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 Research Study Group

Official URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-group Version: 0.2.0
Draft as of 2025-12-03 Computable Name: ResearchStudyGroup

Grouping subject participation within a research study is helpful to provide definitive lists of participants that fit a specific criteria such as All Participants or Participants From a Particular Consent Group, etc.

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
.. Group C 0..* Group Group of multiple entities
Constraints: grp-1
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... type Σ 1..1 code person | animal | practitioner | device | medication | substance
Binding: GroupType (required): Types of resources that are part of group.
Required Pattern: person
... code Σ 0..1 CodeableConcept Kind of Group members
Binding Description: (example): Kind of particular resource; e.g. cow, syringe, lake, etc.
Required Pattern: At least the following
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://purl.obolibrary.org/obo/ncit.owl
..... version 0..1 string Version of the system - if relevant
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C142710
..... display 1..1 string Representation defined by the system
Fixed Value: Study Participant
..... userSelected 0..1 boolean If this coding was chosen directly by the user
.... text 0..1 string Plain text representation of the concept
... quantity Σ 1..1 unsignedInt Number of members

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Group.type Base required GroupType 📍4.0.1 FHIR Std.
Group.code Base example Not State Unknown

Constraints

Id Grade Path(s) Description Expression
dom-2 error Group If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Group 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 Group 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 Group If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Group 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()
grp-1 error Group Can only have members if group is "actual" member.empty() or (actual = true)

This structure is derived from Group

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Group 0..* Group Group of multiple entities
... type 1..1 code person | animal | practitioner | device | medication | substance
Required Pattern: person
... actual 1..1 boolean Descriptive or actual
Required Pattern: true
... code 0..1 CodeableConcept Kind of Group members
Required Pattern: At least the following
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://purl.obolibrary.org/obo/ncit.owl
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C142710
..... display 1..1 string Representation defined by the system
Fixed Value: Study Participant
... member
.... entity 1..1 Reference(Patient) Reference to the group member

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Group C 0..* Group Group of multiple entities
Constraints: grp-1
... 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
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Unique id
... active Σ 0..1 boolean Whether this group's record is in active use
... type Σ 1..1 code person | animal | practitioner | device | medication | substance
Binding: GroupType (required): Types of resources that are part of group.
Required Pattern: person
... actual ΣC 1..1 boolean Descriptive or actual
Required Pattern: true
... code Σ 0..1 CodeableConcept Kind of Group members
Binding Description: (example): Kind of particular resource; e.g. cow, syringe, lake, etc.
Required Pattern: At least the following
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://purl.obolibrary.org/obo/ncit.owl
..... version 0..1 string Version of the system - if relevant
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C142710
..... display 1..1 string Representation defined by the system
Fixed Value: Study Participant
..... userSelected 0..1 boolean If this coding was chosen directly by the user
.... text 0..1 string Plain text representation of the concept
... name Σ 0..1 string Label for Group
... quantity Σ 1..1 unsignedInt Number of members
... managingEntity Σ 0..1 Reference(Organization | RelatedPerson | Practitioner | PractitionerRole) Entity that is the custodian of the Group's definition
... characteristic 0..* BackboneElement Include / Exclude group members by Trait
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code 1..1 CodeableConcept Kind of characteristic
Binding Description: (example): List of characteristics used to describe group members; e.g. gender, age, owner, location, etc.
.... value[x] 1..1 Value held by characteristic
Binding Description: (example): Value of descriptive member characteristic; e.g. red, male, pneumonia, Caucasian, etc.
..... valueCodeableConcept CodeableConcept
..... valueBoolean boolean
..... valueQuantity Quantity
..... valueRange Range
..... valueReference Reference(Any)
.... exclude 1..1 boolean Group includes or excludes
.... period 0..1 Period Period over which characteristic is tested
... member C 0..* BackboneElement Who or what is in group
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... entity 1..1 Reference(Patient) Reference to the group member
.... period 0..1 Period Period member belonged to the group
.... inactive 0..1 boolean If member is no longer in group

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Group.language Base preferred Common Languages 📍4.0.1 FHIR Std.
Group.type Base required GroupType 📍4.0.1 FHIR Std.
Group.code Base example Not State Unknown
Group.characteristic.​code Base example Not State Unknown
Group.characteristic.​value[x] Base example Not State Unknown

Constraints

Id Grade Path(s) Description Expression
dom-2 error Group If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Group 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 Group 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 Group If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Group 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()
grp-1 error Group Can only have members if group is "actual" member.empty() or (actual = true)

This structure is derived from Group

Summary

Mandatory: 1 element

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Group C 0..* Group Group of multiple entities
Constraints: grp-1
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... type Σ 1..1 code person | animal | practitioner | device | medication | substance
Binding: GroupType (required): Types of resources that are part of group.
Required Pattern: person
... code Σ 0..1 CodeableConcept Kind of Group members
Binding Description: (example): Kind of particular resource; e.g. cow, syringe, lake, etc.
Required Pattern: At least the following
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://purl.obolibrary.org/obo/ncit.owl
..... version 0..1 string Version of the system - if relevant
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C142710
..... display 1..1 string Representation defined by the system
Fixed Value: Study Participant
..... userSelected 0..1 boolean If this coding was chosen directly by the user
.... text 0..1 string Plain text representation of the concept
... quantity Σ 1..1 unsignedInt Number of members

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Group.type Base required GroupType 📍4.0.1 FHIR Std.
Group.code Base example Not State Unknown

Constraints

Id Grade Path(s) Description Expression
dom-2 error Group If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Group 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 Group 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 Group If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Group 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()
grp-1 error Group Can only have members if group is "actual" member.empty() or (actual = true)

Differential View

This structure is derived from Group

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Group 0..* Group Group of multiple entities
... type 1..1 code person | animal | practitioner | device | medication | substance
Required Pattern: person
... actual 1..1 boolean Descriptive or actual
Required Pattern: true
... code 0..1 CodeableConcept Kind of Group members
Required Pattern: At least the following
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://purl.obolibrary.org/obo/ncit.owl
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C142710
..... display 1..1 string Representation defined by the system
Fixed Value: Study Participant
... member
.... entity 1..1 Reference(Patient) Reference to the group member

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Group C 0..* Group Group of multiple entities
Constraints: grp-1
... 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
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Unique id
... active Σ 0..1 boolean Whether this group's record is in active use
... type Σ 1..1 code person | animal | practitioner | device | medication | substance
Binding: GroupType (required): Types of resources that are part of group.
Required Pattern: person
... actual ΣC 1..1 boolean Descriptive or actual
Required Pattern: true
... code Σ 0..1 CodeableConcept Kind of Group members
Binding Description: (example): Kind of particular resource; e.g. cow, syringe, lake, etc.
Required Pattern: At least the following
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://purl.obolibrary.org/obo/ncit.owl
..... version 0..1 string Version of the system - if relevant
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C142710
..... display 1..1 string Representation defined by the system
Fixed Value: Study Participant
..... userSelected 0..1 boolean If this coding was chosen directly by the user
.... text 0..1 string Plain text representation of the concept
... name Σ 0..1 string Label for Group
... quantity Σ 1..1 unsignedInt Number of members
... managingEntity Σ 0..1 Reference(Organization | RelatedPerson | Practitioner | PractitionerRole) Entity that is the custodian of the Group's definition
... characteristic 0..* BackboneElement Include / Exclude group members by Trait
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code 1..1 CodeableConcept Kind of characteristic
Binding Description: (example): List of characteristics used to describe group members; e.g. gender, age, owner, location, etc.
.... value[x] 1..1 Value held by characteristic
Binding Description: (example): Value of descriptive member characteristic; e.g. red, male, pneumonia, Caucasian, etc.
..... valueCodeableConcept CodeableConcept
..... valueBoolean boolean
..... valueQuantity Quantity
..... valueRange Range
..... valueReference Reference(Any)
.... exclude 1..1 boolean Group includes or excludes
.... period 0..1 Period Period over which characteristic is tested
... member C 0..* BackboneElement Who or what is in group
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... entity 1..1 Reference(Patient) Reference to the group member
.... period 0..1 Period Period member belonged to the group
.... inactive 0..1 boolean If member is no longer in group

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Group.language Base preferred Common Languages 📍4.0.1 FHIR Std.
Group.type Base required GroupType 📍4.0.1 FHIR Std.
Group.code Base example Not State Unknown
Group.characteristic.​code Base example Not State Unknown
Group.characteristic.​value[x] Base example Not State Unknown

Constraints

Id Grade Path(s) Description Expression
dom-2 error Group If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Group 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 Group 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 Group If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Group 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()
grp-1 error Group Can only have members if group is "actual" member.empty() or (actual = true)

This structure is derived from Group

Summary

Mandatory: 1 element

 

Other representations of profile: CSV, Excel, Schematron