NCPI FHIR Implementation Guide v2 - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
Resource Profile: NCPI Research Study
| Official URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/ncpi-research-study | Version: 0.1.0 | |||
| Draft as of 2024-09-26 | Computable Name: NcpiResearchStudy | |||
The NCPI Research Study FHIR resource represents an individual research effort and acts as a grouper or “container” for that effort’s study participants and their related data files.
The NCPI Research Study is based upon the core HL7 FHIR ResearchStudy resource (R4) and acts as the umbrella for grouping and describing all other study resources..
For the purposes of interoperability, this guide includes recommended practices for the shared 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:
- 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.
- enrollment must contain 1 reference of type, Study Group.
- category must contain the Coding from NCPI StudyCohort.
- principalInvestigator must be of type Practitioner if present. (Note: we are using practitioner to maintain consistency with existing FHIR structures.)
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.
Shared Data Elements
| NCPI Shared Data Elements | HL7 FHIR (R4) Element | Recommended or Optional | Notes | |
|---|---|---|---|---|
| Study description | description | Recommended | ||
| Disease/focus | condition | Recommended | Should also have one or more Codings provided, indicating the disease or phenotypes that were interrogated during the study’s execution | |
| Attribution | relatedArtifact | Recommended | This can include, but not limited to; principal investigators, grant numbers, etc. | |
| Study weblinks | relatedArtifact | Optional | These elements fall under the StudyDescription element located in the Added Profile Restrictions section of this document. | |
| Study design | studyDesign | Optional | These elements fall under the StudyDescription element located in the Added Profile Restrictions section of this document. | |
| Study type | studyDesign | Optional | These elements fall under the StudyDescription element located in the Added Profile Restrictions section of this document. | |
| Citation | relatedArtifact | Optional | ||
| Study documents | relatedArtifact | Optional |
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.
Additional Study Groups may be included to describe various aspects of the study’s population.
Notes:
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 researchers 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.
Identifiers - Best Practices
Provide meaningful systems at all times
System uris are important for identifying the origin of an identifier. These uris should be consistent across all groups which utilize these identifiers. Some important systems to note include:
| Organization | System | Comment |
|---|---|---|
| DbGAP | https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id= | For DbGAP Research Studies, this recommended system, when combined with the value would constitute a valid URL for the study. |
For those identifiers that have been defined by the investigators and collaborators, the system should be unique to the Research Study and may be defined by those responsible for the ETL itself.
Utilize 'use' Property
The Identifier datatype provides a use property which is used to indicate which identifier is official and secondary (among others) and should be used where appropriate. It is strongly recommended that the most visible external identifier be marked as official.
Common Data Model Mappings
The following represents the mapping from the Logical Research Study model to this NCPI Research Study FHIR profile.
| NCPI Shared Data Elements | FHIR Resource Mapping | Note |
| persistentIdentifier | identifier | System should be provided for each identifier which clearly indicates the identifier's origin |
| parentStudy | partOf | |
| name | title | The "Formal Title" will be stored as title |
| or name | relatedArtifact | All other names will be recorded as relatedArtifacts |
| description | description | |
| website | relatedArtifact.url | relatedArtifact.type = 'documentation' and url will record the actual website URL |
| studyFocus | focus | |
| additionalDocumentation | relatedArtifact | There should be some sort of guidance about how to designate the different possible documents listed here |
| consortium | extension[associatedParty] | R5 provides a more inclusive option for sponsor, investigators, collaborators etcs. I recommend using an extension to eumulate the new approach |
| acknowledgements | extension[associatedParty] | R5 provides a more inclusive option for sponsor, investigators, collaborators etcs. I recommend using an extension to eumulate the new approach |
| personnel | extension[associatedPart] | R5 provides a more inclusive option for sponsor, investigators, collaborators etcs. I recommend using an extension to eumulate the new approach |
Usage:
- Examples for this Resource Profile: ResearchStudy/kf-research-study-cbtn and ResearchStudy/research-study-gregor
Formal Views of Profile Content
Description of Profiles, Differentials, Snapshots and how the different presentations work.
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 | Study Design and Study Type URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-design Binding: https://hl7.org/fhir/valueset-study-design.html (example) | |
| result |
0..* | Reference(Citation) | Link to results generated during the study. URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-result | |
| associatedParty |
0..* | (Complex) | Research Study Associated Party URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-associated-party | |
 acknowledgement |
0..* | markdown | URL describing the policy restrictions in detail. URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-acknowledgement | |
  identifier |
1..* | Identifier | External facing, globally unique identifiers. When providing more than one identifier, researchers should indicate the 'official' identifier by assigning 'official' to that identifier's use property. | |
| title |
0..1 | string | Study's formal title. | |
| category |
||||
 coding |
0..* | Coding | Indicate this is an NCPI Research Study 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-2/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 | |
| focus |
0..* | CodeableConcept | The primary, non-disease focus(es) of the study. This can include terms related to intervention, drug, device, or other focus. | |
| condition |
0..* | CodeableConcept | The primary focus(es) of the study. This is specific to the disease. MeSH terms are preferred. | |
| relatedArtifact |
0..* | RelatedArtifact | Attribution, Study Weblinks, Citation, Study Documents, etc. | |
| description |
0..1 | markdown | Study Description (Recommended) | |
| 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 | Study Design and Study Type URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-design Binding: https://hl7.org/fhir/valueset-study-design.html (example) | |
| result |
0..* | Reference(Citation) | Link to results generated during the study. URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-result | |
| associatedParty |
0..* | (Complex) | Research Study Associated Party URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-associated-party | |
| acknowledgement |
0..* | markdown | URL describing the policy restrictions in detail. URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-acknowledgement | |
 modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored |
 identifier |
Σ | 1..* | Identifier | External facing, globally unique identifiers. When providing more than one identifier, researchers should indicate the 'official' identifier by assigning 'official' to that identifier's use property. |
| title |
Σ | 0..1 | string | Study's formal title. |
| 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. |
| focus |
Σ | 0..* | CodeableConcept | The primary, non-disease focus(es) of the study. This can include terms related to intervention, drug, device, or other focus. Binding Description (No ValueSet): (example): Codes for medications, devices and other interventions. |
| condition |
Σ | 0..* | CodeableConcept | The primary focus(es) of the study. This is specific to the disease. MeSH terms are preferred. Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis. |
| relatedArtifact |
0..* | RelatedArtifact | Attribution, Study Weblinks, Citation, Study Documents, etc. | |
| description |
0..1 | markdown | Study Description (Recommended) | |
| Documentation for this format | ||||
Terminology Bindings
| Path | Conformance | ValueSet | URI |
| ResearchStudy.status | required | ResearchStudyStatushttp://hl7.org/fhir/ValueSet/research-study-status|4.3.0from the FHIR Standard | |
| ResearchStudy.focus | example | ||
| ResearchStudy.condition | example | Condition/Problem/DiagnosisCodeshttp://hl7.org/fhir/ValueSet/condition-codefrom the FHIR Standard |
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.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 | 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): IETF language tag
| |||||
| 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 | |||||
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| studyDesign |
0..* | CodeableConcept | Study Design and Study Type URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-design Binding: https://hl7.org/fhir/valueset-study-design.html (example) | |||||
| result |
0..* | Reference(Citation) | Link to results generated during the study. URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-result | |||||
| associatedParty |
0..* | (Complex) | Research Study Associated Party URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-associated-party | |||||
| acknowledgement |
0..* | markdown | URL describing the policy restrictions in detail. URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-acknowledgement | |||||
| modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier |
Σ | 1..* | Identifier | External facing, globally unique identifiers. When providing more than one identifier, researchers should indicate the 'official' identifier by assigning 'official' to that identifier's use property. | ||||
| title |
Σ | 0..1 | string | Study's formal title. | ||||
 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 Description (No ValueSet): (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc. | ||||
| id |
0..1 | id | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| coding |
Σ | 0..* | Coding | Indicate this is an NCPI Research Study 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-2/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 | The primary, non-disease focus(es) of the study. This can include terms related to intervention, drug, device, or other focus. Binding Description (No ValueSet): (example): Codes for medications, devices and other interventions. | ||||
| condition |
Σ | 0..* | CodeableConcept | The primary focus(es) of the study. This is specific to the disease. MeSH terms are preferred. Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis. | ||||
| contact |
Σ | 0..* | ContactDetail | Contact details for the study | ||||
| relatedArtifact |
0..* | RelatedArtifact | Attribution, Study Weblinks, Citation, Study Documents, etc. | |||||
| keyword |
Σ | 0..* | CodeableConcept | Used to search for the study Binding Description (No ValueSet): (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 | Study Description (Recommended) | |||||
| enrollment |
Σ | 0..* | Reference(Group) | Inclusion & exclusion criteria | ||||
| period |
Σ | 0..1 | Period | When the study began and ended | ||||
| sponsor |
Σ | 0..1 | Reference(Organization) | Organization that initiates and is legally responsible for the study | ||||
| principalInvestigator |
Σ | 0..1 | Reference(Practitioner | PractitionerRole) | 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 | URI | |||
| ResearchStudy.language | preferred | CommonLanguages
http://hl7.org/fhir/ValueSet/languagesfrom the FHIR Standard | ||||
| ResearchStudy.status | required | ResearchStudyStatushttp://hl7.org/fhir/ValueSet/research-study-status|4.3.0from the FHIR Standard | ||||
| ResearchStudy.primaryPurposeType | extensible | ResearchStudyPrimaryPurposeTypehttp://hl7.org/fhir/ValueSet/research-study-prim-purp-typefrom the FHIR Standard | ||||
| ResearchStudy.phase | example | ResearchStudyPhasehttp://hl7.org/fhir/ValueSet/research-study-phasefrom the FHIR Standard | ||||
| ResearchStudy.category | example | |||||
| ResearchStudy.focus | example | |||||
| ResearchStudy.condition | example | Condition/Problem/DiagnosisCodeshttp://hl7.org/fhir/ValueSet/condition-codefrom the FHIR Standard | ||||
| ResearchStudy.keyword | example | |||||
| ResearchStudy.location | extensible | Jurisdiction ValueSethttp://hl7.org/fhir/ValueSet/jurisdictionfrom the FHIR Standard | ||||
| ResearchStudy.reasonStopped | example | ResearchStudyReasonStoppedhttp://hl7.org/fhir/ValueSet/research-study-reason-stoppedfrom the FHIR Standard | ||||
| ResearchStudy.objective.type | preferred | ResearchStudyObjectiveTypehttp://hl7.org/fhir/ValueSet/research-study-objective-typefrom the FHIR Standard |
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.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 | 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() | |
| dom-r4b | warning | ResearchStudy.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() |
This structure is derived from ResearchStudy
Summary
Mandatory: 1 element
Extensions
This structure refers to these extensions:
- https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-design
- https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-result
- https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-associated-party
- https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-acknowledgement
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 | Study Design and Study Type URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-design Binding: https://hl7.org/fhir/valueset-study-design.html (example) | |
| result |
0..* | Reference(Citation) | Link to results generated during the study. URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-result | |
| associatedParty |
0..* | (Complex) | Research Study Associated Party URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-associated-party | |
| acknowledgement |
0..* | markdown | URL describing the policy restrictions in detail. URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-acknowledgement | |
| identifier |
1..* | Identifier | External facing, globally unique identifiers. When providing more than one identifier, researchers should indicate the 'official' identifier by assigning 'official' to that identifier's use property. | |
| title |
0..1 | string | Study's formal title. | |
| category |
||||
| coding |
0..* | Coding | Indicate this is an NCPI Research Study 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-2/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 | |
| focus |
0..* | CodeableConcept | The primary, non-disease focus(es) of the study. This can include terms related to intervention, drug, device, or other focus. | |
| condition |
0..* | CodeableConcept | The primary focus(es) of the study. This is specific to the disease. MeSH terms are preferred. | |
| relatedArtifact |
0..* | RelatedArtifact | Attribution, Study Weblinks, Citation, Study Documents, etc. | |
| description |
0..1 | markdown | Study Description (Recommended) | |
| 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 | Study Design and Study Type URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-design Binding: https://hl7.org/fhir/valueset-study-design.html (example) | |
| result |
0..* | Reference(Citation) | Link to results generated during the study. URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-result | |
| associatedParty |
0..* | (Complex) | Research Study Associated Party URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-associated-party | |
| acknowledgement |
0..* | markdown | URL describing the policy restrictions in detail. URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-acknowledgement | |
| modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored |
| identifier |
Σ | 1..* | Identifier | External facing, globally unique identifiers. When providing more than one identifier, researchers should indicate the 'official' identifier by assigning 'official' to that identifier's use property. |
| title |
Σ | 0..1 | string | Study's formal title. |
| 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. |
| focus |
Σ | 0..* | CodeableConcept | The primary, non-disease focus(es) of the study. This can include terms related to intervention, drug, device, or other focus. Binding Description (No ValueSet): (example): Codes for medications, devices and other interventions. |
| condition |
Σ | 0..* | CodeableConcept | The primary focus(es) of the study. This is specific to the disease. MeSH terms are preferred. Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis. |
| relatedArtifact |
0..* | RelatedArtifact | Attribution, Study Weblinks, Citation, Study Documents, etc. | |
| description |
0..1 | markdown | Study Description (Recommended) | |
| Documentation for this format | ||||
Terminology Bindings
| Path | Conformance | ValueSet | URI |
| ResearchStudy.status | required | ResearchStudyStatushttp://hl7.org/fhir/ValueSet/research-study-status|4.3.0from the FHIR Standard | |
| ResearchStudy.focus | example | ||
| ResearchStudy.condition | example | Condition/Problem/DiagnosisCodeshttp://hl7.org/fhir/ValueSet/condition-codefrom the FHIR Standard |
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.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 | 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): IETF language tag
| |||||
| 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 | |||||
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| studyDesign |
0..* | CodeableConcept | Study Design and Study Type URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-design Binding: https://hl7.org/fhir/valueset-study-design.html (example) | |||||
| result |
0..* | Reference(Citation) | Link to results generated during the study. URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-result | |||||
| associatedParty |
0..* | (Complex) | Research Study Associated Party URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-associated-party | |||||
| acknowledgement |
0..* | markdown | URL describing the policy restrictions in detail. URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-acknowledgement | |||||
| modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier |
Σ | 1..* | Identifier | External facing, globally unique identifiers. When providing more than one identifier, researchers should indicate the 'official' identifier by assigning 'official' to that identifier's use property. | ||||
| title |
Σ | 0..1 | string | Study's formal title. | ||||
| 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 Description (No ValueSet): (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc. | ||||
| id |
0..1 | id | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| coding |
Σ | 0..* | Coding | Indicate this is an NCPI Research Study 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-2/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 | The primary, non-disease focus(es) of the study. This can include terms related to intervention, drug, device, or other focus. Binding Description (No ValueSet): (example): Codes for medications, devices and other interventions. | ||||
| condition |
Σ | 0..* | CodeableConcept | The primary focus(es) of the study. This is specific to the disease. MeSH terms are preferred. Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis. | ||||
| contact |
Σ | 0..* | ContactDetail | Contact details for the study | ||||
| relatedArtifact |
0..* | RelatedArtifact | Attribution, Study Weblinks, Citation, Study Documents, etc. | |||||
| keyword |
Σ | 0..* | CodeableConcept | Used to search for the study Binding Description (No ValueSet): (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 | Study Description (Recommended) | |||||
| enrollment |
Σ | 0..* | Reference(Group) | Inclusion & exclusion criteria | ||||
| period |
Σ | 0..1 | Period | When the study began and ended | ||||
| sponsor |
Σ | 0..1 | Reference(Organization) | Organization that initiates and is legally responsible for the study | ||||
| principalInvestigator |
Σ | 0..1 | Reference(Practitioner | PractitionerRole) | 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 | URI | |||
| ResearchStudy.language | preferred | CommonLanguages
http://hl7.org/fhir/ValueSet/languagesfrom the FHIR Standard | ||||
| ResearchStudy.status | required | ResearchStudyStatushttp://hl7.org/fhir/ValueSet/research-study-status|4.3.0from the FHIR Standard | ||||
| ResearchStudy.primaryPurposeType | extensible | ResearchStudyPrimaryPurposeTypehttp://hl7.org/fhir/ValueSet/research-study-prim-purp-typefrom the FHIR Standard | ||||
| ResearchStudy.phase | example | ResearchStudyPhasehttp://hl7.org/fhir/ValueSet/research-study-phasefrom the FHIR Standard | ||||
| ResearchStudy.category | example | |||||
| ResearchStudy.focus | example | |||||
| ResearchStudy.condition | example | Condition/Problem/DiagnosisCodeshttp://hl7.org/fhir/ValueSet/condition-codefrom the FHIR Standard | ||||
| ResearchStudy.keyword | example | |||||
| ResearchStudy.location | extensible | Jurisdiction ValueSethttp://hl7.org/fhir/ValueSet/jurisdictionfrom the FHIR Standard | ||||
| ResearchStudy.reasonStopped | example | ResearchStudyReasonStoppedhttp://hl7.org/fhir/ValueSet/research-study-reason-stoppedfrom the FHIR Standard | ||||
| ResearchStudy.objective.type | preferred | ResearchStudyObjectiveTypehttp://hl7.org/fhir/ValueSet/research-study-objective-typefrom the FHIR Standard |
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.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 | 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() | |
| dom-r4b | warning | ResearchStudy.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() |
This structure is derived from ResearchStudy
Summary
Mandatory: 1 element
Extensions
This structure refers to these extensions:
- https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-design
- https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-result
- https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-associated-party
- https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-acknowledgement
Other representations of profile: CSV, Excel, Schematron