R6 Ballot (1st Draft)
AdministrationThis page is part of the FHIR Specification v6.0.0-ballot1: Release 6 Ballot (1st Draft) (see Ballot Notes). The current version is 5.0.0. For a full list of available versions, see the Directory of published versions 
| 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.progress | |
| Element Id | ResearchSubject.progress |
| Definition | The current state (status) of the subject and resons for status change where appropriate. |
| Short Display | Subject status |
| Cardinality | 0..* |
| Summary | false |
| 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. |
| Short Display | state | milestone |
| Cardinality | 0..1 |
| Terminology Binding | Research Subject State Type (Example) |
| Type | CodeableConcept |
| Summary | false |
| ResearchSubject.progress.subjectState | |
| Element Id | ResearchSubject.progress.subjectState |
| Definition | The current state of the subject. |
| Short Display | candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn |
| Cardinality | 0..1 |
| Terminology Binding | Research Subject State (Required) |
| Type | CodeableConcept |
| Summary | false |
| ResearchSubject.progress.milestone | |
| Element Id | ResearchSubject.progress.milestone |
| Definition | The milestones the subject has passed through. |
| Short Display | SignedUp | Screened | Randomized |
| Cardinality | 0..1 |
| Terminology Binding | Research Subject Milestone (Example) |
| Type | CodeableConcept |
| Summary | false |
| 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. |
| Short Display | State change reason |
| Cardinality | 0..1 |
| Terminology Binding | StateChangeReason (Example) |
| Type | CodeableConcept |
| Summary | false |
| ResearchSubject.progress.startDate | |
| Element Id | ResearchSubject.progress.startDate |
| Definition | The date when the new status started. |
| Short Display | State change date |
| Cardinality | 0..1 |
| Type | dateTime |
| Requirements | This was originally defined as the date when the change in status occurred. This assumed all states were recorded which is not true. Hence the need to track the end of the state. |
| Summary | false |
| Comments | This is NOT the date the change in state was recorded. |
| ResearchSubject.progress.endDate | |
| Element Id | ResearchSubject.progress.endDate |
| Definition | The date when the state ended. |
| Short Display | State change date |
| Cardinality | 0..1 |
| Type | dateTime |
| Requirements | See the requirement on the start date. |
| Summary | false |
| 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.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-ballot1 generated on Mon, Dec 18, 2023 15:18+1100.
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