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Biomedical Research and Regulation Work Group | Maturity Level: 1 | 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 not be treated as valid) |
Summary | true |
To Do | Should this be a common code system for all events? |
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 |
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 |
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) |