CodeX Implementation Guide: ICAREdata v0.1.2

CodeX Implementation Guide: ICAREdata v0.1.2 FHIR Profiles - Local Development build (v0.1.2). See the Directory of published versions

ResearchSubject

Definitions for obf-ResearchSubject.

1. Basic
Definition

Record of a subject's enrollment and participation in a research study.

Control0..*
Alternate NamesZ-resource, Extension-resource, Custom-resource
2. Basic.id
Definition

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

Control0..1
Typeid
Comments

The only time that a resource does not have an id is when it is being submitted to the server using a create operation. Bundles always have an id, though it is usually a generated UUID.

3. Basic.meta
Definition

The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content may not always be associated with version changes to the resource.

Control0..1
TypeMeta
4. Basic.meta.id
Definition

unique id for the element within a resource (for internal references).

Control0..1
Typeid
5. Basic.meta.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

SlicingThis element introduces a set of slices on Basic.meta.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
6. sourcesystem
SliceNamesourcesystem
Definition

FHIR: This provides a minimal amount of Provenance information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc. FHIM: Identifies the computer system that created the medical record. This optional field may also be used to indicate that the medical record was originally created by a different organization from the one that is currently storing or utilizing the record in that the assigning authority of the Id could be set to that originating organization. This property is optional, as some systems will assume that all records that it contains originated in that system, however it is anticipated that it will become increasingly commonplace for records from multiple systems and organizations will be comingled in order to provide a complete picture of the patient's health record.

Control0..1
TypeExtension(SourceSystem) (Extension Type: uri)
7. Basic.meta.versionId
Definition

The version specific identifier, as it appears in the version portion of the URL. This values changes when the resource is created, updated, or deleted.

Control0..1
Typeid
Comments

The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.

8. Basic.meta.lastUpdated
Definition

When the resource last changed - e.g. when the version changed.

Control0..1
Typeinstant
Comments

This value is always populated except when the resource is first being created. The server / resource manager sets this value; what a client provides is irrelevant.

9. Basic.meta.profile
Definition

A list of profiles StructureDefinitions that this resource claims to conform to. The URL is a reference to StructureDefinition.url.

Control0..*
Typeuri
Comments

It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.

10. Basic.meta.security
Definition

Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.

Control0..*
BindingSecurity Labels from the Healthcare Privacy and Security Classification System.
The codes SHALL be taken from All Security Labels; other codes may be used where these codes are not suitable
TypeCoding
Comments

The security labels can be updated without changing the stated version of the resource The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored.

11. Basic.meta.tag
Definition

Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource.

Control0..*
BindingCodes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones"
TypeCoding
Comments

The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored.

12. Basic.implicitRules
Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content.

Control0..1
Typeuri
Is Modifiertrue
Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element as much as possible.

13. Basic.language
Definition

The base language in which the resource is written.

Control0..1
BindingA human language.
The codes SHALL be taken from http://tools.ietf.org/html/bcp47
Typecode
Comments

Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

14. Basic.text
Definition

A human-readable narrative that contains a summary of the resource, and may be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

Control0..1 This element is affected by the following invariants: dom-1
TypeNarrative
Alternate Namesnarrative, html, xhtml, display
Comments

Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative.

15. Basic.contained
Definition

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

Control0..*
TypeResource
Alternate Namesinline resources, anonymous resources, contained resources
Comments

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again.

16. Basic.extension
Definition

May be used to represent additional information that is not part of the basic definition of the resource. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control4..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

SlicingThis element introduces a set of slices on Basic.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
17. status
SliceNamestatus
Definition

A state that relates to the workflow or interpretation of this resource. Certain status values can modify the meaning of the resource, for example, entered-in-error. When a boolean value is used, Status of true indicates the record is active, false means inactive.

Control1..1
TypeExtension(Status) (Extension Type: CodeableConcept)
18. Basic.extension-status.id
Definition

unique id for the element within a resource (for internal references).

Control0..1
Typeid
19. Basic.extension-status.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..0
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

20. Basic.extension-status.url
Definition

Source of the definition for the extension code - a logical name or a URL.

Control1..1
Typeuri
Comments

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition should be version specific. This will ideally be the URI for the Resource Profile defining the extension, with the code for the extension after a #.

Fixed Valuehttp://mcodeinitiative.org/codex/us/icare/StructureDefinition/obf-Status-extension
21. Basic.extension-status.valueCodeableConcept
Definition

Value of extension - may be a resource or one of a constrained set of the data types (see Extensibility in the spec for list).

Control1..1
BindingThe codes SHALL be taken from research-subject-status
TypeCodeableConcept
22. identifier
SliceNameidentifier
Definition

Business identifier or external id for this resource.

Control0..1
TypeExtension(Identifier) (Extension Type: Identifier)
23. participationperiod
SliceNameparticipationperiod
Definition

The point in time or span of time the participant is involved.

Control1..1
TypeExtension(ParticipationPeriod) (Extension Type: Period)
24. researchstudy
SliceNameresearchstudy
Definition

A clinical trial or similar research study. Reference: list of FDA data elements describing a research study: prsinfo.clinicaltrials.gov/definitions.html

Control1..1
TypeExtension(ResearchStudy) (Extension Type: Reference(Basic))
25. patient
SliceNamepatient
Definition

A person in the role of a patient. Sometimes, the patient is not the subject of information in a clinical statement where the Patient is the SubjectOfRecord.

Compatibility: Lies at the intersection of Argonaut and US Core Patient. MaritalStatus has a required binding in Argonaut, but an extensible binding in US-Core. To be feasible under both DSTU2 Argonaut and STU3 US-Core, the required binding strength is adopted.

Control1..1
TypeExtension(Patient) (Extension Type: Reference(http://fhir.org/guides/argonaut/StructureDefinition/argo-patient))
26. assignedarm
SliceNameassignedarm
Definition

The name of the arm in the study the subject is expected to follow as part of this study.

Control0..1
TypeExtension(AssignedArm) (Extension Type: string)
27. actualarm
SliceNameactualarm
Definition

The name of the arm in the study the subject actually followed as part of this study.

Control0..1
TypeExtension(ActualArm) (Extension Type: string)
28. terminationreason
SliceNameterminationreason
Definition

A code explaining unplanned or premature termination of a plan of treatment, course of medication, or research study.

Control0..1
TypeExtension(TerminationReason) (Extension Type: CodeableConcept)
29. Basic.extension-terminationreason.id
Definition

unique id for the element within a resource (for internal references).

Control0..1
Typeid
30. Basic.extension-terminationreason.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..0
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

31. Basic.extension-terminationreason.url
Definition

Source of the definition for the extension code - a logical name or a URL.

Control1..1
Typeuri
Comments

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition should be version specific. This will ideally be the URI for the Resource Profile defining the extension, with the code for the extension after a #.

Fixed Valuehttp://mcodeinitiative.org/codex/us/icare/StructureDefinition/obf-TerminationReason-extension
32. Basic.extension-terminationreason.valueCodeableConcept
Definition

Value of extension - may be a resource or one of a constrained set of the data types (see Extensibility in the spec for list).

Control1..1
BindingThe codes SHALL be taken from ResearchSubjectTerminationReasonVS
TypeCodeableConcept
33. Basic.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the resource, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Control0..*
TypeExtension
Is Modifiertrue
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

34. Basic.identifier
Definition

Identifier assigned to the resource for business purposes, outside the context of FHIR.

NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
35. Basic.code
Definition

Identifies the 'type' of resource - equivalent to the resource name for other resources.

Control1..1
BindingCodes for identifying types of resources not yet defined by FHIR
For example codes, see Basic Resource Types
TypeCodeableConcept
Is Modifiertrue
Requirements

Must be able to distinguish different types of "basic" resources.

Comments

Because resource references will only be able to indicate 'Basic', the type of reference will need to be specified in a Profile identified as part of the resource. Refer to the resource notes section for information on appropriate terminologies for this code.

Pattern Value<valueCodeableConcept xmlns="http://hl7.org/fhir">
  <coding>
    <system value="http://mcodeinitiative.org/codex/us/icare/CodeSystem/icare-basic-resource-type"/>
    <code value="obf-ResearchSubject"/>
    <userSelected value="false"/>
  </coding>
</valueCodeableConcept>
36. Basic.subject
Definition

Identifies the patient, practitioner, device or any other resource that is the "focus" of this resource.

Control0..1
TypeReference(Resource)
Requirements

Needed for partitioning the resource by Patient.

Comments

Optional as not all resources potential resources will have subjects. Resources associated with multiple subjects can handle this via extension.

37. Basic.author
Definition

Indicates who was responsible for creating the resource instance.

Control0..1
TypeReference(Practitioner | Patient | RelatedPerson)
Requirements

Needed for partitioning the resource.

38. Basic.created
Definition

Identifies when the resource was first created.

Control0..1
Typedate
Requirements

Allows ordering resource instances by time.