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 Research Study

Official URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/ncpi-research-study Version: 0.2.0
Draft as of 2022-10-07 Computable Name: NcpiResearchStudy

The NCPI Research Study is based upon the core FHIR ResearchStudy resource and shall act as the umbrella under which all study resources can ultimately be found. 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 and consent group membership.

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 following requirements are true for all NCPI Research Studies:

  • enrollment must contain 1 or more reference
  • enrollment must only reference NCPI StudyGroup resources
  • category must contain the Coding from NCPI StudyCohort

In order to support interoperability, whenever possible, the NCPI Research Study resource should have one or more Codings provided for the Study’s condition property indicating the disease or phenotype’s that were interrogated during the study’s execution.

Usage:

Formal Views of Profile Content

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

This structure is derived from ResearchStudy

Summary

Mandatory: 1 element

Structures

This structure refers to these other structures:

This structure is derived from ResearchStudy

NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy 0..*ResearchStudyInvestigation to increase healthcare-related patient-independent knowledge
... category
.... coding 0..*CodingCode defined by a terminology system
Required Pattern: At least the following
..... system1..1uriIdentity of the terminology system
Fixed Value: https://nih-ncpi.github.io/ncpi-fhir-ig
..... code1..1codeSymbol in syntax defined by the system
Fixed Value: StudyCohort
..... display1..1stringRepresentation defined by the system
Fixed Value: Study Cohort
... enrollment 1..*Reference(NCPI Study Group)Inclusion & exclusion criteria

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy 0..*ResearchStudyInvestigation to increase healthcare-related patient-independent knowledge
... 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
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred): A human language.

Additional BindingsPurpose
AllLanguagesMax Binding
... 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..*IdentifierBusiness Identifier for study
... title Σ0..1stringName for this study
... protocol Σ0..*Reference(PlanDefinition)Steps followed in executing study
... partOf Σ0..*Reference(ResearchStudy)Part of larger study
... status ?!Σ1..1codeactive | 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 Σ0..1CodeableConcepttreatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
Binding: ResearchStudyPrimaryPurposeType (extensible): Codes for the main intent of the study.

... phase Σ0..1CodeableConceptn-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 Σ0..*CodeableConceptClassifications 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..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ0..*CodingCode defined by a terminology system

Required Pattern: At least the following
..... id0..1idUnique id for inter-element referencing
..... extension0..*ExtensionAdditional content defined by implementations
..... system1..1uriIdentity of the terminology system
Fixed Value: https://nih-ncpi.github.io/ncpi-fhir-ig
..... version0..1stringVersion of the system - if relevant
..... code1..1codeSymbol in syntax defined by the system
Fixed Value: StudyCohort
..... display1..1stringRepresentation defined by the system
Fixed Value: Study Cohort
..... userSelected0..1booleanIf this coding was chosen directly by the user
.... text Σ0..1stringPlain text representation of the concept
... focus Σ0..*CodeableConceptDrugs, devices, etc. under study
Binding: (unbound) (example): Codes for medications, devices and other interventions.


... condition Σ0..*CodeableConceptCondition being studied
Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis.


... contact Σ0..*ContactDetailContact details for the study
... relatedArtifact 0..*RelatedArtifactReferences and dependencies
... keyword Σ0..*CodeableConceptUsed to search for the study
Binding: (unbound) (example): Words associated with the study that may be useful in discovery.


... location Σ0..*CodeableConceptGeographic region(s) for study
Binding: Jurisdiction ValueSet (extensible): Countries and regions within which this artifact is targeted for use.


... description 0..1markdownWhat this is study doing
... enrollment Σ1..*Reference(NCPI Study Group)Inclusion & exclusion criteria
... period Σ0..1PeriodWhen the study began and ended
... sponsor Σ0..1Reference(Organization)Organization that initiates and is legally responsible for the study
... principalInvestigator Σ0..1Reference(Practitioner | PractitionerRole)Researcher who oversees multiple aspects of the study
... site Σ0..*Reference(Location)Facility where study activities are conducted
... reasonStopped Σ0..1CodeableConceptaccrual-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..*AnnotationComments made about the study
... arm 0..*BackboneElementDefined path through the study for a subject
.... 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
.... name 1..1stringLabel for study arm
.... type 0..1CodeableConceptCategorization of study arm
.... description 0..1stringShort explanation of study path
... objective 0..*BackboneElementA goal for the study
.... 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
.... name 0..1stringLabel for the objective
.... type 0..1CodeableConceptprimary | secondary | exploratory
Binding: ResearchStudyObjectiveType (preferred): Codes for the kind of study objective.


doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy 0..*ResearchStudyInvestigation to increase healthcare-related patient-independent knowledge

doco Documentation for this format

This structure is derived from ResearchStudy

Summary

Mandatory: 1 element

Structures

This structure refers to these other structures:

Differential View

This structure is derived from ResearchStudy

NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy 0..*ResearchStudyInvestigation to increase healthcare-related patient-independent knowledge
... category
.... coding 0..*CodingCode defined by a terminology system
Required Pattern: At least the following
..... system1..1uriIdentity of the terminology system
Fixed Value: https://nih-ncpi.github.io/ncpi-fhir-ig
..... code1..1codeSymbol in syntax defined by the system
Fixed Value: StudyCohort
..... display1..1stringRepresentation defined by the system
Fixed Value: Study Cohort
... enrollment 1..*Reference(NCPI Study Group)Inclusion & exclusion criteria

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy 0..*ResearchStudyInvestigation to increase healthcare-related patient-independent knowledge
... 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
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred): A human language.

Additional BindingsPurpose
AllLanguagesMax Binding
... 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..*IdentifierBusiness Identifier for study
... title Σ0..1stringName for this study
... protocol Σ0..*Reference(PlanDefinition)Steps followed in executing study
... partOf Σ0..*Reference(ResearchStudy)Part of larger study
... status ?!Σ1..1codeactive | 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 Σ0..1CodeableConcepttreatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
Binding: ResearchStudyPrimaryPurposeType (extensible): Codes for the main intent of the study.

... phase Σ0..1CodeableConceptn-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 Σ0..*CodeableConceptClassifications 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..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ0..*CodingCode defined by a terminology system

Required Pattern: At least the following
..... id0..1idUnique id for inter-element referencing
..... extension0..*ExtensionAdditional content defined by implementations
..... system1..1uriIdentity of the terminology system
Fixed Value: https://nih-ncpi.github.io/ncpi-fhir-ig
..... version0..1stringVersion of the system - if relevant
..... code1..1codeSymbol in syntax defined by the system
Fixed Value: StudyCohort
..... display1..1stringRepresentation defined by the system
Fixed Value: Study Cohort
..... userSelected0..1booleanIf this coding was chosen directly by the user
.... text Σ0..1stringPlain text representation of the concept
... focus Σ0..*CodeableConceptDrugs, devices, etc. under study
Binding: (unbound) (example): Codes for medications, devices and other interventions.


... condition Σ0..*CodeableConceptCondition being studied
Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis.


... contact Σ0..*ContactDetailContact details for the study
... relatedArtifact 0..*RelatedArtifactReferences and dependencies
... keyword Σ0..*CodeableConceptUsed to search for the study
Binding: (unbound) (example): Words associated with the study that may be useful in discovery.


... location Σ0..*CodeableConceptGeographic region(s) for study
Binding: Jurisdiction ValueSet (extensible): Countries and regions within which this artifact is targeted for use.


... description 0..1markdownWhat this is study doing
... enrollment Σ1..*Reference(NCPI Study Group)Inclusion & exclusion criteria
... period Σ0..1PeriodWhen the study began and ended
... sponsor Σ0..1Reference(Organization)Organization that initiates and is legally responsible for the study
... principalInvestigator Σ0..1Reference(Practitioner | PractitionerRole)Researcher who oversees multiple aspects of the study
... site Σ0..*Reference(Location)Facility where study activities are conducted
... reasonStopped Σ0..1CodeableConceptaccrual-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..*AnnotationComments made about the study
... arm 0..*BackboneElementDefined path through the study for a subject
.... 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
.... name 1..1stringLabel for study arm
.... type 0..1CodeableConceptCategorization of study arm
.... description 0..1stringShort explanation of study path
... objective 0..*BackboneElementA goal for the study
.... 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
.... name 0..1stringLabel for the objective
.... type 0..1CodeableConceptprimary | secondary | exploratory
Binding: ResearchStudyObjectiveType (preferred): Codes for the kind of study objective.


doco Documentation for this format

 

Other representations of profile: CSV, Excel, Schematron

Terminology Bindings

PathConformanceValueSet
ResearchStudy.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
ResearchStudy.statusrequiredResearchStudyStatus
ResearchStudy.primaryPurposeTypeextensibleResearchStudyPrimaryPurposeType
ResearchStudy.phaseexampleResearchStudyPhase
ResearchStudy.categoryexample
ResearchStudy.focusexample
ResearchStudy.conditionexampleCondition/Problem/DiagnosisCodes
ResearchStudy.keywordexample
ResearchStudy.locationextensibleJurisdiction ValueSet
ResearchStudy.reasonStoppedexampleResearchStudyReasonStopped
ResearchStudy.objective.typepreferredResearchStudyObjectiveType

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()

Notes:

Each NCPI Research must have at least 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. Additional Study Groups can be present indicating relevant groupings of subjects, such as for different consent groups.

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.