically relevant to the user and which is unique within the context of the system. Comments If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Examples General 123456 Mappings rim: n/a v2: CX.1 / EI.1 rim: II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root) servd: ./Value
period	Σ I	0..1	Period	There are no (further) constraints on this element Element id ResearchStudy.identifier.period Short description Time period when id is/was valid for use Definition Time period during which identifier is/was valid for use. Comments This is not a duration - that's a measure of time (a separate type), but a duration that occurs at a fixed value of time. 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"). If duration is required, specify the type as Interval\|Duration. Data type Period Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` per-1: If present, start SHALL have a lower value than end `start.empty() or end.empty() or (start <= end)` Mappings rim: n/a v2: DR rim: IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"] v2: CX.7 + CX.8 rim: Role.effectiveTime or implied by context servd: ./StartDate and ./EndDate
assigner	Σ I	0..1	Reference(CareConnect-Organization-1)	Element id ResearchStudy.identifier.assigner Short description Organization that issued id (may be just text) Definition Organization that issued/manages the identifier. Comments The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization. Data type Reference(CareConnect-Organization-1) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) v2: CX.4 / (CX.4,CX.9,CX.10) rim: II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper servd: ./IdentifierIssuingAuthority
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. Comments Note that FHIR strings may not exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a clinicaltrials-gov: Brief Title
protocol	Σ I	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. Comments 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. Data type Reference(PlanDefinition) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) clinicaltrials-gov: Interventions; Arm/Intervention Cross-Reference rim: .outboundRelationship[typeCode=DEFN].target
partOf	Σ I	0..*	Reference(CareConnect-ResearchStudy-1)	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. Comments 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. Data type Reference(CareConnect-ResearchStudy-1) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) rim: .inboundRelationship[typeCode=COMP].source[moodCode=EVN]
status	Σ ?!	1..1	codeBinding	There are no (further) constraints on this element Element id ResearchStudy.status Short description draft \| in-progress \| suspended \| stopped \| completed \| entered-in-error Definition The current state of the study. Comments This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid. 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() \| (children().count() > id.count())` Mappings rim: n/a rim: .status w5: status
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. Comments 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. 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() \| (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD clinicaltrials-gov: Study Type; Primary Purpose; Study Phase; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention
focus	Σ	0..*	CodeableConcept	There are no (further) constraints on this element Element id ResearchStudy.focus Short description Drugs, devices, conditions, etc. under study Definition The condition(s), medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about. Comments 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. Data type CodeableConcept Binding Codes for medications, devices, conditions and other interventions (unbound) (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD clinicaltrials-gov: Conditions or Focus of Study w5: what
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() \| (children().count() > id.count())` Mappings rim: n/a clinicaltrials-gov: Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators
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. Comments Each related artifact is either an attachment, or a reference to another knowledge resource, but not both. Data type RelatedArtifact Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a clinicaltrials-gov: Citations, Links, Available Study Data/Documents
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. Comments 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. 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() \| (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD clinicaltrials-gov: Keywords
jurisdiction	Σ	0..*	CodeableConceptBinding	There are no (further) constraints on this element Element id ResearchStudy.jurisdiction Short description Geographic region(s) for study Definition Indicates a country, state or other region where the study is taking place. Comments 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. 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() \| (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
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. Comments Systems are not required to have markdown support, and there is considerable variation in markdown syntax, so the text should be readable without markdown processing. The preferred markdown syntax is described here: http://daringfireball.net/projects/markdown/syntax (and tests here: http://daringfireball.net/projects/downloads/MarkdownTest_1.0.zip) Data type markdown Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a clinicaltrials-gov: Detailed Description
enrollment	Σ I	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() \| (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) 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: who.focus
period	Σ I	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. Requirements [The list of types may be constrained as appropriate for the type of event]. Comments This is not a duration - that's a measure of time (a separate type), but a duration that occurs at a fixed value of time. 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"). If duration is required, specify the type as Interval\|Duration. Data type Period Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` per-1: If present, start SHALL have a lower value than end `start.empty() or end.empty() or (start <= end)` Mappings rim: n/a v2: DR rim: IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"] clinicaltrials-gov: Study Start Date (start); Study Completion Date (end) w5: when.done
sponsor	Σ I	0..1	Reference(CareConnect-Organization-1)	Element id ResearchStudy.sponsor Short description Organization responsible for the study Definition The organization responsible for the execution of the study. Comments 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. Data type Reference(CareConnect-Organization-1) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) clinicaltrials-gov: Sponsor w5: who.actor
principalInvestigator	Σ I	0..1	Reference(CareConnect-Practitioner-1)	Element id ResearchStudy.principalInvestigator Short description The individual responsible for the study Definition Indicates the individual who has primary oversite of the execution of the study. Comments 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. Data type Reference(CareConnect-Practitioner-1) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) clinicaltrials-gov: Principal Investigator w5: who.actor
site	Σ I	0..*	Reference(CareConnect-Location-1)	Element id ResearchStudy.site Short description Location involved in study execution Definition Clinic, hospital or other healthcare location that is participating in the study. Comments 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. Data type Reference(CareConnect-Location-1) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) clinicaltrials-gov: Facility w5: where
reasonStopped	Σ	0..1	CodeableConcept	There are no (further) constraints on this element Element id ResearchStudy.reasonStopped Short description Reason for terminating study early Definition A description and/or code explaining the premature termination of the study. Comments 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. Data type CodeableConcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD clinicaltrials-gov: Why Study Stopped w5: why
note		0..*	Annotation	There are no (further) constraints on this element Element id ResearchStudy.note Short description Comments made about the event Definition Comments made about the event by the performer, subject or other participants. Comments 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). Data type Annotation Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.note.id Short description xml:id (or equivalent in JSON) Definition unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Comments Note that FHIR strings may not exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.note.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. In order 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. 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() \| (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
author[x]	Σ	0..1		There are no (further) constraints on this element Element id ResearchStudy.note.author[x] Short description Individual responsible for the annotation Definition The individual responsible for making the annotation. Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act.participant[typeCode=AUT].role
authorString			string	Data type string
authorReference			Reference(CareConnect-Patient-1 \| CareConnect-Practitioner-1 \| CareConnect-RelatedPerson-1)	Data type Reference(CareConnect-Patient-1 \| CareConnect-Practitioner-1 \| CareConnect-RelatedPerson-1)
time	Σ	0..1	dateTime	There are no (further) constraints on this element Element id ResearchStudy.note.time Short description When the annotation was made Definition Indicates when this particular annotation was made. Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act.effectiveTime
text		1..1	string	There are no (further) constraints on this element Element id ResearchStudy.note.text Short description The annotation - text content Definition The text of the annotation. Comments Note that FHIR strings may not exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act.text
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() \| (children().count() > id.count())` Mappings rim: n/a clinicaltrials-gov: Arms
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.arm.id Short description xml:id (or equivalent in JSON) Definition unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Comments Note that FHIR strings may not exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` 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. In order 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. 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() \| (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a 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 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 that contains it. Usually modifier elements provide negation or qualification. In order 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. 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() \| (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a 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. Comments Note that FHIR strings may not exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a clinicaltrials-gov: Arm Label
code		0..1	CodeableConcept	There are no (further) constraints on this element Element id ResearchStudy.arm.code Short description Categorization of study arm Definition Categorization of study arm, e.g. experimental, active comparator, placebo comparater. Comments 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. Data type CodeableConcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD clinicaltrials-gov: Arm Type
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. Comments Note that FHIR strings may not exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a clinicaltrials-gov: Arm Description

Hybrid View

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-1: If the resource is contained in another resource, it SHALL NOT contain any narrative `contained.text.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-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource `contained.where(('#'+id in %resource.descendants().reference).not()).empty()` Mappings rim: Entity. Role, or Act v2: OBX rim: Observation[classCode=CLNTRL, moodCode=EVN] w5: clinical.diagnostics
id	Σ	0..1	id	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 id Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a
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 may 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() \| (children().count() > id.count())` Mappings rim: n/a rim: N/A
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. 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. This element is labelled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a
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. Common Languages (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a
text	I	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 may 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 in formation is added later. Data type Narrative Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a rim: N/A 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. Data type Resource Mappings rim: Entity. Role, or Act 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. In order 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. 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() \| (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a 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. Usually modifier elements provide negation or qualification. In order 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. 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() \| (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a 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() \| (children().count() > id.count())` Mappings rim: n/a v2: CX / EI (occasionally, more often EI maps to a resource id or a URL) rim: II - see see identifier pattern at http://wiki.hl7.org/index.php?title=Common_Design_Patterns#Identifier_Pattern for relevant discussion. 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] servd: Identifier clinicaltrials-gov: Organization's Unique Protocol ID; Secondary IDs rim: .identifier w5: id
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.identifier.id Short description xml:id (or equivalent in JSON) Definition unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Comments Note that FHIR strings may not exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.identifier.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. In order 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. 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() \| (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
use	Σ ?!	0..1	codeBinding	There are no (further) constraints on this element Element id ResearchStudy.identifier.use Short description usual \| official \| temp \| secondary (If known) Definition The purpose of this identifier. Requirements Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. Comments This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. Data type code Binding Identifies the purpose for this identifier, if known . IdentifierUse (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Role.code or implied by context
type	Σ	0..1	CodeableConceptBinding	There are no (further) constraints on this element Element id ResearchStudy.identifier.type Short description Description of identifier Definition A coded type for the identifier that can be used to determine which identifier to use for a specific purpose. Requirements Allows users to make use of identifiers when the identifier system is not known. Comments This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type. Data type CodeableConcept Binding A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. Identifier Type Codes (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD v2: CX.5 rim: Role.code or implied by context
system	Σ	0..1	uri	There are no (further) constraints on this element Element id ResearchStudy.identifier.system Short description The namespace for the identifier value Definition Establishes the namespace for the value - that is, a URL that describes a set values that are unique. Requirements There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers. Comments see http://en.wikipedia.org/wiki/Uniform_resource_identifier Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Examples General http://www.acme.com/identifiers/patient Mappings rim: n/a v2: CX.4 / EI-2-4 rim: II.root or Role.id.root servd: ./IdentifierType
value	Σ	0..1	string	There are no (further) constraints on this element Element id ResearchStudy.identifier.value Short description The value that is unique Definition The portion of the identifier typically relevant to the user and which is unique within the context of the system. Comments If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Examples General 123456 Mappings rim: n/a v2: CX.1 / EI.1 rim: II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root) servd: ./Value
period	Σ I	0..1	Period	There are no (further) constraints on this element Element id ResearchStudy.identifier.period Short description Time period when id is/was valid for use Definition Time period during which identifier is/was valid for use. Comments This is not a duration - that's a measure of time (a separate type), but a duration that occurs at a fixed value of time. 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"). If duration is required, specify the type as Interval\|Duration. Data type Period Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` per-1: If present, start SHALL have a lower value than end `start.empty() or end.empty() or (start <= end)` Mappings rim: n/a v2: DR rim: IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"] v2: CX.7 + CX.8 rim: Role.effectiveTime or implied by context servd: ./StartDate and ./EndDate
assigner	Σ I	0..1	Reference(CareConnect-Organization-1)	Element id ResearchStudy.identifier.assigner Short description Organization that issued id (may be just text) Definition Organization that issued/manages the identifier. Comments The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization. Data type Reference(CareConnect-Organization-1) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) v2: CX.4 / (CX.4,CX.9,CX.10) rim: II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper servd: ./IdentifierIssuingAuthority
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. Comments Note that FHIR strings may not exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a clinicaltrials-gov: Brief Title
protocol	Σ I	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. Comments 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. Data type Reference(PlanDefinition) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) clinicaltrials-gov: Interventions; Arm/Intervention Cross-Reference rim: .outboundRelationship[typeCode=DEFN].target
partOf	Σ I	0..*	Reference(CareConnect-ResearchStudy-1)	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. Comments 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. Data type Reference(CareConnect-ResearchStudy-1) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) rim: .inboundRelationship[typeCode=COMP].source[moodCode=EVN]
status	Σ ?!	1..1	codeBinding	There are no (further) constraints on this element Element id ResearchStudy.status Short description draft \| in-progress \| suspended \| stopped \| completed \| entered-in-error Definition The current state of the study. Comments This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid. 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() \| (children().count() > id.count())` Mappings rim: n/a rim: .status w5: status
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. Comments 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. 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() \| (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD clinicaltrials-gov: Study Type; Primary Purpose; Study Phase; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention
focus	Σ	0..*	CodeableConcept	There are no (further) constraints on this element Element id ResearchStudy.focus Short description Drugs, devices, conditions, etc. under study Definition The condition(s), medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about. Comments 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. Data type CodeableConcept Binding Codes for medications, devices, conditions and other interventions (unbound) (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD clinicaltrials-gov: Conditions or Focus of Study w5: what
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() \| (children().count() > id.count())` Mappings rim: n/a clinicaltrials-gov: Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators
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. Comments Each related artifact is either an attachment, or a reference to another knowledge resource, but not both. Data type RelatedArtifact Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a clinicaltrials-gov: Citations, Links, Available Study Data/Documents
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. Comments 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. 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() \| (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD clinicaltrials-gov: Keywords
jurisdiction	Σ	0..*	CodeableConceptBinding	There are no (further) constraints on this element Element id ResearchStudy.jurisdiction Short description Geographic region(s) for study Definition Indicates a country, state or other region where the study is taking place. Comments 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. 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() \| (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
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. Comments Systems are not required to have markdown support, and there is considerable variation in markdown syntax, so the text should be readable without markdown processing. The preferred markdown syntax is described here: http://daringfireball.net/projects/markdown/syntax (and tests here: http://daringfireball.net/projects/downloads/MarkdownTest_1.0.zip) Data type markdown Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a clinicaltrials-gov: Detailed Description
enrollment	Σ I	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() \| (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) 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: who.focus
period	Σ I	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. Requirements [The list of types may be constrained as appropriate for the type of event]. Comments This is not a duration - that's a measure of time (a separate type), but a duration that occurs at a fixed value of time. 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"). If duration is required, specify the type as Interval\|Duration. Data type Period Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` per-1: If present, start SHALL have a lower value than end `start.empty() or end.empty() or (start <= end)` Mappings rim: n/a v2: DR rim: IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"] clinicaltrials-gov: Study Start Date (start); Study Completion Date (end) w5: when.done
sponsor	Σ I	0..1	Reference(CareConnect-Organization-1)	Element id ResearchStudy.sponsor Short description Organization responsible for the study Definition The organization responsible for the execution of the study. Comments 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. Data type Reference(CareConnect-Organization-1) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) clinicaltrials-gov: Sponsor w5: who.actor
principalInvestigator	Σ I	0..1	Reference(CareConnect-Practitioner-1)	Element id ResearchStudy.principalInvestigator Short description The individual responsible for the study Definition Indicates the individual who has primary oversite of the execution of the study. Comments 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. Data type Reference(CareConnect-Practitioner-1) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) clinicaltrials-gov: Principal Investigator w5: who.actor
site	Σ I	0..*	Reference(CareConnect-Location-1)	Element id ResearchStudy.site Short description Location involved in study execution Definition Clinic, hospital or other healthcare location that is participating in the study. Comments 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. Data type Reference(CareConnect-Location-1) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) clinicaltrials-gov: Facility w5: where
reasonStopped	Σ	0..1	CodeableConcept	There are no (further) constraints on this element Element id ResearchStudy.reasonStopped Short description Reason for terminating study early Definition A description and/or code explaining the premature termination of the study. Comments 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. Data type CodeableConcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD clinicaltrials-gov: Why Study Stopped w5: why
note		0..*	Annotation	There are no (further) constraints on this element Element id ResearchStudy.note Short description Comments made about the event Definition Comments made about the event by the performer, subject or other participants. Comments 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). Data type Annotation Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.note.id Short description xml:id (or equivalent in JSON) Definition unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Comments Note that FHIR strings may not exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id ResearchStudy.note.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. In order 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. 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() \| (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
author[x]	Σ	0..1		There are no (further) constraints on this element Element id ResearchStudy.note.author[x] Short description Individual responsible for the annotation Definition The individual responsible for making the annotation. Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act.participant[typeCode=AUT].role
authorString			string	Data type string
authorReference			Reference(CareConnect-Patient-1 \| CareConnect-Practitioner-1 \| CareConnect-RelatedPerson-1)	Data type Reference(CareConnect-Patient-1 \| CareConnect-Practitioner-1 \| CareConnect-RelatedPerson-1)
time	Σ	0..1	dateTime	There are no (further) constraints on this element Element id ResearchStudy.note.time Short description When the annotation was made Definition Indicates when this particular annotation was made. Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act.effectiveTime
text		1..1	string	There are no (further) constraints on this element Element id ResearchStudy.note.text Short description The annotation - text content Definition The text of the annotation. Comments Note that FHIR strings may not exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act.text
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() \| (children().count() > id.count())` Mappings rim: n/a clinicaltrials-gov: Arms
id		0..1	string	There are no (further) constraints on this element Element id ResearchStudy.arm.id Short description xml:id (or equivalent in JSON) Definition unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Comments Note that FHIR strings may not exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` 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. In order 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. 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() \| (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a 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 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 that contains it. Usually modifier elements provide negation or qualification. In order 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. 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() \| (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a 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. Comments Note that FHIR strings may not exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a clinicaltrials-gov: Arm Label
code		0..1	CodeableConcept	There are no (further) constraints on this element Element id ResearchStudy.arm.code Short description Categorization of study arm Definition Categorization of study arm, e.g. experimental, active comparator, placebo comparater. Comments 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. Data type CodeableConcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD clinicaltrials-gov: Arm Type
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. Comments Note that FHIR strings may not exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a clinicaltrials-gov: Arm Description

Table View

ResearchStudy		..
ResearchStudy.identifier		..
ResearchStudy.identifier.assigner	Reference(CareConnect-Organization-1)	..
ResearchStudy.partOf	Reference(CareConnect-ResearchStudy-1)	..
ResearchStudy.sponsor	Reference(CareConnect-Organization-1)	..
ResearchStudy.principalInvestigator	Reference(CareConnect-Practitioner-1)	..
ResearchStudy.site	Reference(CareConnect-Location-1)	..
ResearchStudy.note		..
ResearchStudy.note.author[x]	Reference(CareConnect-Patient-1 \| CareConnect-Practitioner-1 \| CareConnect-RelatedPerson-1), string	..

Examples

Profile specific implementation guidance:

There is no specific guidance for this profile.