Key Guidelines

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 the NCIT Code, C142710 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.

At the very least, the Study Group should provide the count of subjects it represents.

• Differential Table
• Key Elements Table
• Snapshot Table
• Statistics/References
• All

This structure is derived from Group

Name	Flags	Card.	Type	Description & Constraints
Group			Group
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 grp-1: Can only have members if group is "actual"
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	URI
Group.type	required	Pattern: person http://hl7.org/fhir/ValueSet/group-type|4.3.0 from the FHIR Standard
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.exists() and ('#'+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(uri) = '#').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)

Name	Flags	Card.	Type	Description & Constraints
Group	C	0..*	Group	Group of multiple entities grp-1: Can only have members if group is "actual"
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
language		0..1	code	Language of the resource content Binding: CommonLanguages (preferred): IETF language tag Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources dom-r4b: Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems
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: (unbound) (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: (unbound) (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: (unbound) (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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Group.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
Group.type	required	Pattern: person http://hl7.org/fhir/ValueSet/group-type|4.3.0 from the FHIR Standard
Group.code	example	Pattern: C142710("Study Participant")
Group.characteristic.code	example
Group.characteristic.value[x]	example

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.exists() and ('#'+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(uri) = '#').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()
dom-r4b	warning	Group.contained	Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems : ($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic)
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

Name	Flags	Card.	Type	Description & Constraints
Group			Group
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 grp-1: Can only have members if group is "actual"
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	URI
Group.type	required	Pattern: person http://hl7.org/fhir/ValueSet/group-type|4.3.0 from the FHIR Standard
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.exists() and ('#'+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(uri) = '#').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

Name	Flags	Card.	Type	Description & Constraints
Group	C	0..*	Group	Group of multiple entities grp-1: Can only have members if group is "actual"
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
language		0..1	code	Language of the resource content Binding: CommonLanguages (preferred): IETF language tag Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources dom-r4b: Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems
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: (unbound) (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: (unbound) (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: (unbound) (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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Group.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
Group.type	required	Pattern: person http://hl7.org/fhir/ValueSet/group-type|4.3.0 from the FHIR Standard
Group.code	example	Pattern: C142710("Study Participant")
Group.characteristic.code	example
Group.characteristic.value[x]	example

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.exists() and ('#'+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(uri) = '#').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()
dom-r4b	warning	Group.contained	Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems : ($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic)
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

For top level studies, the group should represent the entirety of the study. For sub-studies and consent groups, the Study Group should contain all members of that study or consent grouping.