Release 5 Preview #1
AdministrationThis page is part of the FHIR Specification (v4.2.0: R5 Preview #1). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions 
. Page versions: R5 R4B R4 R3
| Biomedical Research and Regulation Work Group | Maturity Level: 0 | Trial Use | Security Category: Patient | Compartments: Patient |
Detailed Descriptions for the elements in the ResearchSubject resource.
| ResearchSubject | |
| Element Id | ResearchSubject |
| Definition | A physical entity which is the primary unit of operational and/or administrative interest in a study. |
| Cardinality | 0..* |
| Type | DomainResource |
| Alternate Names | Study Subject |
| Comments | Need to make sure we encompass public health studies. |
| ResearchSubject.identifier | |
| Element Id | ResearchSubject.identifier |
| Definition | Identifiers assigned to this research subject for a study. |
| Note | This is a business identifier, not a resource identifier (see discussion) |
| Cardinality | 0..* |
| Type | Identifier |
| Summary | true |
| ResearchSubject.status | |
| Element Id | ResearchSubject.status |
| Definition | The current state of the subject. |
| Cardinality | 1..1 |
| Terminology Binding | ResearchSubjectStatus (Required) |
| Type | code |
| Is Modifier | true (Reason: This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should be treated as invalid) |
| Summary | true |
| To Do | Should this be a common code system for all events? |
| ResearchSubject.progress | |
| Element Id | ResearchSubject.progress |
| Definition | The current state (status) of the subject and resons for status change where appropriate. |
| Cardinality | 0..* |
| Comments | This is intended to deal with the confusion routinely created by haing two conflated concepts of being in a particular state and having achieved a particular milestone. In strict terms a milestone is a point of time event that results in a change from one state to another. The state before the milestone is achieved is often given the same name as the milestone, and sometimes the state may have the same description. For instance "Randomised" and "Visit 1" may be different milestones but the state remains at "on study" after each of them. It is likely that more than one "state" pattern will be recorded for a subject and a type has been introduced to allow this simultaneous recording. |
| ResearchSubject.progress.type | |
| Element Id | ResearchSubject.progress.type |
| Definition | Identifies the aspect of the subject's journey that the state refers to. |
| Cardinality | 0..1 |
| Terminology Binding | ResearchSubjectStateType (Example) |
| Type | CodeableConcept |
| ResearchSubject.progress.state | |
| Element Id | ResearchSubject.progress.state |
| Definition | The current state of the subject. |
| Cardinality | 0..1 |
| Terminology Binding | ResearchSubjectState (Example) |
| Type | CodeableConcept |
| ResearchSubject.progress.milestone | |
| Element Id | ResearchSubject.progress.milestone |
| Definition | The milestones the subject has passed through. |
| Cardinality | 0..1 |
| Terminology Binding | ResearchSubjectMilestone (Example) |
| Type | CodeableConcept |
| Comments | There can be multiple entries but it is also valid to just have the most recent. This should npt be rlied upon as the full path the subject has taken. |
| ResearchSubject.progress.reason | |
| Element Id | ResearchSubject.progress.reason |
| Definition | The reason for the state change. If coded it should follow the formal subject state model. |
| Cardinality | 0..1 |
| Terminology Binding | StateChangeReason (Example) |
| Type | CodeableConcept |
| ResearchSubject.progress.startDate | |
| Element Id | ResearchSubject.progress.startDate |
| Definition | The date when the change in status occurred. |
| Cardinality | 1..1 |
| Type | dateTime |
| Comments | This is NOT the date the change in state was recorded. |
| ResearchSubject.period | |
| Element Id | ResearchSubject.period |
| Definition | The dates the subject began and ended their participation in the study. |
| Cardinality | 0..1 |
| Type | Period |
| Alternate Names | timing |
| Summary | true |
| To Do | .effectiveTime. |
| ResearchSubject.study | |
| Element Id | ResearchSubject.study |
| Definition | Reference to the study the subject is participating in. |
| Cardinality | 1..1 |
| Type | Reference(ResearchStudy) |
| Summary | true |
| ResearchSubject.individual | |
| Element Id | ResearchSubject.individual |
| Definition | The record of the person or animal who is involved in the study. |
| Cardinality | 1..1 |
| Type | Reference(Patient) |
| Summary | true |
| ResearchSubject.assignedArm | |
| Element Id | ResearchSubject.assignedArm |
| Definition | The name of the arm in the study the subject is expected to follow as part of this study. |
| Cardinality | 0..1 |
| Type | string |
| Comments | Maybe this is really PlanDefinition. |
| To Do | This ought to have an identifer as well as a name OR - allocation is to a Group which is part of a planDefinition which represents an Arm. |
| ResearchSubject.actualArm | |
| Element Id | ResearchSubject.actualArm |
| Definition | The name of the arm in the study the subject actually followed as part of this study. |
| Cardinality | 0..1 |
| Type | string |
| To Do | This ought to have an identifer as well as a name OR - allocation is to a Group which is part of a planDefinition which represents an Arm. |
| ResearchSubject.consent | |
| Element Id | ResearchSubject.consent |
| Definition | A record of the patient's informed agreement to participate in the study. |
| Cardinality | 0..1 |
| Type | Reference(Consent) |
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