For the purposes of interoperability, some restrictions have been made to enforce a common mechanism for describing enrollment and provide a simple means for summarizing subject count as well as access control through the main (parent) consent groups. In addition, we are providing some recommended practices for the common data elements required for submission.

Please see the research study documentation for in-depth mappings on the R4 version and the necessary extensions needed to ensure interoperability.

Added Profile Restrictions

To ensure consistency across all NCPI research studies represented in FHIR, there are some additional requirements which must be enforced. These requirements are derived from the Differential Table section of this document.

The following requirements are true for all NCPI Research Studies:

• enrollment must contain 1 reference of type, Study Group.
• category must contain the Coding from NCPI StudyCohort.
• each study should have its accession ID added as an identifier. This is an identifier provided by DbGAP or other organization which represents a common identifier recognized by similar research groups.
• each study should have its study name as the title.
• for those studies which exist as part of a larger study, the parent study should be referenced in the study’s partOf property.
• principalInvestigator must be of type Practitioner if present.

Recommended Practices

To ensure consistency across all NCPI research studies represented in FHIR, there are some additional elements which should be included if applicable to your study. A recommended element is one that is important and will likely have value for those trying to understand the study’s purpose and usefulness but not essential for validation against the profile. Those elements labeled as optional are not central to the fundamental understanding of the study’s content but may play a key role in a study being findable.

Common Data Elements

For a more detailed view of these elements as well as the recommended FHIR mappings please see the research study documentation.

Population Details

Each NCPI Research must have one Study Group which must, at the very least, indicate the total number of patients enrolled at the time the data was loaded into FHIR.

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

This structure is derived from ResearchStudy

Name	Flags	Card.	Type	Description & Constraints
ResearchStudy		0..*	ResearchStudy	Investigation to increase healthcare-related patient-independent knowledge
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
studyDesign		0..*	CodeableConcept	Research Study Design URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-study-design Binding: Study Design (example)
category
coding		0..*	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: https://nih-ncpi.github.io/ncpi-fhir-ig/CodeSystem/ncpi
code		1..1	code	Symbol in syntax defined by the system Fixed Value: StudyCohort
display		1..1	string	Representation defined by the system Fixed Value: Study Cohort
enrollment		1..1	Reference(NCPI Study Group)	Inclusion & exclusion criteria
sponsor		0..1	Reference(Research Consortium)	Organization that initiates and is legally responsible for the study
principalInvestigator		0..1	Reference(Practitioner)	Researcher who oversees multiple aspects of the study
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
ResearchStudy		0..*	ResearchStudy	Investigation to increase healthcare-related patient-independent knowledge
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
studyDesign		0..*	CodeableConcept	Research Study Design URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-study-design Binding: Study Design (example)
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
status	?!Σ	1..1	code	active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study.
enrollment	Σ	1..1	Reference(NCPI Study Group)	Inclusion & exclusion criteria
sponsor	Σ	0..1	Reference(Research Consortium)	Organization that initiates and is legally responsible for the study
principalInvestigator	Σ	0..1	Reference(Practitioner)	Researcher who oversees multiple aspects of the study
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
ResearchStudy.status	required	ResearchStudyStatus

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	ResearchStudy	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	ResearchStudy	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	ResearchStudy	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	ResearchStudy	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	ResearchStudy	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()

Name	Flags	Card.	Type	Description & Constraints
ResearchStudy		0..*	ResearchStudy	Investigation to increase healthcare-related patient-independent knowledge
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): A human language. Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
studyDesign		0..*	CodeableConcept	Research Study Design URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-study-design Binding: Study Design (example)
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Business Identifier for study
title	Σ	0..1	string	Name for this study
protocol	Σ	0..*	Reference(PlanDefinition)	Steps followed in executing study
partOf	Σ	0..*	Reference(ResearchStudy)	Part of larger study
status	?!Σ	1..1	code	active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study.
primaryPurposeType	Σ	0..1	CodeableConcept	treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility Binding: ResearchStudyPrimaryPurposeType (extensible): Codes for the main intent of the study.
phase	Σ	0..1	CodeableConcept	n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 Binding: ResearchStudyPhase (example): Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
category	Σ	0..*	CodeableConcept	Classifications for the study Binding: (unbound) (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system Required Pattern: At least the following
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: https://nih-ncpi.github.io/ncpi-fhir-ig/CodeSystem/ncpi
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: StudyCohort
display		1..1	string	Representation defined by the system Fixed Value: Study Cohort
userSelected		0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
focus	Σ	0..*	CodeableConcept	Drugs, devices, etc. under study Binding: (unbound) (example): Codes for medications, devices and other interventions.
condition	Σ	0..*	CodeableConcept	Condition being studied Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis.
contact	Σ	0..*	ContactDetail	Contact details for the study
relatedArtifact		0..*	RelatedArtifact	References and dependencies
keyword	Σ	0..*	CodeableConcept	Used to search for the study Binding: (unbound) (example): Words associated with the study that may be useful in discovery.
location	Σ	0..*	CodeableConcept	Geographic region(s) for study Binding: Jurisdiction ValueSet (extensible): Countries and regions within which this artifact is targeted for use.
description		0..1	markdown	What this is study doing
enrollment	Σ	1..1	Reference(NCPI Study Group)	Inclusion & exclusion criteria
period	Σ	0..1	Period	When the study began and ended
sponsor	Σ	0..1	Reference(Research Consortium)	Organization that initiates and is legally responsible for the study
principalInvestigator	Σ	0..1	Reference(Practitioner)	Researcher who oversees multiple aspects of the study
site	Σ	0..*	Reference(Location)	Facility where study activities are conducted
reasonStopped	Σ	0..1	CodeableConcept	accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design Binding: ResearchStudyReasonStopped (example): Codes for why the study ended prematurely.
note		0..*	Annotation	Comments made about the study
arm		0..*	BackboneElement	Defined path through the study for a subject
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
name		1..1	string	Label for study arm
type		0..1	CodeableConcept	Categorization of study arm
description		0..1	string	Short explanation of study path
objective		0..*	BackboneElement	A goal for the study
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
name		0..1	string	Label for the objective
type		0..1	CodeableConcept	primary | secondary | exploratory Binding: ResearchStudyObjectiveType (preferred): Codes for the kind of study objective.
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
ResearchStudy.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding
ResearchStudy.status	required	ResearchStudyStatus
ResearchStudy.primaryPurposeType	extensible	ResearchStudyPrimaryPurposeType
ResearchStudy.phase	example	ResearchStudyPhase
ResearchStudy.category	example
ResearchStudy.focus	example
ResearchStudy.condition	example	Condition/Problem/DiagnosisCodes
ResearchStudy.keyword	example
ResearchStudy.location	extensible	Jurisdiction ValueSet
ResearchStudy.reasonStopped	example	ResearchStudyReasonStopped
ResearchStudy.objective.type	preferred	ResearchStudyObjectiveType

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 ResearchStudy

Name	Flags	Card.	Type	Description & Constraints
ResearchStudy		0..*	ResearchStudy	Investigation to increase healthcare-related patient-independent knowledge
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
studyDesign		0..*	CodeableConcept	Research Study Design URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-study-design Binding: Study Design (example)
category
coding		0..*	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: https://nih-ncpi.github.io/ncpi-fhir-ig/CodeSystem/ncpi
code		1..1	code	Symbol in syntax defined by the system Fixed Value: StudyCohort
display		1..1	string	Representation defined by the system Fixed Value: Study Cohort
enrollment		1..1	Reference(NCPI Study Group)	Inclusion & exclusion criteria
sponsor		0..1	Reference(Research Consortium)	Organization that initiates and is legally responsible for the study
principalInvestigator		0..1	Reference(Practitioner)	Researcher who oversees multiple aspects of the study
Documentation for this format

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
ResearchStudy		0..*	ResearchStudy	Investigation to increase healthcare-related patient-independent knowledge
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
studyDesign		0..*	CodeableConcept	Research Study Design URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-study-design Binding: Study Design (example)
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
status	?!Σ	1..1	code	active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study.
enrollment	Σ	1..1	Reference(NCPI Study Group)	Inclusion & exclusion criteria
sponsor	Σ	0..1	Reference(Research Consortium)	Organization that initiates and is legally responsible for the study
principalInvestigator	Σ	0..1	Reference(Practitioner)	Researcher who oversees multiple aspects of the study
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
ResearchStudy.status	required	ResearchStudyStatus

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	ResearchStudy	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	ResearchStudy	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	ResearchStudy	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	ResearchStudy	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	ResearchStudy	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()

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
ResearchStudy		0..*	ResearchStudy	Investigation to increase healthcare-related patient-independent knowledge
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): A human language. Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
studyDesign		0..*	CodeableConcept	Research Study Design URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-study-design Binding: Study Design (example)
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Business Identifier for study
title	Σ	0..1	string	Name for this study
protocol	Σ	0..*	Reference(PlanDefinition)	Steps followed in executing study
partOf	Σ	0..*	Reference(ResearchStudy)	Part of larger study
status	?!Σ	1..1	code	active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study.
primaryPurposeType	Σ	0..1	CodeableConcept	treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility Binding: ResearchStudyPrimaryPurposeType (extensible): Codes for the main intent of the study.
phase	Σ	0..1	CodeableConcept	n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 Binding: ResearchStudyPhase (example): Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
category	Σ	0..*	CodeableConcept	Classifications for the study Binding: (unbound) (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system Required Pattern: At least the following
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: https://nih-ncpi.github.io/ncpi-fhir-ig/CodeSystem/ncpi
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: StudyCohort
display		1..1	string	Representation defined by the system Fixed Value: Study Cohort
userSelected		0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
focus	Σ	0..*	CodeableConcept	Drugs, devices, etc. under study Binding: (unbound) (example): Codes for medications, devices and other interventions.
condition	Σ	0..*	CodeableConcept	Condition being studied Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis.
contact	Σ	0..*	ContactDetail	Contact details for the study
relatedArtifact		0..*	RelatedArtifact	References and dependencies
keyword	Σ	0..*	CodeableConcept	Used to search for the study Binding: (unbound) (example): Words associated with the study that may be useful in discovery.
location	Σ	0..*	CodeableConcept	Geographic region(s) for study Binding: Jurisdiction ValueSet (extensible): Countries and regions within which this artifact is targeted for use.
description		0..1	markdown	What this is study doing
enrollment	Σ	1..1	Reference(NCPI Study Group)	Inclusion & exclusion criteria
period	Σ	0..1	Period	When the study began and ended
sponsor	Σ	0..1	Reference(Research Consortium)	Organization that initiates and is legally responsible for the study
principalInvestigator	Σ	0..1	Reference(Practitioner)	Researcher who oversees multiple aspects of the study
site	Σ	0..*	Reference(Location)	Facility where study activities are conducted
reasonStopped	Σ	0..1	CodeableConcept	accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design Binding: ResearchStudyReasonStopped (example): Codes for why the study ended prematurely.
note		0..*	Annotation	Comments made about the study
arm		0..*	BackboneElement	Defined path through the study for a subject
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
name		1..1	string	Label for study arm
type		0..1	CodeableConcept	Categorization of study arm
description		0..1	string	Short explanation of study path
objective		0..*	BackboneElement	A goal for the study
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
name		0..1	string	Label for the objective
type		0..1	CodeableConcept	primary | secondary | exploratory Binding: ResearchStudyObjectiveType (preferred): Codes for the kind of study objective.
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
ResearchStudy.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding
ResearchStudy.status	required	ResearchStudyStatus
ResearchStudy.primaryPurposeType	extensible	ResearchStudyPrimaryPurposeType
ResearchStudy.phase	example	ResearchStudyPhase
ResearchStudy.category	example
ResearchStudy.focus	example
ResearchStudy.condition	example	Condition/Problem/DiagnosisCodes
ResearchStudy.keyword	example
ResearchStudy.location	extensible	Jurisdiction ValueSet
ResearchStudy.reasonStopped	example	ResearchStudyReasonStopped
ResearchStudy.objective.type	preferred	ResearchStudyObjectiveType

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 ResearchStudy

Summary

Mandatory: 1 element

Structures

This structure refers to these other structures:

• NCPI Study Group (https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/study-group)
• Research Consortium (https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/ncpi-research-consortium)

Extensions

This structure refers to these extensions:

• https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-study-design

As mentioned in the section, “Added Profile Restrictions” above, each NCPI Research must have one NCPI Study Group which must, at the very least, indicate the total number of patients enrolled at the time the data was loaded into FHIR.

Practices for Summary Only Resources

For Studies loaded into Summary Only FHIR servers, the Study’s Study Group resources must have the quantity. This promotes findability by enabling researches without current access to the study’s row-level data to get basic study details including the different subject counts.

For studies that exist alongside row-level data, the Study’s Study Group resources should have each corresponding Patient referenced in the Group’s members array.