IMPORTANT: ORSCF V2 was not relased – THIS IS AN ALPHA STATE!
see also: Swagger/OpenAPI definition
ORSCF-SubjectData Schema Specification
| Info | |
|---|---|
| author: | ORSCF ("Open Research Study Communication Formats") / T.Korn |
| license: | Apache-2 |
| version: | 2.0.0 |
| timestamp: | 2024-08-04 00:00 |
Contents
Model:
Subject
entity, which relates to HL7.ResearchSubject
Fields
| Name | Type | Required | Fix |
|---|---|---|---|
| SubjectUid (PK) | guid | YES | no |
| ActualSiteUid | guid | YES | no |
| EnrollingSiteUid | guid | YES | YES |
| PeriodStart | datetime | no | no |
| PeriodEnd | datetime | no | no |
| StatusNote | string | no | no |
| SubjectIdentifier | string | no | no |
| Status | string | YES | no |
| StudyUid | guid | YES | no |
| ModificationTimestampUtc | int64 | YES | no |
| IsArchived | boolean | YES | no |
| AssignedArm | string | YES | no |
| ActualArm | string | YES | no |
| SubstudyNames | string | YES | no |
Unique Keys
- SubjectUid (primary)
Subject.SubjectUid (Field)
An Universally Unique Identifier which can be generated by any origin system and is used to address this ORSCF conform data record in decentralized environments. Note that this Identity must not be changed any more!
- this field represents the identity (PK) of the record
Subject.EnrollingSiteUid (Field)
- after the record has been created, the value of this field must not be changed any more!
Subject.PeriodStart (Field)
- this field is optional, so that 'null' values are supported
Subject.PeriodEnd (Field)
- this field is optional, so that 'null' values are supported
Subject.StatusNote (Field)
- this field is optional, so that 'null' values are supported
Subject.SubjectIdentifier (Field)
- this field is optional, so that 'null' values are supported
Subject.Status (Field)
AS DECLARED BY HL7.ResearchSubjectStatus: candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn
Relations
| Navigation-Name | Role | Target-Type | Target-Multiplicity |
|---|---|---|---|
| SiteAssignments | Referers | SubjectSiteAssignment | * (multiple) |
SiteAssignments (refering to this Subject)
Target: SubjectSiteAssignment
SubjectSiteAssignment
Fields
| Name | Type | Required | Fix |
|---|---|---|---|
| SubjectSiteAssignmentUid (PK) | guid | YES | no |
| ValidFrom | datetime | YES | no |
| SiteUid | guid | YES | no |
| SubjectUid (FK) | guid | YES | no |
| SiteDefinedPatientIdentifier | string | no | no |
| ByInvolvedPersonUid | guid | no | no |
Unique Keys
- SubjectSiteAssignmentUid (primary)
SubjectSiteAssignment.SubjectSiteAssignmentUid (Field)
An Universally Unique Identifier which can be generated by any origin system and is used to address this ORSCF conform data record in decentralized environments. Note that this Identity must not be changed any more!
- this field represents the identity (PK) of the record
SubjectSiteAssignment.SiteUid (Field)
Universally Unique Identifier of the target Site
SubjectSiteAssignment.SubjectUid (Field)
Universally Unique Identifier of the target Subject
- this field is used as foreign key to address the related 'Subject'
SubjectSiteAssignment.SiteDefinedPatientIdentifier (Field)
This can be the ID ('surrogate-key') of the Partient record within a site specific patient management system. This MUST NOT be any natural key or plain readable name which exposes the identity of the patient!
- this field is optional, so that 'null' values are supported
SubjectSiteAssignment.ByInvolvedPersonUid (Field)
- this field is optional, so that 'null' values are supported
Relations
| Navigation-Name | Role | Target-Type | Target-Multiplicity |
|---|---|---|---|
| Subject | Lookup | Subject | 0/1 (optional) |
Subject (lookup from this SubjectSiteAssignment)
Target Type: Subject Addressed by: SubjectUid.