MyResearchStudy (ResearchStudy) | I | | ResearchStudy | There are no (further) constraints on this element Element idShort description Investigation to increase healthcare-related patient-independent knowledge Alternate names Clinical Trial, Study Definition A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques. A ResearchStudy involves the gathering of information about human or animal subjects.
Comments Need to make sure we encompass public health studies.
Data type ResearchStudy Constraints- dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources
contained.contained.empty() - dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() - dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() - dom-5: If a resource is contained in another resource, it SHALL NOT have a security label
contained.meta.security.empty() - dom-6: A resource should have narrative for robust management
text.`div`.exists()
Mappings- rim: Entity. Role, or Act
- BRIDG5.1: ObservationalStudyProtocolVersion; Study;
StudyProtocolVersion
- v2: OBX
- rim: Observation[classCode=CLNTRL, moodCode=EVN]
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id | Σ | 0..1 | string | There are no (further) constraints on this element Element idShort description Logical id of this artifact Definition The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
Comments The only time that a resource does not have an id is when it is being submitted to the server using a create operation.
Data type string |
meta | Σ | 0..1 | Meta | There are no (further) constraints on this element Element idShort description Metadata about the resource Definition The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.
Data type Meta Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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implicitRules | Σ ?! | 0..1 | uri | There are no (further) constraints on this element Element idResearchStudy.implicitRules Short description A set of rules under which this content was created Definition A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.
Comments Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.
Data type uri Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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language | | 0..1 | codeBinding | There are no (further) constraints on this element Element idShort 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 CommonLanguages (preferred)Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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text | | 0..1 | Narrative | There are no (further) constraints on this element Element idShort description Text summary of the resource, for human interpretation Alternate names narrative, html, xhtml, display Definition A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.
Comments Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.
Data type Narrative Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings |
contained | | 0..* | Resource | There are no (further) constraints on this element Element idShort description Contained, inline Resources Alternate names inline resources, anonymous resources, contained resources Definition These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.
Comments This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.
Data type Resource Mappings |
extension | I | 0..* | Extension | There are no (further) constraints on this element Element idShort description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Data type Extension Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()
Mappings |
modifierExtension | ?! I | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.modifierExtension Short description Extensions that cannot be ignored Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Data type Extension Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()
Mappings |
identifier | Σ | 1..1 | Identifier | There are no (further) constraints on this element Element idShort description Business Identifier for study Definition Identifiers assigned to this research study by the sponsor or other systems.
Requirements Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.
Data type Identifier Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Organization's Unique Protocol ID; Secondary IDs
- w5: FiveWs.identifier
- BRIDG5.1: No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)
- rim: .identifier
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title | Σ | 1..1 | string | There are no (further) constraints on this element Element idShort description Name for this study Definition A short, descriptive user-friendly label for the study.
Data type string Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Brief Title
- BRIDG5.1: No BRIDG mapping (although there is StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)
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protocol | Σ | 0..* | Reference(PlanDefinition) | There are no (further) constraints on this element Element idShort description Steps followed in executing study Definition The set of steps expected to be performed as part of the execution of the study.
Data type Reference(PlanDefinition) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Interventions; Arm/Intervention Cross-Reference
- BRIDG5.1: StudyProtocolDocumentVersionPublicTitle.name
- rim: .outboundRelationship[typeCode=DEFN].target
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partOf | Σ | 0..* | Reference(ResearchStudy) | There are no (further) constraints on this element Element idShort description Part of larger study Alternate names container Definition A larger research study of which this particular study is a component or step.
Requirements Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc.
Data type Reference(ResearchStudy) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- BRIDG5.1: CompanionStudyRelationship
- rim: .inboundRelationship[typeCode=COMP].source[moodCode=EVN]
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status | Σ ?! | 1..1 | codeBinding | There are no (further) constraints on this element Element idShort description active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn Definition The current state of the study.
Data type code Binding Codes that convey the current status of the research study.
ResearchStudyStatus (required)Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- w5: FiveWs.status
- BRIDG5.1: StudyOverallStatus.code
- rim: .status
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primaryPurposeType | Σ | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element idResearchStudy.primaryPurposeType Short description treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility Definition The type of study based upon the intent of the study's activities. A classification of the intent of the study.
Data type CodeableConcept Binding Codes for the main intent of the study.
ResearchStudyPrimaryPurposeType (extensible)Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- BRIDG5.1: StudyProtocolVersion.primaryPurposeTypeCode
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phase | Σ | 0..1 | CodeableConcept | There are no (further) constraints on this element Element idShort description n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 Definition The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
Data type CodeableConcept Binding Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
ResearchStudyPhase (example)Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Study Phase
- BRIDG5.1: StudyProtocolVersion.phaseCode
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category | Σ | 0..* | CodeableConcept | There are no (further) constraints on this element Element idShort description Classifications for the study Definition Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.
Data type CodeableConcept Binding Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.
(unbound) (example)Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention
- BRIDG5.1: InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode
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focus | Σ | 0..* | CodeableConcept | There are no (further) constraints on this element Element idShort description Drugs, devices, etc. under study Definition The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about.
Data type CodeableConcept Binding Codes for medications, devices and other interventions.
(unbound) (example)Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Focus of Study
- w5: FiveWs.what[x]
- BRIDG5.1: InterventionalStudyProtocol.interventionTypeCode
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condition | Σ | 0..* | CodeableConcept | There are no (further) constraints on this element Element idShort description Condition being studied Definition The condition that is the focus of the study. For example, In a study to examine risk factors for Lupus, might have as an inclusion criterion "healthy volunteer", but the target condition code would be a Lupus SNOMED code.
Data type CodeableConcept Binding Identification of the condition or diagnosis.
Condition/Problem/DiagnosisCodes (example)Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Conditions
- w5: FiveWs.what[x]
- BRIDG5.1: StudyCondition.code
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contact | Σ | 0..* | ContactDetail | There are no (further) constraints on this element Element idShort description Contact details for the study Definition Contact details to assist a user in learning more about or engaging with the study.
Data type ContactDetail Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators
- BRIDG5.1: PointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVersion
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relatedArtifact | | 0..* | RelatedArtifact | There are no (further) constraints on this element Element idResearchStudy.relatedArtifact Short description References and dependencies Definition Citations, references and other related documents.
Data type RelatedArtifact Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Citations, Links, Available Study Data/Documents
- BRIDG5.1: StudyProtocolDocument, StudyProtocolDocumentVersion
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keyword | Σ | 0..* | CodeableConcept | There are no (further) constraints on this element Element idShort description Used to search for the study Definition Key terms to aid in searching for or filtering the study.
Data type CodeableConcept Binding Words associated with the study that may be useful in discovery.
(unbound) (example)Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Keywords
- BRIDG5.1: DocumentVersion.keywordCode; DocumentVersion.keywordText
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location | Σ | 0..* | CodeableConceptBinding | There are no (further) constraints on this element Element idShort description Geographic region(s) for study Definition Indicates a country, state or other region where the study is taking place.
Data type CodeableConcept Binding Countries and regions within which this artifact is targeted for use.
Jurisdiction ValueSet (extensible)Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- BRIDG5.1: StudyProtocolVersion.participatingLocationCode
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description | | 0..1 | markdown | There are no (further) constraints on this element Element idResearchStudy.description Short description What this is study doing Definition A full description of how the study is being conducted.
Data type markdown Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Detailed Description
- BRIDG5.1: StudyProtocolDocumentVersion.publicDescription
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enrollment | Σ | 0..* | Reference(Group) | There are no (further) constraints on this element Element idShort description Inclusion & exclusion criteria Alternate names patient Definition Reference to a Group that defines the criteria for and quantity of subjects participating in the study. E.g. " 200 female Europeans between the ages of 20 and 45 with early onset diabetes".
Comments The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource.
Data type Reference(Group) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Enrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)
- w5: FiveWs.subject[x]
- BRIDG5.1: InterventionalStudyProtocol.interventionGroupQuantity
- rim: .participation[typeCode=SBJ].role
- w5: FiveWs.subject
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period | Σ | 1..1 | Period | There are no (further) constraints on this element Element idShort description When the study began and ended Alternate names timing Definition Identifies the start date and the expected (or actual, depending on status) end date for the study.
Data type Period Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Study Start Date (start); Study Completion Date (end)
- w5: FiveWs.done[x]
- BRIDG5.1: ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration
- rim: .effectiveTime
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principalInvestigator | Σ | 1..1 | Reference(Practitioner | PractitionerRole) | There are no (further) constraints on this element Element idResearchStudy.principalInvestigator Short description Researcher who oversees multiple aspects of the study Definition A researcher in a study who oversees multiple aspects of the study, such as concept development, protocol writing, protocol submission for IRB approval, participant recruitment, informed consent, data collection, analysis, interpretation and presentation.
Data type Reference(Practitioner | PractitionerRole) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Principal Investigator
- w5: FiveWs.actor
- BRIDG5.1: StudyInvestigator
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site | Σ | 0..* | Reference(Location) | There are no (further) constraints on this element Element idShort description Facility where study activities are conducted Definition A facility in which study activities are conducted.
Data type Reference(Location) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Facility
- w5: FiveWs.where[x]
- BRIDG5.1: PlannedStudySite; StudySite
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reasonStopped | Σ | 0..1 | CodeableConcept | There are no (further) constraints on this element Element idResearchStudy.reasonStopped Short description accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design Definition A description and/or code explaining the premature termination of the study.
Data type CodeableConcept Binding Codes for why the study ended prematurely.
ResearchStudyReasonStopped (example)Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Why Study Stopped
- w5: FiveWs.why[x]
- BRIDG5.1: StudyOverallStatus.studyStoppedReasonCode
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note | | 0..* | Annotation | There are no (further) constraints on this element Element idShort description Comments made about the study Definition Comments made about the study by the performer, subject or other participants.
Data type Annotation Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- BRIDG5.1: No BRIDG mapping
- rim: .inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]
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arm | | 1..1 | BackboneElement | There are no (further) constraints on this element Element idShort description Defined path through the study for a subject Definition Describes an expected sequence of events for one of the participants of a study. E.g. Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up.
Data type BackboneElement Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Arms
- BRIDG5.1: Arm
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id | | 0..1 | string | There are no (further) constraints on this element Element idShort description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Data type string Mappings |
extension | I | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.arm.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Data type Extension Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()
Mappings |
modifierExtension | Σ ?! I | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.arm.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Data type Extension Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()
Mappings |
name | | 1..1 | string | There are no (further) constraints on this element Element idShort description Label for study arm Definition Unique, human-readable label for this arm of the study.
Data type string Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Arm Label
- BRIDG5.1: Arm.name
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type | | 0..1 | CodeableConcept | There are no (further) constraints on this element Element idShort description Categorization of study arm Definition Categorization of study arm, e.g. experimental, active comparator, placebo comparater.
Data type CodeableConcept Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Arm Type
- BRIDG5.1: Arm.typeCode
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description | | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.arm.description Short description Short explanation of study path Definition A succinct description of the path through the study that would be followed by a subject adhering to this arm.
Data type string Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- clinicaltrials-gov: Arm Description
- BRIDG5.1: Arm.description
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objective | | 0..* | BackboneElement | There are no (further) constraints on this element Element idShort description A goal for the study Definition A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study.
Data type BackboneElement Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings |
id | | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.objective.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Data type string Mappings |
extension | I | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.objective.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Data type Extension Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()
Mappings |
modifierExtension | Σ ?! I | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.objective.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Data type Extension Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()
Mappings |
name | | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.objective.name Short description Label for the objective Definition Unique, human-readable label for this objective of the study.
Data type string Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- BRIDG5.1: No BRIDG mapping (BRIDG has a description, but not a name)
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type | | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element idResearchStudy.objective.type Short description primary | secondary | exploratory Definition The kind of study objective.
Data type CodeableConcept Binding Codes for the kind of study objective.
ResearchStudyObjectiveType (preferred)Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Mappings- BRIDG5.1: StudyObjective.typeCode
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