NCPI-FHIR-IMPLEMENTATION-GUIDE\NCPI Study Group

NCPI FHIR Implementation Guide
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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 2023-06-12				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

Name	Card.	Type	Description & Constraints
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
quantity	1..1	unsignedInt	Number of members
member
entity	1..1	Reference(Patient)	Reference to the group member
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
Group	C	0..*	Group	Group of multiple entities
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
actual	ΣC	1..1	boolean	Descriptive or actual Required Pattern: true
code	Σ	0..1	CodeableConcept	Kind of Group members Binding: (unbound) (example): Kind of particular resource; e.g. cow, syringe, lake, etc. 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
quantity	Σ	1..1	unsignedInt	Number of members
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code
Group.type	required	Pattern: person
Group.code	example	Pattern: C142710("Study Participant")

Constraints

Id	Grade	Path(s)	Details	Requirements
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)

Description & Constraints

Group

C

0..*

Group

Group of multiple entities

id

Σ

0..1

id

Logical id of this artifact

Terminology Bindings

Path

Conformance

ValueSet / Code

Group.language

preferred

CommonLanguages

Additional Bindings

Purpose

AllLanguages

Max Binding

Group.type

required

Pattern: person

Group.code

example

Pattern: C142710("Study Participant")

Group.characteristic.code

example

Group.characteristic.value[x]

example

Constraints

Id	Grade	Path(s)	Details	Requirements
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 Group

Name	Card.	Type	Description & Constraints
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
quantity	1..1	unsignedInt	Number of members
member
entity	1..1	Reference(Patient)	Reference to the group member
Documentation for this format

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Group	C	0..*	Group	Group of multiple entities
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
actual	ΣC	1..1	boolean	Descriptive or actual Required Pattern: true
code	Σ	0..1	CodeableConcept	Kind of Group members Binding: (unbound) (example): Kind of particular resource; e.g. cow, syringe, lake, etc. 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
quantity	Σ	1..1	unsignedInt	Number of members
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code
Group.type	required	Pattern: person
Group.code	example	Pattern: C142710("Study Participant")

Constraints

Id	Grade	Path(s)	Details	Requirements
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)

Snapshot View

Description & Constraints

Group

C

0..*

Group

Group of multiple entities

id

Σ

0..1

id

Logical id of this artifact

Terminology Bindings

Path

Conformance

ValueSet / Code

Group.language

preferred

CommonLanguages

Additional Bindings

Purpose

AllLanguages

Max Binding

Group.type

required

Pattern: person

Group.code

example

Pattern: C142710("Study Participant")

Group.characteristic.code

example

Group.characteristic.value[x]

example

Constraints

Id	Grade	Path(s)	Details	Requirements
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 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.

IG © 2021+ NCPI FHIR Working Group. Package NCPI-FHIR-Implementation-Guide#0.2.0 based on FHIR 4.0.1. Generated 2023-06-12
Links: Table of Contents | QA Report