Key Guidelines

The NCPI File profile is based on the standard resource type, DocumentReference and is intended to represent the files associated with a participant in a research study.

Added Profile Restrictions

In order to ensure that our resources are interoperable across studies, we have employed a number of restrictions that should make consuming Patient resources more consistent.

• participantID should be a globally unique identifier associated with the patient. This practice is intended to make constructing queries for the same patient compatible across different servers (such as QA vs PROD) but also to make the resource URLs more meaningful.

• fileExternalID should have all appropriate Identifiers with a meaningful system/value pair. Such identifiers may include DbGAP accession IDs, global and external IDs, etc.

• format and relatedFile.type should use EDAM terminology (i.e., codes) when available. Other file type code systems are allowed if a suitable EDAM code does not exist.

Recommended Practices

Providing as much information about a file and file metatdata will help individuals using this IG to understand the details and limits of information conveyed about a file.

FHIR Mappings

The following fields from the shared data model are to be mapped to the NCPI File as shown below:

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

This structure is derived from DocumentReference

Name	Flags	Card.	Type	Description & Constraints
DocumentReference		0..*	DocumentReference	A reference to a document
Slices for extension		2..*	Extension	Extension Slice: Unordered, Open by value:url
file-format		1..1	CodeableConcept	The file format used (EDAM is preferred) URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/file-format Binding: http://edamontology.org (extensible)
location-access		0..*	Reference()	If present, only those under the specific Access Policy can access the file in this location. URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/location-access
file-size		1..1	Quantity	Indicate the size of the file in reference URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/file-size
hash		0..*	(Complex)	Provides a list of hashes for confirming file transfers URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/hash-extension
content-version		0..1	string	The version of the content in the file URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/content-version
identifier		1..*	Identifier	A related external file ID
type		0..1	CodeableConcept	The type of data contained in this file. Binding: Enumerations for the EDAM ontology (extensible)
subject		1..1	Reference(Patient | Practitioner | Group | Device)	The participant(s) for whom this file contains data (i.e., ParticipantID)
description		0..1	string	A description of the file
content
attachment
url		1..1	url	The URI at which this data can be accessed
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
DocumentReference.type	extensible	EDAMOntologyTerms (a valid code from http://edamontology.org) https://nih-ncpi.github.io/ncpi-fhir-ig-2/ValueSet/edam-ontology-terms from this IG

Name	Flags	Card.	Type	Description & Constraints
DocumentReference		0..*	DocumentReference	A reference to a document
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
Slices for extension		2..*	Extension	Extension Slice: Unordered, Open by value:url
file-format		1..1	CodeableConcept	The file format used (EDAM is preferred) URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/file-format Binding: http://edamontology.org (extensible)
location-access		0..*	Reference()	If present, only those under the specific Access Policy can access the file in this location. URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/location-access
file-size		1..1	Quantity	Indicate the size of the file in reference URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/file-size
hash		0..*	(Complex)	Provides a list of hashes for confirming file transfers URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/hash-extension
content-version		0..1	string	The version of the content in the file URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/content-version
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	1..*	Identifier	A related external file ID
status	?!Σ	1..1	code	current | superseded | entered-in-error Binding: DocumentReferenceStatus (required): The status of the document reference.
type	Σ	0..1	CodeableConcept	The type of data contained in this file. Binding: Enumerations for the EDAM ontology (extensible)
subject	Σ	1..1	Reference(Patient | Practitioner | Group | Device)	The participant(s) for whom this file contains data (i.e., ParticipantID)
description	Σ	0..1	string	A description of the file
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
url	Σ	1..1	url	The URI at which this data can be accessed Example General: http://www.acme.com/logo-small.png
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
DocumentReference.status	required	DocumentReferenceStatus http://hl7.org/fhir/ValueSet/document-reference-status|4.3.0 from the FHIR Standard
DocumentReference.type	extensible	EDAMOntologyTerms (a valid code from http://edamontology.org) https://nih-ncpi.github.io/ncpi-fhir-ig-2/ValueSet/edam-ontology-terms from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
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.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	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()
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
DocumentReference		0..*	DocumentReference	A reference to a document
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: CommonLanguages (preferred): IETF language tag Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources dom-r4b: Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems
Slices for extension		2..*	Extension	Extension Slice: Unordered, Open by value:url
file-format		1..1	CodeableConcept	The file format used (EDAM is preferred) URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/file-format Binding: http://edamontology.org (extensible)
location-access		0..*	Reference()	If present, only those under the specific Access Policy can access the file in this location. URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/location-access
file-size		1..1	Quantity	Indicate the size of the file in reference URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/file-size
hash		0..*	(Complex)	Provides a list of hashes for confirming file transfers URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/hash-extension
content-version		0..1	string	The version of the content in the file URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/content-version
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
masterIdentifier	Σ	0..1	Identifier	Master Version Specific Identifier
identifier	Σ	1..*	Identifier	A related external file ID
status	?!Σ	1..1	code	current | superseded | entered-in-error Binding: DocumentReferenceStatus (required): The status of the document reference.
docStatus	Σ	0..1	code	preliminary | final | amended | entered-in-error Binding: CompositionStatus (required): Status of the underlying document.
type	Σ	0..1	CodeableConcept	The type of data contained in this file. Binding: Enumerations for the EDAM ontology (extensible)
category	Σ	0..*	CodeableConcept	Categorization of document Binding: DocumentClassValueSet (example): High-level kind of a clinical document at a macro level.
subject	Σ	1..1	Reference(Patient | Practitioner | Group | Device)	The participant(s) for whom this file contains data (i.e., ParticipantID)
date	Σ	0..1	instant	When this document reference was created
author	Σ	0..*	Reference(Practitioner | PractitionerRole | Organization | Device | Patient | RelatedPerson)	Who and/or what authored the document
authenticator		0..1	Reference(Practitioner | PractitionerRole | Organization)	Who/what authenticated 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	code	replaces | transforms | signs | appends Binding: DocumentRelationshipType (required): The type of relationship between documents.
target	Σ	1..1	Reference(DocumentReference)	Target of the relationship
description	Σ	0..1	string	A description of the file
securityLabel	Σ	0..*	CodeableConcept	Document security-tags Binding: All Security Labels (extensible): 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
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
contentType	Σ	0..1	code	Mime type of the content, with charset etc. Binding: Mime Types (required): BCP 13 (RFCs 2045, 2046, 2047, 4288, 4289 and 2049) Example General: text/plain; charset=UTF-8, image/png
language	Σ	0..1	code	Human language of the content (BCP-47) Binding: CommonLanguages (preferred): IETF language tag Additional Bindings Purpose AllLanguages Max Binding Example General: en-AU
data		0..1	base64Binary	Data inline, base64ed
url	Σ	1..1	url	The URI at which this data can be accessed Example General: http://www.acme.com/logo-small.png
size	Σ	0..1	unsignedInt	Number of bytes of content (if url provided)
hash	Σ	0..1	base64Binary	Hash of the data (sha-1, base64ed)
title	Σ	0..1	string	Label to display in place of the data Example General: Official Corporate Logo
creation	Σ	0..1	dateTime	Date attachment was first created
format	Σ	0..1	Coding	Format/content rules for the document Binding: DocumentReferenceFormatCodeSet (preferred): Document Format Codes.
context	Σ	0..1	BackboneElement	Clinical context of 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
encounter		0..*	Reference(Encounter | EpisodeOfCare)	Context of the document content
event		0..*	CodeableConcept	Main clinical acts documented Binding: v3 Code System ActCode (example): This list of codes represents the main clinical acts being documented.
period	Σ	0..1	Period	Time of service that is being documented
facilityType		0..1	CodeableConcept	Kind of facility where patient was seen Binding: FacilityTypeCodeValueSet (example): XDS Facility Type.
practiceSetting		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).
sourcePatientInfo		0..1	Reference(Patient)	Patient demographics from source
related		0..*	Reference(Resource)	Related identifiers or resources
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
DocumentReference.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
DocumentReference.status	required	DocumentReferenceStatus http://hl7.org/fhir/ValueSet/document-reference-status|4.3.0 from the FHIR Standard
DocumentReference.docStatus	required	CompositionStatus http://hl7.org/fhir/ValueSet/composition-status|4.3.0 from the FHIR Standard
DocumentReference.type	extensible	EDAMOntologyTerms (a valid code from http://edamontology.org) https://nih-ncpi.github.io/ncpi-fhir-ig-2/ValueSet/edam-ontology-terms from this IG
DocumentReference.category	example	DocumentClassValueSet http://hl7.org/fhir/ValueSet/doc-classcodes from the FHIR Standard
DocumentReference.relatesTo.code	required	DocumentRelationshipType http://hl7.org/fhir/ValueSet/document-relationship-type|4.3.0 from the FHIR Standard
DocumentReference.securityLabel	extensible	All Security Labels http://hl7.org/fhir/ValueSet/security-labels from the FHIR Standard
DocumentReference.content.attachment.contentType	required	Mime Types (a valid code from urn:ietf:bcp:13) http://hl7.org/fhir/ValueSet/mimetypes|4.3.0 from the FHIR Standard
DocumentReference.content.attachment.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
DocumentReference.content.format	preferred	DocumentReferenceFormatCodeSet (a valid code from http://ihe.net/fhir/ValueSet/IHE.FormatCode.codesystem) http://hl7.org/fhir/ValueSet/formatcodes from the FHIR Standard
DocumentReference.context.event	example	ActCode http://terminology.hl7.org/ValueSet/v3-ActCode
DocumentReference.context.facilityType	example	FacilityTypeCodeValueSet http://hl7.org/fhir/ValueSet/c80-facilitycodes from the FHIR Standard
DocumentReference.context.practiceSetting	example	PracticeSettingCodeValueSet http://hl7.org/fhir/ValueSet/c80-practice-codes from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
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.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	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()
dom-r4b	warning	DocumentReference.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()

Differential View

This structure is derived from DocumentReference

Name	Flags	Card.	Type	Description & Constraints
DocumentReference		0..*	DocumentReference	A reference to a document
Slices for extension		2..*	Extension	Extension Slice: Unordered, Open by value:url
file-format		1..1	CodeableConcept	The file format used (EDAM is preferred) URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/file-format Binding: http://edamontology.org (extensible)
location-access		0..*	Reference()	If present, only those under the specific Access Policy can access the file in this location. URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/location-access
file-size		1..1	Quantity	Indicate the size of the file in reference URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/file-size
hash		0..*	(Complex)	Provides a list of hashes for confirming file transfers URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/hash-extension
content-version		0..1	string	The version of the content in the file URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/content-version
identifier		1..*	Identifier	A related external file ID
type		0..1	CodeableConcept	The type of data contained in this file. Binding: Enumerations for the EDAM ontology (extensible)
subject		1..1	Reference(Patient | Practitioner | Group | Device)	The participant(s) for whom this file contains data (i.e., ParticipantID)
description		0..1	string	A description of the file
content
attachment
url		1..1	url	The URI at which this data can be accessed
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
DocumentReference.type	extensible	EDAMOntologyTerms (a valid code from http://edamontology.org) https://nih-ncpi.github.io/ncpi-fhir-ig-2/ValueSet/edam-ontology-terms from this IG

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
DocumentReference		0..*	DocumentReference	A reference to a document
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
Slices for extension		2..*	Extension	Extension Slice: Unordered, Open by value:url
file-format		1..1	CodeableConcept	The file format used (EDAM is preferred) URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/file-format Binding: http://edamontology.org (extensible)
location-access		0..*	Reference()	If present, only those under the specific Access Policy can access the file in this location. URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/location-access
file-size		1..1	Quantity	Indicate the size of the file in reference URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/file-size
hash		0..*	(Complex)	Provides a list of hashes for confirming file transfers URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/hash-extension
content-version		0..1	string	The version of the content in the file URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/content-version
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	1..*	Identifier	A related external file ID
status	?!Σ	1..1	code	current | superseded | entered-in-error Binding: DocumentReferenceStatus (required): The status of the document reference.
type	Σ	0..1	CodeableConcept	The type of data contained in this file. Binding: Enumerations for the EDAM ontology (extensible)
subject	Σ	1..1	Reference(Patient | Practitioner | Group | Device)	The participant(s) for whom this file contains data (i.e., ParticipantID)
description	Σ	0..1	string	A description of the file
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
url	Σ	1..1	url	The URI at which this data can be accessed Example General: http://www.acme.com/logo-small.png
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
DocumentReference.status	required	DocumentReferenceStatus http://hl7.org/fhir/ValueSet/document-reference-status|4.3.0 from the FHIR Standard
DocumentReference.type	extensible	EDAMOntologyTerms (a valid code from http://edamontology.org) https://nih-ncpi.github.io/ncpi-fhir-ig-2/ValueSet/edam-ontology-terms from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
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.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	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()
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
DocumentReference		0..*	DocumentReference	A reference to a document
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: CommonLanguages (preferred): IETF language tag Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources dom-r4b: Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems
Slices for extension		2..*	Extension	Extension Slice: Unordered, Open by value:url
file-format		1..1	CodeableConcept	The file format used (EDAM is preferred) URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/file-format Binding: http://edamontology.org (extensible)
location-access		0..*	Reference()	If present, only those under the specific Access Policy can access the file in this location. URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/location-access
file-size		1..1	Quantity	Indicate the size of the file in reference URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/file-size
hash		0..*	(Complex)	Provides a list of hashes for confirming file transfers URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/hash-extension
content-version		0..1	string	The version of the content in the file URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/content-version
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
masterIdentifier	Σ	0..1	Identifier	Master Version Specific Identifier
identifier	Σ	1..*	Identifier	A related external file ID
status	?!Σ	1..1	code	current | superseded | entered-in-error Binding: DocumentReferenceStatus (required): The status of the document reference.
docStatus	Σ	0..1	code	preliminary | final | amended | entered-in-error Binding: CompositionStatus (required): Status of the underlying document.
type	Σ	0..1	CodeableConcept	The type of data contained in this file. Binding: Enumerations for the EDAM ontology (extensible)
category	Σ	0..*	CodeableConcept	Categorization of document Binding: DocumentClassValueSet (example): High-level kind of a clinical document at a macro level.
subject	Σ	1..1	Reference(Patient | Practitioner | Group | Device)	The participant(s) for whom this file contains data (i.e., ParticipantID)
date	Σ	0..1	instant	When this document reference was created
author	Σ	0..*	Reference(Practitioner | PractitionerRole | Organization | Device | Patient | RelatedPerson)	Who and/or what authored the document
authenticator		0..1	Reference(Practitioner | PractitionerRole | Organization)	Who/what authenticated 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	code	replaces | transforms | signs | appends Binding: DocumentRelationshipType (required): The type of relationship between documents.
target	Σ	1..1	Reference(DocumentReference)	Target of the relationship
description	Σ	0..1	string	A description of the file
securityLabel	Σ	0..*	CodeableConcept	Document security-tags Binding: All Security Labels (extensible): 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
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
contentType	Σ	0..1	code	Mime type of the content, with charset etc. Binding: Mime Types (required): BCP 13 (RFCs 2045, 2046, 2047, 4288, 4289 and 2049) Example General: text/plain; charset=UTF-8, image/png
language	Σ	0..1	code	Human language of the content (BCP-47) Binding: CommonLanguages (preferred): IETF language tag Additional Bindings Purpose AllLanguages Max Binding Example General: en-AU
data		0..1	base64Binary	Data inline, base64ed
url	Σ	1..1	url	The URI at which this data can be accessed Example General: http://www.acme.com/logo-small.png
size	Σ	0..1	unsignedInt	Number of bytes of content (if url provided)
hash	Σ	0..1	base64Binary	Hash of the data (sha-1, base64ed)
title	Σ	0..1	string	Label to display in place of the data Example General: Official Corporate Logo
creation	Σ	0..1	dateTime	Date attachment was first created
format	Σ	0..1	Coding	Format/content rules for the document Binding: DocumentReferenceFormatCodeSet (preferred): Document Format Codes.
context	Σ	0..1	BackboneElement	Clinical context of 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
encounter		0..*	Reference(Encounter | EpisodeOfCare)	Context of the document content
event		0..*	CodeableConcept	Main clinical acts documented Binding: v3 Code System ActCode (example): This list of codes represents the main clinical acts being documented.
period	Σ	0..1	Period	Time of service that is being documented
facilityType		0..1	CodeableConcept	Kind of facility where patient was seen Binding: FacilityTypeCodeValueSet (example): XDS Facility Type.
practiceSetting		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).
sourcePatientInfo		0..1	Reference(Patient)	Patient demographics from source
related		0..*	Reference(Resource)	Related identifiers or resources
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
DocumentReference.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
DocumentReference.status	required	DocumentReferenceStatus http://hl7.org/fhir/ValueSet/document-reference-status|4.3.0 from the FHIR Standard
DocumentReference.docStatus	required	CompositionStatus http://hl7.org/fhir/ValueSet/composition-status|4.3.0 from the FHIR Standard
DocumentReference.type	extensible	EDAMOntologyTerms (a valid code from http://edamontology.org) https://nih-ncpi.github.io/ncpi-fhir-ig-2/ValueSet/edam-ontology-terms from this IG
DocumentReference.category	example	DocumentClassValueSet http://hl7.org/fhir/ValueSet/doc-classcodes from the FHIR Standard
DocumentReference.relatesTo.code	required	DocumentRelationshipType http://hl7.org/fhir/ValueSet/document-relationship-type|4.3.0 from the FHIR Standard
DocumentReference.securityLabel	extensible	All Security Labels http://hl7.org/fhir/ValueSet/security-labels from the FHIR Standard
DocumentReference.content.attachment.contentType	required	Mime Types (a valid code from urn:ietf:bcp:13) http://hl7.org/fhir/ValueSet/mimetypes|4.3.0 from the FHIR Standard
DocumentReference.content.attachment.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
DocumentReference.content.format	preferred	DocumentReferenceFormatCodeSet (a valid code from http://ihe.net/fhir/ValueSet/IHE.FormatCode.codesystem) http://hl7.org/fhir/ValueSet/formatcodes from the FHIR Standard
DocumentReference.context.event	example	ActCode http://terminology.hl7.org/ValueSet/v3-ActCode
DocumentReference.context.facilityType	example	FacilityTypeCodeValueSet http://hl7.org/fhir/ValueSet/c80-facilitycodes from the FHIR Standard
DocumentReference.context.practiceSetting	example	PracticeSettingCodeValueSet http://hl7.org/fhir/ValueSet/c80-practice-codes from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
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.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	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()
dom-r4b	warning	DocumentReference.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 DocumentReference

Summary

Mandatory: 5 elements

Extensions

This structure refers to these extensions:

• https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/file-format
• https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/location-access
• https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/file-size
• https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/hash-extension
• https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/content-version