NCPI FHIR Implementation Guide
0.2.0 - ci-build

NCPI FHIR Implementation Guide - Local Development build (v0.2.0). See the Directory of published versions

Resource Profile: NCPI Study Group

Official URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/study-group Version: 0.2.0
Draft as of 2022-10-31 Computable Name: StudyGroup

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.

While there can be more than one StudyGroup per study, there must be one group representing the entire study enrollment. Patients can be members of more than one StudyGroup.

Added Profile Restrictions

In order to ensure consistency across all NCPI research studies represented in FHIR, there are some additional requirements that are to be enforced:

  • The StudyGroup resource must be of type person.
  • The StudyGroup resource must be actual.
  • The StudyGroup resource must have a quantity.
  • The StudyGroup must include SNOMED#44807982 as one of it’s Codings.
  • When enumerating membership, the StudyGroup resource must have only Patients as members.

A StudyGroup should exist alongside any row level data, but these resources can also exist outside a restricted FHIR server to provide access to non-row level information, such as the number of individuals that can be found in a given study.

Usage:

Formal Views of Profile Content

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

This structure is derived from Group

NameFlagsCard.TypeDescription & Constraintsdoco
.. Group 0..*GroupGroup of multiple entities
... type 1..1codeperson | animal | practitioner | device | medication | substance
Required Pattern: person
... actual 1..1booleanDescriptive or actual
Required Pattern: true
... code 0..1CodeableConceptKind of Group members
Required Pattern: At least the following
.... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
..... system1..1uriIdentity of the terminology system
Fixed Value: http://snomed.info/sct
..... code1..1codeSymbol in syntax defined by the system
Fixed Value: 44807982
..... display1..1stringRepresentation defined by the system
Fixed Value: Participant in research study
... member
.... entity 1..1Reference(Patient)Reference to the group member

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Group C0..*GroupGroup of multiple entities
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... type Σ1..1codeperson | animal | practitioner | device | medication | substance
Binding: GroupType (required): Types of resources that are part of group.


Required Pattern: person
... code Σ0..1CodeableConceptKind of Group members
Binding: (unbound) (example): Kind of particular resource; e.g. cow, syringe, lake, etc.


Required Pattern: At least the following
.... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
..... system1..1uriIdentity of the terminology system
Fixed Value: http://snomed.info/sct
..... code1..1codeSymbol in syntax defined by the system
Fixed Value: 44807982
..... display1..1stringRepresentation defined by the system
Fixed Value: Participant in research study
... quantity Σ1..1unsignedIntNumber of members

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
Group.typerequiredPattern: person
Group.codeexamplePattern: SNOMED CT code 44807982("Participant in research study")

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorGroupIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorGroupIf 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-4errorGroupIf 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-5errorGroupIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceGroupA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
grp-1errorGroupCan only have members if group is "actual"
: member.empty() or (actual = true)
NameFlagsCard.TypeDescription & Constraintsdoco
.. Group C0..*GroupGroup of multiple entities
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..*IdentifierUnique id
... active Σ0..1booleanWhether this group's record is in active use
... type Σ1..1codeperson | animal | practitioner | device | medication | substance
Binding: GroupType (required): Types of resources that are part of group.


Required Pattern: person
... actual ΣC1..1booleanDescriptive or actual
Required Pattern: true
... code Σ0..1CodeableConceptKind of Group members
Binding: (unbound) (example): Kind of particular resource; e.g. cow, syringe, lake, etc.


Required Pattern: At least the following
.... id0..1idUnique id for inter-element referencing
.... extension0..*ExtensionAdditional content defined by implementations
.... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
..... id0..1idUnique id for inter-element referencing
..... extension0..*ExtensionAdditional content defined by implementations
..... system1..1uriIdentity of the terminology system
Fixed Value: http://snomed.info/sct
..... version0..1stringVersion of the system - if relevant
..... code1..1codeSymbol in syntax defined by the system
Fixed Value: 44807982
..... display1..1stringRepresentation defined by the system
Fixed Value: Participant in research study
..... userSelected0..1booleanIf this coding was chosen directly by the user
.... text0..1stringPlain text representation of the concept
... name Σ0..1stringLabel for Group
... quantity Σ1..1unsignedIntNumber of members
... managingEntity Σ0..1Reference(Organization | RelatedPerson | Practitioner | PractitionerRole)Entity that is the custodian of the Group's definition
... characteristic 0..*BackboneElementInclude / Exclude group members by Trait
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... code 1..1CodeableConceptKind of characteristic
Binding: (unbound) (example): List of characteristics used to describe group members; e.g. gender, age, owner, location, etc.

.... value[x] 1..1Value held by characteristic
Binding: (unbound) (example): Value of descriptive member characteristic; e.g. red, male, pneumonia, Caucasian, etc.

..... valueCodeableConceptCodeableConcept
..... valueBooleanboolean
..... valueQuantityQuantity
..... valueRangeRange
..... valueReferenceReference(Any)
.... exclude 1..1booleanGroup includes or excludes
.... period 0..1PeriodPeriod over which characteristic is tested
... member C0..*BackboneElementWho or what is in group
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... entity 1..1Reference(Patient)Reference to the group member
.... period 0..1PeriodPeriod member belonged to the group
.... inactive 0..1booleanIf member is no longer in group

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
Group.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
Group.typerequiredPattern: person
Group.codeexamplePattern: SNOMED CT code 44807982("Participant in research study")
Group.characteristic.codeexample
Group.characteristic.value[x]example

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from Group

Summary

Mandatory: 1 element

Differential View

This structure is derived from Group

NameFlagsCard.TypeDescription & Constraintsdoco
.. Group 0..*GroupGroup of multiple entities
... type 1..1codeperson | animal | practitioner | device | medication | substance
Required Pattern: person
... actual 1..1booleanDescriptive or actual
Required Pattern: true
... code 0..1CodeableConceptKind of Group members
Required Pattern: At least the following
.... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
..... system1..1uriIdentity of the terminology system
Fixed Value: http://snomed.info/sct
..... code1..1codeSymbol in syntax defined by the system
Fixed Value: 44807982
..... display1..1stringRepresentation defined by the system
Fixed Value: Participant in research study
... member
.... entity 1..1Reference(Patient)Reference to the group member

doco Documentation for this format

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Group C0..*GroupGroup of multiple entities
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... type Σ1..1codeperson | animal | practitioner | device | medication | substance
Binding: GroupType (required): Types of resources that are part of group.


Required Pattern: person
... code Σ0..1CodeableConceptKind of Group members
Binding: (unbound) (example): Kind of particular resource; e.g. cow, syringe, lake, etc.


Required Pattern: At least the following
.... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
..... system1..1uriIdentity of the terminology system
Fixed Value: http://snomed.info/sct
..... code1..1codeSymbol in syntax defined by the system
Fixed Value: 44807982
..... display1..1stringRepresentation defined by the system
Fixed Value: Participant in research study
... quantity Σ1..1unsignedIntNumber of members

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
Group.typerequiredPattern: person
Group.codeexamplePattern: SNOMED CT code 44807982("Participant in research study")

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorGroupIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorGroupIf 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-4errorGroupIf 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-5errorGroupIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceGroupA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
grp-1errorGroupCan only have members if group is "actual"
: member.empty() or (actual = true)

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Group C0..*GroupGroup of multiple entities
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..*IdentifierUnique id
... active Σ0..1booleanWhether this group's record is in active use
... type Σ1..1codeperson | animal | practitioner | device | medication | substance
Binding: GroupType (required): Types of resources that are part of group.


Required Pattern: person
... actual ΣC1..1booleanDescriptive or actual
Required Pattern: true
... code Σ0..1CodeableConceptKind of Group members
Binding: (unbound) (example): Kind of particular resource; e.g. cow, syringe, lake, etc.


Required Pattern: At least the following
.... id0..1idUnique id for inter-element referencing
.... extension0..*ExtensionAdditional content defined by implementations
.... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
..... id0..1idUnique id for inter-element referencing
..... extension0..*ExtensionAdditional content defined by implementations
..... system1..1uriIdentity of the terminology system
Fixed Value: http://snomed.info/sct
..... version0..1stringVersion of the system - if relevant
..... code1..1codeSymbol in syntax defined by the system
Fixed Value: 44807982
..... display1..1stringRepresentation defined by the system
Fixed Value: Participant in research study
..... userSelected0..1booleanIf this coding was chosen directly by the user
.... text0..1stringPlain text representation of the concept
... name Σ0..1stringLabel for Group
... quantity Σ1..1unsignedIntNumber of members
... managingEntity Σ0..1Reference(Organization | RelatedPerson | Practitioner | PractitionerRole)Entity that is the custodian of the Group's definition
... characteristic 0..*BackboneElementInclude / Exclude group members by Trait
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... code 1..1CodeableConceptKind of characteristic
Binding: (unbound) (example): List of characteristics used to describe group members; e.g. gender, age, owner, location, etc.

.... value[x] 1..1Value held by characteristic
Binding: (unbound) (example): Value of descriptive member characteristic; e.g. red, male, pneumonia, Caucasian, etc.

..... valueCodeableConceptCodeableConcept
..... valueBooleanboolean
..... valueQuantityQuantity
..... valueRangeRange
..... valueReferenceReference(Any)
.... exclude 1..1booleanGroup includes or excludes
.... period 0..1PeriodPeriod over which characteristic is tested
... member C0..*BackboneElementWho or what is in group
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... entity 1..1Reference(Patient)Reference to the group member
.... period 0..1PeriodPeriod member belonged to the group
.... inactive 0..1booleanIf member is no longer in group

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
Group.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
Group.typerequiredPattern: person
Group.codeexamplePattern: SNOMED CT code 44807982("Participant in research study")
Group.characteristic.codeexample
Group.characteristic.value[x]example

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from Group

Summary

Mandatory: 1 element

 

Other representations of profile: CSV, Excel, Schematron

Notes:

At the very least, there should be one StudyGroup that contains all members of the study. For those studies with more than one consent type, additional StudyGroups can be added.