FHIR Osiris Implementation Guide
2.1.0 - ci-build
FHIR Osiris Implementation Guide
2.1.0 - ci-build
FHIR Osiris Implementation Guide - Local Development build (v2.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
| Official URL: https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/StructureDefinition/clinical-trial-subject | Version: 2.1.0 | |||
| Draft as of 2024-03-21 | Computable Name: ClinicalTrialSubject | |||
Subject that belongs to a oncology-related Clinical Trial.
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from ResearchSubject
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  ResearchSubject | 0..* | ResearchSubject | Physical entity which is the primary unit of interest in the study | |
  study | 1..1 | Reference(Oncology Clinical Trial) | Study subject is part of | |
 individual | 1..1 | Reference(Oncology Patient) | Who is part of study | |
| Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| ResearchSubject | 0..* | ResearchSubject | Physical entity which is the primary unit of interest in the study | |
 implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
 modifierExtension | ?!N | 0..* | Extension | Extensions that cannot be ignored Slice: Unordered, Open by value:url |
| status | ?!Σ | 1..1 | code | candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn Binding: ResearchSubjectStatus (required): Indicates the progression of a study subject through a study. |
| study | ΣC | 1..1 | Reference(Oncology Clinical Trial) | Study subject is part of ref-1: SHALL have a contained resource if a local reference is provided |
| individual | ΣC | 1..1 | Reference(Oncology Patient) | Who is part of study ref-1: SHALL have a contained resource if a local reference is provided |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| ResearchSubject.status | required | ResearchSubjectStatushttp://hl7.org/fhir/ValueSet/research-subject-status|4.0.1from the FHIR Standard |
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| ResearchSubject | 0..* | ResearchSubject | Physical entity which is the primary unit of interest in the study | |||||
| 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): A human language.
| |||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained | 0..* | Resource | Contained, inline Resources | |||||
 extension | N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
| modifierExtension | ?!N | 0..* | Extension | Extensions that cannot be ignored Slice: Unordered, Open by value:url | ||||
| identifier | Σ | 0..* | Identifier | Business Identifier for research subject in a study | ||||
| status | ?!Σ | 1..1 | code | candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn Binding: ResearchSubjectStatus (required): Indicates the progression of a study subject through a study. | ||||
| period | ΣC | 0..1 | Period | Start and end of participation per-1: If present, start SHALL have a lower value than end | ||||
| study | ΣC | 1..1 | Reference(Oncology Clinical Trial) | Study subject is part of ref-1: SHALL have a contained resource if a local reference is provided | ||||
| individual | ΣC | 1..1 | Reference(Oncology Patient) | Who is part of study ref-1: SHALL have a contained resource if a local reference is provided | ||||
| assignedArm | 0..1 | string | What path should be followed | |||||
| actualArm | 0..1 | string | What path was followed | |||||
| consent | C | 0..1 | Reference(Consent) | Agreement to participate in study ref-1: SHALL have a contained resource if a local reference is provided | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet | URI | |||
| ResearchSubject.language | preferred | CommonLanguages
http://hl7.org/fhir/ValueSet/languagesfrom the FHIR Standard | ||||
| ResearchSubject.status | required | ResearchSubjectStatushttp://hl7.org/fhir/ValueSet/research-subject-status|4.0.1from the FHIR Standard |
This structure is derived from ResearchSubject
Differential View
This structure is derived from ResearchSubject
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| ResearchSubject | 0..* | ResearchSubject | Physical entity which is the primary unit of interest in the study | |
| study | 1..1 | Reference(Oncology Clinical Trial) | Study subject is part of | |
| individual | 1..1 | Reference(Oncology Patient) | Who is part of study | |
| Documentation for this format | ||||
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| ResearchSubject | 0..* | ResearchSubject | Physical entity which is the primary unit of interest in the study | |
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| modifierExtension | ?!N | 0..* | Extension | Extensions that cannot be ignored Slice: Unordered, Open by value:url |
| status | ?!Σ | 1..1 | code | candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn Binding: ResearchSubjectStatus (required): Indicates the progression of a study subject through a study. |
| study | ΣC | 1..1 | Reference(Oncology Clinical Trial) | Study subject is part of ref-1: SHALL have a contained resource if a local reference is provided |
| individual | ΣC | 1..1 | Reference(Oncology Patient) | Who is part of study ref-1: SHALL have a contained resource if a local reference is provided |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| ResearchSubject.status | required | ResearchSubjectStatushttp://hl7.org/fhir/ValueSet/research-subject-status|4.0.1from the FHIR Standard |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| ResearchSubject | 0..* | ResearchSubject | Physical entity which is the primary unit of interest in the study | |||||
| 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): A human language.
| |||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained | 0..* | Resource | Contained, inline Resources | |||||
| extension | N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
| modifierExtension | ?!N | 0..* | Extension | Extensions that cannot be ignored Slice: Unordered, Open by value:url | ||||
| identifier | Σ | 0..* | Identifier | Business Identifier for research subject in a study | ||||
| status | ?!Σ | 1..1 | code | candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn Binding: ResearchSubjectStatus (required): Indicates the progression of a study subject through a study. | ||||
| period | ΣC | 0..1 | Period | Start and end of participation per-1: If present, start SHALL have a lower value than end | ||||
| study | ΣC | 1..1 | Reference(Oncology Clinical Trial) | Study subject is part of ref-1: SHALL have a contained resource if a local reference is provided | ||||
| individual | ΣC | 1..1 | Reference(Oncology Patient) | Who is part of study ref-1: SHALL have a contained resource if a local reference is provided | ||||
| assignedArm | 0..1 | string | What path should be followed | |||||
| actualArm | 0..1 | string | What path was followed | |||||
| consent | C | 0..1 | Reference(Consent) | Agreement to participate in study ref-1: SHALL have a contained resource if a local reference is provided | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet | URI | |||
| ResearchSubject.language | preferred | CommonLanguages
http://hl7.org/fhir/ValueSet/languagesfrom the FHIR Standard | ||||
| ResearchSubject.status | required | ResearchSubjectStatushttp://hl7.org/fhir/ValueSet/research-subject-status|4.0.1from the FHIR Standard |
This structure is derived from ResearchSubject
Other representations of profile: CSV, Excel, Schematron
IG © 2020+ Arkhn. Package arkhn.fhir.uv.osiris#2.1.0 based on FHIR 4.0.1. Generated 2024-03-21
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