Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot2 - STU 1 ballot International flag

Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions

Resource Profile: ResearchStudySupport

Official URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-support Version: 1.0.0-ballot2
Standards status: Trial-use Maturity Level: 1 Computable Name: ResearchStudySupport
Other Identifiers: OID:2.16.840.1.113883.4.642.40.44.42.132

Profile of DocumentReference for Evidence Based Medicine IG. The ResearchStudySupport Profile is used to classify the type of document used to support a research study.

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

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

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. DocumentReference C 0..* DocumentReference A reference to a document
Constraints: docRef-1, docRef-2
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... docStatus ?!Σ 0..1 code registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown
Binding: CompositionStatus (required): Status of the underlying document.
... type Σ 0..1 CodeableConcept Kind of document (LOINC if possible)
Binding: Research Study Document Types Value Set (extensible)
... context ΣC 0..* Reference(Appointment | Encounter | EpisodeOfCare) Encounter the document reference is part of
... content Σ 1..* BackboneElement Document referenced
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... attachment Σ 1..1 Attachment Where to access the document

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
DocumentReference.status Base required DocumentReferenceStatus 📍6.0.0-ballot3 FHIR Std.
DocumentReference.docStatus Base required Composition Status 📍6.0.0-ballot3 FHIR Std.
DocumentReference.type Base extensible Research Study Document Types Value Set 📦1.0.0-ballot2 This IG

Constraints

Id Grade Path(s) Description Expression
dom-2 error DocumentReference If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error DocumentReference 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.trace('id') in %resource.descendants().select(reference | as(uri))) or descendants().where(reference='#' | as(uri)='#').exists()).not()).trace('unmatched', id).empty()
dom-4 error DocumentReference 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 DocumentReference If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice DocumentReference A resource should have narrative for robust management text.`div`.exists()
docRef-1 warning DocumentReference facilityType SHALL only be present if context is not an encounter facilityType.empty() or context.where(resolve() is Encounter).empty()
docRef-2 warning DocumentReference practiceSetting SHALL only be present if context is not present practiceSetting.empty() or context.where(resolve() is Encounter).empty()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())

This structure is derived from DocumentReference

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. DocumentReference 0..* DocumentReference A reference to a document
... type 0..1 CodeableConcept Kind of document (LOINC if possible)
Binding: Research Study Document Types Value Set (extensible)

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
DocumentReference.type Base extensible Research Study Document Types Value Set 📦1.0.0-ballot2 This IG
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. DocumentReference C 0..* DocumentReference A reference to a document
Constraints: docRef-1, docRef-2
... 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: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
CommonLanguages Starter
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Business identifiers for the document
... version Σ 0..1 string An explicitly assigned identifier of a variation of the content in the DocumentReference
... basedOn 0..* Reference(Appointment | AppointmentResponse | CarePlan | Claim | CommunicationRequest | Contract | CoverageEligibilityRequest | DeviceRequest | EnrollmentRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | RequestOrchestration | ServiceRequest | SupplyRequest | VisionPrescription) Procedure that caused this media to be created
... status ?!Σ 1..1 code current | superseded | entered-in-error
Binding: DocumentReferenceStatus (required): The status of the document reference.
... docStatus ?!Σ 0..1 code registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown
Binding: CompositionStatus (required): Status of the underlying document.
... modality Σ 0..* CodeableConcept Imaging modality used
Binding: Modality . (extensible): Type of acquired data in the instance.
... type Σ 0..1 CodeableConcept Kind of document (LOINC if possible)
Binding: Research Study Document Types Value Set (extensible)
... category Σ 0..* CodeableConcept Categorization of document
Binding: ReferencedItemCategoryValueSet (example): High-level kind of document at a macro level.
... subject Σ 0..1 Reference(Resource) Who/what is the subject of the document
... context ΣC 0..* Reference(Appointment | Encounter | EpisodeOfCare) Encounter the document reference is part of
... event 0..* CodeableReference(Resource) Main clinical acts documented
Binding: v3 Code System ActCode (example): This list of codes represents the main clinical acts being documented.
... related 0..* Reference(Resource) Related identifiers or resources associated with the document reference
... bodySite Σ 0..* CodeableReference(BodyStructure) Body part included
Binding: SNOMEDCTBodyStructures (example): SNOMED CT Body site concepts
... facilityType C 0..1 CodeableConcept Kind of facility where patient was seen
Binding: FacilityTypeCodeValueSet (example): XDS Facility Type.
... practiceSetting C 0..1 CodeableConcept Additional details about where the content was created (e.g. clinical specialty)
Binding: PracticeSettingCodeValueSet (example): Additional details about where the content was created (e.g. clinical specialty).
... period Σ 0..1 Period Time of service that is being documented
... date Σ 0..1 dateTime When this document reference was created
... author Σ 0..* Reference(Practitioner | PractitionerRole | Organization | Device | Patient | RelatedPerson | CareTeam | Group) Who and/or what authored the document
... attester 0..* BackboneElement Attests to accuracy of the document
.... 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
.... mode 1..1 CodeableConcept personal | professional | legal | official
Binding: CompositionAttestationMode (preferred): The way in which a person authenticated a document.
.... time 0..1 dateTime When the document was attested
.... party 0..1 Reference(Patient | RelatedPerson | Practitioner | PractitionerRole | Organization | Group) Who attested the document
... custodian 0..1 Reference(Organization) Organization which maintains the document
... relatesTo Σ 0..* BackboneElement Relationships to other documents
.... 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 Σ 1..1 CodeableConcept The relationship type with another document
Binding: DocumentRelationshipType (extensible): The type of relationship between the documents.
.... target Σ 1..1 Reference(DocumentReference) Target of the relationship
... description Σ 0..1 markdown Human-readable description
... securityLabel Σ 0..* CodeableConcept Document security-tags
Binding: SecurityLabelExamples (example): Example Security Labels from the Healthcare Privacy and Security Classification System.
... content Σ 1..* BackboneElement Document referenced
.... 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
.... attachment Σ 1..1 Attachment Where to access the document
.... profile Σ 0..* BackboneElement Content profile rules for the document
..... 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
..... value[x] Σ 1..1 Code|uri|canonical
Binding: HL7 ValueSet of Format Codes for use with Document Sharing (preferred): Document Format Codes.
...... valueCoding Coding
...... valueUri uri
...... valueCanonical canonical(Any)

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
DocumentReference.language Base required All Languages 📍6.0.0-ballot3 FHIR Std.
DocumentReference.status Base required DocumentReferenceStatus 📍6.0.0-ballot3 FHIR Std.
DocumentReference.docStatus Base required Composition Status 📍6.0.0-ballot3 FHIR Std.
DocumentReference.modality Base extensible Modality . ⏿2025.3.20250714 tx.fhir.org
DocumentReference.type Base extensible Research Study Document Types Value Set 📦1.0.0-ballot2 This IG
DocumentReference.category Base example Referenced Item Category Value Set 📍6.0.0-ballot3 FHIR Std.
DocumentReference.event Base example v3 Code System ActCode 📦3.0.0 THO v6.5
DocumentReference.bodySite Base example SNOMED CT Body Structures 📍6.0.0-ballot3 FHIR Std.
DocumentReference.facilityType Base example Facility Type Code Value Set 📍6.0.0-ballot3 FHIR Std.
DocumentReference.practiceSetting Base example Practice Setting Code Value Set 📍6.0.0-ballot3 FHIR Std.
DocumentReference.attester.​mode Base preferred Composition Attestation Mode 📍6.0.0-ballot3 FHIR Std.
DocumentReference.relatesTo.​code Base extensible Document Relationship Type 📍6.0.0-ballot3 FHIR Std.
DocumentReference.securityLabel Base example Example set of Security Labels 📍6.0.0-ballot3 FHIR Std.
DocumentReference.content.​profile.value[x] Base preferred HL7 ValueSet of Format Codes for use with Document Sharing 📦2.1.0 THO v6.5

Constraints

Id Grade Path(s) Description Expression
dom-2 error DocumentReference If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error DocumentReference 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.trace('id') in %resource.descendants().select(reference | as(uri))) or descendants().where(reference='#' | as(uri)='#').exists()).not()).trace('unmatched', id).empty()
dom-4 error DocumentReference 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 DocumentReference If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice DocumentReference A resource should have narrative for robust management text.`div`.exists()
docRef-1 warning DocumentReference facilityType SHALL only be present if context is not an encounter facilityType.empty() or context.where(resolve() is Encounter).empty()
docRef-2 warning DocumentReference practiceSetting SHALL only be present if context is not present practiceSetting.empty() or context.where(resolve() is Encounter).empty()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())

This structure is derived from DocumentReference

Summary

Maturity: 1

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. DocumentReference C 0..* DocumentReference A reference to a document
Constraints: docRef-1, docRef-2
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... docStatus ?!Σ 0..1 code registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown
Binding: CompositionStatus (required): Status of the underlying document.
... type Σ 0..1 CodeableConcept Kind of document (LOINC if possible)
Binding: Research Study Document Types Value Set (extensible)
... context ΣC 0..* Reference(Appointment | Encounter | EpisodeOfCare) Encounter the document reference is part of
... content Σ 1..* BackboneElement Document referenced
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... attachment Σ 1..1 Attachment Where to access the document

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
DocumentReference.status Base required DocumentReferenceStatus 📍6.0.0-ballot3 FHIR Std.
DocumentReference.docStatus Base required Composition Status 📍6.0.0-ballot3 FHIR Std.
DocumentReference.type Base extensible Research Study Document Types Value Set 📦1.0.0-ballot2 This IG

Constraints

Id Grade Path(s) Description Expression
dom-2 error DocumentReference If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error DocumentReference 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.trace('id') in %resource.descendants().select(reference | as(uri))) or descendants().where(reference='#' | as(uri)='#').exists()).not()).trace('unmatched', id).empty()
dom-4 error DocumentReference 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 DocumentReference If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice DocumentReference A resource should have narrative for robust management text.`div`.exists()
docRef-1 warning DocumentReference facilityType SHALL only be present if context is not an encounter facilityType.empty() or context.where(resolve() is Encounter).empty()
docRef-2 warning DocumentReference practiceSetting SHALL only be present if context is not present practiceSetting.empty() or context.where(resolve() is Encounter).empty()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())

Differential View

This structure is derived from DocumentReference

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. DocumentReference 0..* DocumentReference A reference to a document
... type 0..1 CodeableConcept Kind of document (LOINC if possible)
Binding: Research Study Document Types Value Set (extensible)

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
DocumentReference.type Base extensible Research Study Document Types Value Set 📦1.0.0-ballot2 This IG

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. DocumentReference C 0..* DocumentReference A reference to a document
Constraints: docRef-1, docRef-2
... 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: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
CommonLanguages Starter
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Business identifiers for the document
... version Σ 0..1 string An explicitly assigned identifier of a variation of the content in the DocumentReference
... basedOn 0..* Reference(Appointment | AppointmentResponse | CarePlan | Claim | CommunicationRequest | Contract | CoverageEligibilityRequest | DeviceRequest | EnrollmentRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | RequestOrchestration | ServiceRequest | SupplyRequest | VisionPrescription) Procedure that caused this media to be created
... status ?!Σ 1..1 code current | superseded | entered-in-error
Binding: DocumentReferenceStatus (required): The status of the document reference.
... docStatus ?!Σ 0..1 code registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown
Binding: CompositionStatus (required): Status of the underlying document.
... modality Σ 0..* CodeableConcept Imaging modality used
Binding: Modality . (extensible): Type of acquired data in the instance.
... type Σ 0..1 CodeableConcept Kind of document (LOINC if possible)
Binding: Research Study Document Types Value Set (extensible)
... category Σ 0..* CodeableConcept Categorization of document
Binding: ReferencedItemCategoryValueSet (example): High-level kind of document at a macro level.
... subject Σ 0..1 Reference(Resource) Who/what is the subject of the document
... context ΣC 0..* Reference(Appointment | Encounter | EpisodeOfCare) Encounter the document reference is part of
... event 0..* CodeableReference(Resource) Main clinical acts documented
Binding: v3 Code System ActCode (example): This list of codes represents the main clinical acts being documented.
... related 0..* Reference(Resource) Related identifiers or resources associated with the document reference
... bodySite Σ 0..* CodeableReference(BodyStructure) Body part included
Binding: SNOMEDCTBodyStructures (example): SNOMED CT Body site concepts
... facilityType C 0..1 CodeableConcept Kind of facility where patient was seen
Binding: FacilityTypeCodeValueSet (example): XDS Facility Type.
... practiceSetting C 0..1 CodeableConcept Additional details about where the content was created (e.g. clinical specialty)
Binding: PracticeSettingCodeValueSet (example): Additional details about where the content was created (e.g. clinical specialty).
... period Σ 0..1 Period Time of service that is being documented
... date Σ 0..1 dateTime When this document reference was created
... author Σ 0..* Reference(Practitioner | PractitionerRole | Organization | Device | Patient | RelatedPerson | CareTeam | Group) Who and/or what authored the document
... attester 0..* BackboneElement Attests to accuracy of the document
.... 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
.... mode 1..1 CodeableConcept personal | professional | legal | official
Binding: CompositionAttestationMode (preferred): The way in which a person authenticated a document.
.... time 0..1 dateTime When the document was attested
.... party 0..1 Reference(Patient | RelatedPerson | Practitioner | PractitionerRole | Organization | Group) Who attested the document
... custodian 0..1 Reference(Organization) Organization which maintains the document
... relatesTo Σ 0..* BackboneElement Relationships to other documents
.... 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 Σ 1..1 CodeableConcept The relationship type with another document
Binding: DocumentRelationshipType (extensible): The type of relationship between the documents.
.... target Σ 1..1 Reference(DocumentReference) Target of the relationship
... description Σ 0..1 markdown Human-readable description
... securityLabel Σ 0..* CodeableConcept Document security-tags
Binding: SecurityLabelExamples (example): Example Security Labels from the Healthcare Privacy and Security Classification System.
... content Σ 1..* BackboneElement Document referenced
.... 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
.... attachment Σ 1..1 Attachment Where to access the document
.... profile Σ 0..* BackboneElement Content profile rules for the document
..... 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
..... value[x] Σ 1..1 Code|uri|canonical
Binding: HL7 ValueSet of Format Codes for use with Document Sharing (preferred): Document Format Codes.
...... valueCoding Coding
...... valueUri uri
...... valueCanonical canonical(Any)

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
DocumentReference.language Base required All Languages 📍6.0.0-ballot3 FHIR Std.
DocumentReference.status Base required DocumentReferenceStatus 📍6.0.0-ballot3 FHIR Std.
DocumentReference.docStatus Base required Composition Status 📍6.0.0-ballot3 FHIR Std.
DocumentReference.modality Base extensible Modality . ⏿2025.3.20250714 tx.fhir.org
DocumentReference.type Base extensible Research Study Document Types Value Set 📦1.0.0-ballot2 This IG
DocumentReference.category Base example Referenced Item Category Value Set 📍6.0.0-ballot3 FHIR Std.
DocumentReference.event Base example v3 Code System ActCode 📦3.0.0 THO v6.5
DocumentReference.bodySite Base example SNOMED CT Body Structures 📍6.0.0-ballot3 FHIR Std.
DocumentReference.facilityType Base example Facility Type Code Value Set 📍6.0.0-ballot3 FHIR Std.
DocumentReference.practiceSetting Base example Practice Setting Code Value Set 📍6.0.0-ballot3 FHIR Std.
DocumentReference.attester.​mode Base preferred Composition Attestation Mode 📍6.0.0-ballot3 FHIR Std.
DocumentReference.relatesTo.​code Base extensible Document Relationship Type 📍6.0.0-ballot3 FHIR Std.
DocumentReference.securityLabel Base example Example set of Security Labels 📍6.0.0-ballot3 FHIR Std.
DocumentReference.content.​profile.value[x] Base preferred HL7 ValueSet of Format Codes for use with Document Sharing 📦2.1.0 THO v6.5

Constraints

Id Grade Path(s) Description Expression
dom-2 error DocumentReference If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error DocumentReference 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.trace('id') in %resource.descendants().select(reference | as(uri))) or descendants().where(reference='#' | as(uri)='#').exists()).not()).trace('unmatched', id).empty()
dom-4 error DocumentReference 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 DocumentReference If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice DocumentReference A resource should have narrative for robust management text.`div`.exists()
docRef-1 warning DocumentReference facilityType SHALL only be present if context is not an encounter facilityType.empty() or context.where(resolve() is Encounter).empty()
docRef-2 warning DocumentReference practiceSetting SHALL only be present if context is not present practiceSetting.empty() or context.where(resolve() is Encounter).empty()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())

This structure is derived from DocumentReference

Summary

Maturity: 1

 

Other representations of profile: CSV, Excel, Schematron