NCPI FHIR Implementation Guide v2
0.2.0 - ci-build

NCPI FHIR Implementation Guide v2 - Local Development build (v0.2.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: NCPI Study Participant

Official URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/ncpi-Study-Participant Version: 0.2.0
Draft as of 2025-12-03 Computable Name: NcpiStudyParticipant

Research Study

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchSubject 0..* ResearchSubject Physical entity which is the primary unit of interest in the study
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:accessPolicy 0..* Reference(NCPI Research Access Policy) The Access Policy that may apply to this participant's data from this study. Not canonical, ie, one must rely on the row level AP.
URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/access-policy
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... study Σ 1..1 Reference(ResearchStudy) The Research Study this participant has a relationship with
... individual Σ 1..1 Reference(NCPI Participant) The participant we are describing

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ResearchSubject.status Base required ResearchSubjectStatus 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error ResearchSubject If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error ResearchSubject 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 error ResearchSubject 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 error ResearchSubject If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice ResearchSubject A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

This structure is derived from ResearchSubject

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchSubject 0..* ResearchSubject Physical entity which is the primary unit of interest in the study
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:accessPolicy 0..* Reference(NCPI Research Access Policy) The Access Policy that may apply to this participant's data from this study. Not canonical, ie, one must rely on the row level AP.
URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/access-policy
... study 1..1 Reference(ResearchStudy) The Research Study this participant has a relationship with
... individual 1..1 Reference(NCPI Participant) The participant we are describing

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchSubject 0..* ResearchSubject Physical entity which is the primary unit of interest in the study
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:accessPolicy 0..* Reference(NCPI Research Access Policy) The Access Policy that may apply to this participant's data from this study. Not canonical, ie, one must rely on the row level AP.
URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/access-policy
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Business Identifier for research subject in a study
... status ?!Σ 1..1 code candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn
Binding: ResearchSubjectStatus (required): Indicates the progression of a study subject through a study.
... period Σ 0..1 Period Start and end of participation
... study Σ 1..1 Reference(ResearchStudy) The Research Study this participant has a relationship with
... individual Σ 1..1 Reference(NCPI Participant) The participant we are describing
... assignedArm 0..1 string What path should be followed
... actualArm 0..1 string What path was followed
... consent 0..1 Reference(Consent) Agreement to participate in study

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ResearchSubject.language Base preferred Common Languages 📍4.0.1 FHIR Std.
ResearchSubject.status Base required ResearchSubjectStatus 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error ResearchSubject If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error ResearchSubject 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 error ResearchSubject 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 error ResearchSubject If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice ResearchSubject A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

This structure is derived from ResearchSubject

Summary

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchSubject 0..* ResearchSubject Physical entity which is the primary unit of interest in the study
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:accessPolicy 0..* Reference(NCPI Research Access Policy) The Access Policy that may apply to this participant's data from this study. Not canonical, ie, one must rely on the row level AP.
URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/access-policy
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... study Σ 1..1 Reference(ResearchStudy) The Research Study this participant has a relationship with
... individual Σ 1..1 Reference(NCPI Participant) The participant we are describing

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ResearchSubject.status Base required ResearchSubjectStatus 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error ResearchSubject If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error ResearchSubject 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 error ResearchSubject 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 error ResearchSubject If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice ResearchSubject A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

Differential View

This structure is derived from ResearchSubject

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchSubject 0..* ResearchSubject Physical entity which is the primary unit of interest in the study
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:accessPolicy 0..* Reference(NCPI Research Access Policy) The Access Policy that may apply to this participant's data from this study. Not canonical, ie, one must rely on the row level AP.
URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/access-policy
... study 1..1 Reference(ResearchStudy) The Research Study this participant has a relationship with
... individual 1..1 Reference(NCPI Participant) The participant we are describing

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchSubject 0..* ResearchSubject Physical entity which is the primary unit of interest in the study
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:accessPolicy 0..* Reference(NCPI Research Access Policy) The Access Policy that may apply to this participant's data from this study. Not canonical, ie, one must rely on the row level AP.
URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/access-policy
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Business Identifier for research subject in a study
... status ?!Σ 1..1 code candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn
Binding: ResearchSubjectStatus (required): Indicates the progression of a study subject through a study.
... period Σ 0..1 Period Start and end of participation
... study Σ 1..1 Reference(ResearchStudy) The Research Study this participant has a relationship with
... individual Σ 1..1 Reference(NCPI Participant) The participant we are describing
... assignedArm 0..1 string What path should be followed
... actualArm 0..1 string What path was followed
... consent 0..1 Reference(Consent) Agreement to participate in study

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ResearchSubject.language Base preferred Common Languages 📍4.0.1 FHIR Std.
ResearchSubject.status Base required ResearchSubjectStatus 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error ResearchSubject If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error ResearchSubject 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 error ResearchSubject 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 error ResearchSubject If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice ResearchSubject A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

This structure is derived from ResearchSubject

Summary

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

 

Other representations of profile: CSV, Excel, Schematron