R6 Ballot (2nd Draft)
AdministrationPublish-box (todo)
Biomedical Research and Regulation  Work Group | Maturity Level: 0 | Trial Use | Security Category: Patient | Compartments: Device, Patient |
Detailed Descriptions for the elements in the ResearchSubject resource.
| ResearchSubject | |
| Element Id | ResearchSubject |
| Definition | A ResearchSubject is a participant or object which is the recipient of investigative activities in a research study. |
| Short Display | Participant or object which is the recipient of investigative activities in a study |
| Cardinality | 0..* |
| Type | DomainResource |
| Alternate Names | Study Subject |
| Summary | false |
| 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. |
| Short Display | Business Identifier for research subject in 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 publication state of the resource (not of the subject). |
| Short Display | draft | active | retired | unknown |
| Cardinality | 1..1 |
| Terminology Binding | PublicationStatus (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 |
| ResearchSubject.period | |
| Element Id | ResearchSubject.period |
| Definition | The dates the subject began and ended their participation in the study. |
| Short Display | Start and end of participation |
| 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. |
| Short Display | Study subject is part of |
| Cardinality | 1..1 |
| Type | Reference(ResearchStudy) |
| Summary | true |
| ResearchSubject.subject | |
| Element Id | ResearchSubject.subject |
| Definition | The record of the person, animal or other entity involved in the study. |
| Short Display | Who or what is part of study |
| Cardinality | 1..1 |
| Type | Reference(Patient | Group | Specimen | Device | Medication | Substance | BiologicallyDerivedProduct) |
| Summary | true |
| ResearchSubject.subjectState | |
| Element Id | ResearchSubject.subjectState |
| Definition | A duration in the lifecycle of the ResearchSubject within a ResearchStudy. |
| Short Display | A duration in the lifecycle of the ResearchSubject within a ResearchStudy |
| Cardinality | 0..* |
| Summary | false |
| ResearchSubject.subjectState.code | |
| Element Id | ResearchSubject.subjectState.code |
| Definition | Identifies the aspect of the subject's journey that the state refers to. |
| Short Display | candidate | in-prescreening | in-screening | eligible | ineligible | on-study | on-study-intervention | in-follow-up | off-study |
| Cardinality | 1..1 |
| Terminology Binding | Research Subject State (Extensible) |
| Type | CodeableConcept |
| Summary | false |
| ResearchSubject.subjectState.startDate | |
| Element Id | ResearchSubject.subjectState.startDate |
| Definition | The date a research subject entered the given state. |
| Short Display | The date a research subject entered the given state |
| Cardinality | 1..1 |
| Type | dateTime |
| Summary | false |
| ResearchSubject.subjectState.endDate | |
| Element Id | ResearchSubject.subjectState.endDate |
| Definition | The date a research subject exited or left the given state. |
| Short Display | The date a research subject exited or left the given state |
| Cardinality | 0..1 |
| Type | dateTime |
| Summary | false |
| ResearchSubject.subjectState.reason | |
| Element Id | ResearchSubject.subjectState.reason |
| Definition | The reason for the state change. If coded it should follow the formal subject state model. |
| Short Display | State change reason |
| Cardinality | 0..1 |
| Terminology Binding | StateChangeReason (Example) |
| Type | CodeableConcept |
| Summary | false |
| Comments | Example, if the milestone is "Randomized" then the reason could be "sponsor IVRS randomization code allocated". |
| ResearchSubject.subjectMilestone | |
| Element Id | ResearchSubject.subjectMilestone |
| Definition | A significant event in the progress of a ResearchSubject. |
| Short Display | A significant event in the progress of a ResearchSubject |
| Cardinality | 0..* |
| Summary | false |
| ResearchSubject.subjectMilestone.milestone | |
| Element Id | ResearchSubject.subjectMilestone.milestone |
| Definition | A specific event in the research subjects journey through a research study. |
| Short Display | SignedUp | Screened | Randomized |
| Cardinality | 1..* |
| Terminology Binding | Research Subject Milestone (Extensible) |
| Type | CodeableConcept |
| Summary | false |
| ResearchSubject.subjectMilestone.date | |
| Element Id | ResearchSubject.subjectMilestone.date |
| Definition | The date/time when this milestone event was completed. |
| Short Display | The date/time when this milestone event was completed |
| Cardinality | 0..1 |
| Type | dateTime |
| Summary | false |
| ResearchSubject.subjectMilestone.reason | |
| Element Id | ResearchSubject.subjectMilestone.reason |
| Definition | A rationale that provides additional clarification for the milestone that was captured or documented. |
| Cardinality | 0..1 |
| Type | CodeableConcept |
| Summary | false |
| ResearchSubject.assignedComparisonGroup | |
| Element Id | ResearchSubject.assignedComparisonGroup |
| Definition | The name of the arm in the study the subject is expected to follow as part of this study. |
| Short Display | What path should be followed |
| Cardinality | 0..1 |
| Type | id |
| Summary | false |
| Comments | Maybe this is really PlanDefinition. |
| To Do | This ought to have an identifier as well as a name OR - allocation is to a Group which is part of a planDefinition which represents an Arm. |
| ResearchSubject.actualComparisonGroup | |
| Element Id | ResearchSubject.actualComparisonGroup |
| Definition | The name of the arm in the study the subject actually followed as part of this study. |
| Short Display | What path was followed |
| Cardinality | 0..1 |
| Type | id |
| Summary | false |
| To Do | This ought to have an identifier 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. |
| Short Display | Agreement to participate in study |
| Cardinality | 0..* |
| Type | Reference(Consent) |
| Summary | false |
FHIR ®© HL7.org 2011+. FHIR R6 hl7.fhir.core#6.0.0-ballot2 generated on Mon, Aug 12, 2024 16:59+0800.
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