Clinical Research Core Implementation Guide 0.3 - Continuous Build
The official URL for this profile is:
https://esource-consortium.github.io/fhir-clinical-research/cr-core-patient
This FHIR profile sets minimum expectations for the Patient resource to search / fetch basic demographic and administrative information associated with a patient on a clinical trial. It identifies which core elements, extensions, vocabularies and value sets SHALL be present in the resource when using this profile.
FHIR servers must ensure that all patient records are associated with a protocol, represented by the linkage of a Patient and a particular ResearchStudy through the ResearchSubject resource.
The following data-elements are mandatory (i.e data MUST be present). These are presented below in a simple human-readable explanation. Profile specific guidance and examples are provided as well. The Formal Profile Definition below provides the formal summary, definitions, and terminology requirements.
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from Patient
This structure is derived from Patient
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  Patient | I | 0..* | Information about an individual or animal receiving health care services | |
  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) Max Binding: AllLanguages | |
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |
 contained | 0..* | Resource | Contained, inline Resources | |
 extension | 0..* | Extension | Additional content defined by implementations | |
 modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
| identifier | SΣ | 1..* | Identifier | An identifier for this patient |
 id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required) |
| type | Σ | 0..1 | CodeableConcept | Description of identifier Binding: Identifier Type Codes (extensible) |
| system | SΣ | 0..1 | uri | The namespace for the identifier value Example General': http://www.acme.com/identifiers/patient |
| value | Σ | 0..1 | string | The value that is unique Example General': 123456 |
| period | Σ | 0..1 | Period | Time period when id is/was valid for use |
  assigner | Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) |
| active | ?!Σ | 0..1 | boolean | Whether this patient's record is in active use |
| gender | Σ | 0..1 | code | male | female | other | unknown Binding: AdministrativeGender (required) |
| birthDate | Σ | 0..1 | date | The date of birth for the individual |
 deceased[x] | ?!Σ | 0..1 | boolean, dateTime | Indicates if the individual is deceased or not |
| maritalStatus | 0..1 | CodeableConcept | Marital (civil) status of a patient Binding: Marital Status Codes (extensible) | |
| multipleBirth[x] | 0..1 | boolean, integer | Whether patient is part of a multiple birth | |
| contact | I | 0..* | BackboneElement | A contact party (e.g. guardian, partner, friend) for the patient pat-1: SHALL at least contain a contact's details or a reference to an organization |
| 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 |
| relationship | 0..* | CodeableConcept | The kind of relationship Binding: PatientContactRelationship (extensible) | |
| name | 0..1 | HumanName | A name associated with the contact person | |
| telecom | 0..* | ContactPoint | A contact detail for the person | |
| address | 0..1 | Address | Address for the contact person | |
| gender | 0..1 | code | male | female | other | unknown Binding: AdministrativeGender (required) | |
| organization | I | 0..1 | Reference(Organization) | Organization that is associated with the contact |
| period | 0..1 | Period | The period during which this contact person or organization is valid to be contacted relating to this patient | |
| communication | I | 0..* | BackboneElement | A language which may be used to communicate with the patient about his or her health |
| 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 |
| language | 1..1 | CodeableConcept | The language which can be used to communicate with the patient about his or her health Binding: CommonLanguages (preferred) Max Binding: AllLanguages | |
| preferred | 0..1 | boolean | Language preference indicator | |
| generalPractitioner | 0..* | Reference(Organization | Practitioner | PractitionerRole) | Patient's nominated primary care provider | |
| managingOrganization | Σ | 0..1 | Reference(Organization) | Organization that is the custodian of the patient record |
| link | ?!ΣI | 0..* | BackboneElement | Link to another patient resource that concerns the same actual person |
 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 |
| other | Σ | 1..1 | Reference(Patient | RelatedPerson) | The other patient or related person resource that the link refers to |
| type | Σ | 1..1 | code | replaced-by | replaces | refer | seealso Binding: LinkType (required) |
| Documentation for this format | ||||
This structure is derived from Patient
Differential View
This structure is derived from Patient
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Patient | I | 0..* | Information about an individual or animal receiving health care services | |
| 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) Max Binding: AllLanguages | |
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |
| contained | 0..* | Resource | Contained, inline Resources | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
| identifier | SΣ | 1..* | Identifier | An identifier for this patient |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required) |
| type | Σ | 0..1 | CodeableConcept | Description of identifier Binding: Identifier Type Codes (extensible) |
| system | SΣ | 0..1 | uri | The namespace for the identifier value Example General': http://www.acme.com/identifiers/patient |
| value | Σ | 0..1 | string | The value that is unique Example General': 123456 |
| period | Σ | 0..1 | Period | Time period when id is/was valid for use |
| assigner | Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) |
| active | ?!Σ | 0..1 | boolean | Whether this patient's record is in active use |
| gender | Σ | 0..1 | code | male | female | other | unknown Binding: AdministrativeGender (required) |
| birthDate | Σ | 0..1 | date | The date of birth for the individual |
| deceased[x] | ?!Σ | 0..1 | boolean, dateTime | Indicates if the individual is deceased or not |
| maritalStatus | 0..1 | CodeableConcept | Marital (civil) status of a patient Binding: Marital Status Codes (extensible) | |
| multipleBirth[x] | 0..1 | boolean, integer | Whether patient is part of a multiple birth | |
| contact | I | 0..* | BackboneElement | A contact party (e.g. guardian, partner, friend) for the patient pat-1: SHALL at least contain a contact's details or a reference to an organization |
| 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 |
| relationship | 0..* | CodeableConcept | The kind of relationship Binding: PatientContactRelationship (extensible) | |
| name | 0..1 | HumanName | A name associated with the contact person | |
| telecom | 0..* | ContactPoint | A contact detail for the person | |
| address | 0..1 | Address | Address for the contact person | |
| gender | 0..1 | code | male | female | other | unknown Binding: AdministrativeGender (required) | |
| organization | I | 0..1 | Reference(Organization) | Organization that is associated with the contact |
| period | 0..1 | Period | The period during which this contact person or organization is valid to be contacted relating to this patient | |
| communication | I | 0..* | BackboneElement | A language which may be used to communicate with the patient about his or her health |
| 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 |
| language | 1..1 | CodeableConcept | The language which can be used to communicate with the patient about his or her health Binding: CommonLanguages (preferred) Max Binding: AllLanguages | |
| preferred | 0..1 | boolean | Language preference indicator | |
| generalPractitioner | 0..* | Reference(Organization | Practitioner | PractitionerRole) | Patient's nominated primary care provider | |
| managingOrganization | Σ | 0..1 | Reference(Organization) | Organization that is the custodian of the patient record |
| link | ?!ΣI | 0..* | BackboneElement | Link to another patient resource that concerns the same actual person |
| 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 |
| other | Σ | 1..1 | Reference(Patient | RelatedPerson) | The other patient or related person resource that the link refers to |
| type | Σ | 1..1 | code | replaced-by | replaces | refer | seealso Binding: LinkType (required) |
| Documentation for this format | ||||
Other representations of profile: Schematron
| Path | Conformance | ValueSet |
| Patient.language | preferred | CommonLanguages Max Binding: AllLanguages |
| Patient.identifier.use | required | IdentifierUse |
| Patient.identifier.type | extensible | Identifier Type Codes |
| Patient.gender | required | AdministrativeGender |
| Patient.maritalStatus | extensible | Marital Status Codes |
| Patient.contact.relationship | extensible | PatientContactRelationship |
| Patient.contact.gender | required | AdministrativeGender |
| Patient.communication.language | preferred | CommonLanguages Max Binding: AllLanguages |
| Patient.link.type | required | LinkType |
| Id | Path | Details | Requirements |
| dom-2 | Patient | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-4 | Patient | 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-3 | Patient | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-6 | Patient | A resource should have narrative for robust management : text.div.exists() | |
| dom-5 | Patient | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| ele-1 | Patient.contact | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| pat-1 | Patient.contact | SHALL at least contain a contact's details or a reference to an organization : name.exists() or telecom.exists() or address.exists() or organization.exists() | |
| ele-1 | Patient.communication | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | Patient.link | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
CR Core Implementation Guide © 2018+ Clinical Research Core Implementation Guide. Based on FHIR version (4.0.0). IG generated on Thu, Jun 20, 2019 11:42-0400.
Links: Table of Contents |
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