ORSCF-StudyManagement Schema Specification

Info
author: ORSCF ("Open Research Study Communication Formats") / T.Korn
license: Apache-2
version: 1.5.0
timestamp: 2021-09-11 12:40

Contents

Model:

chart

Institute

Fields

Name Type Required Fix
InstituteUid (PK) guid YES no
InstituteTitle string YES no
IsArchived boolean YES no

Unique Keys

  • InstituteUid (primary)

Institute.InstituteUid (Field)

  • this field represents the identity (PK) of the record

Relations

Navigation-Name Role Target-Type Target-Multiplicity
SponsoredStudies Referers ResearchStudy * (multiple)
RepresentedSites Referers Site * (multiple)
SponsoredStudies (refering to this Institute)

Target: ResearchStudy

RepresentedSites (refering to this Institute)

Target: Site

ResearchStudy

entity, which relates to HL7.ResearchStudy

Fields

Name Type Required Fix
StudyIdentifier (PK) string (250) YES no
StudyTitle string YES no
SponsoringInstituteUid (FK) guid YES no
StudyWorkflowName string YES no
StudyWorkflowVersion string YES no
Phase string no no
LKP string no no
StartDate datetime no no
TerminationDate datetime no no
SubjectIdentifierTitle string YES no
ImsApiUrl string no no
VdrApiUrl string no no
BdrApiUrl string no no
WdrApiUrl string no no
Status string YES no
TerminatedReason string no no
IsArchived boolean YES no

Unique Keys

  • StudyIdentifier (primary)

ResearchStudy.StudyIdentifier (Field)

  • this field represents the identity (PK) of the record
  • the maximum length of the content within this field is 250 characters.

ResearchStudy.SponsoringInstituteUid (Field)

  • this field is used as foreign key to address the related 'SponsoringInstitute'

ResearchStudy.Phase (Field)

AS DECLARED BY HL7.ResearchStudyPhase: n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4

  • this field is optional, so that 'null' values are supported

ResearchStudy.LKP (Field)

  • this field is optional, so that 'null' values are supported

ResearchStudy.StartDate (Field)

  • this field is optional, so that 'null' values are supported

ResearchStudy.TerminationDate (Field)

  • this field is optional, so that 'null' values are supported

ResearchStudy.SubjectIdentifierTitle (Field)

A title which informs about the sematic of the SubjectIdentifer (which concrete value is used): "Randomization-Number", "Screening-Number", ...

ResearchStudy.ImsApiUrl (Field)

Url of the API Endpoint which provides access to the 'IdentityManagementSystem' for this study (following the ORSCF-Standard)

  • this field is optional, so that 'null' values are supported

ResearchStudy.VdrApiUrl (Field)

Url of the API Endpoint which provides access to the 'VisitDataRepository' for this study (following the ORSCF-Standard)

  • this field is optional, so that 'null' values are supported

ResearchStudy.BdrApiUrl (Field)

Url of the API Endpoint which provides access to the 'BillingDataRepository' for this study (following the ORSCF-Standard)

  • this field is optional, so that 'null' values are supported

ResearchStudy.WdrApiUrl (Field)

Url of the API Endpoint which provides access to the 'WorkflowDefinitionRepository' for this study (following the ORSCF-Standard)

  • this field is optional, so that 'null' values are supported

ResearchStudy.Status (Field)

AS DECLARED BY HL7.ResearchStudyStatus: active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn

ResearchStudy.TerminatedReason (Field)

  • this field is optional, so that 'null' values are supported

Relations

Navigation-Name Role Target-Type Target-Multiplicity
SponsoringInstitute Lookup Institute 0/1 (optional)
SiteParticipations Childs Site * (multiple)
Subjects Childs Subject * (multiple)
SponsoringInstitute (lookup from this ResearchStudy)

Target Type: Institute Addressed by: SponsoringInstituteUid.

SiteParticipations (childs of this ResearchStudy)

Target: Site

Subjects (childs of this ResearchStudy)

Target: Subject

Site

Fields

Name Type Required Fix
SiteIdentifier (PK) string (250) YES no
RepresentingInstituteUid (FK) guid YES no
StudyIdentifier (PK) (FK) string (250) YES no
EnrollmentDate datetime no no
TerminationDate datetime no no
TerminatedReason string no no
SiteTitle string YES no
Status string YES no

Unique Keys

  • SiteIdentifier + StudyIdentifier (primary)

Site.SiteIdentifier (Field)

  • this field represents the identity (PK) of the record
  • the maximum length of the content within this field is 250 characters.

Site.RepresentingInstituteUid (Field)

  • this field is used as foreign key to address the related 'RepresentingInstitute'

Site.StudyIdentifier (Field)

  • this field represents the identity (PK) of the record
  • this field is used as foreign key to address the related 'Study'
  • the maximum length of the content within this field is 250 characters.

Site.EnrollmentDate (Field)

  • this field is optional, so that 'null' values are supported

Site.TerminationDate (Field)

  • this field is optional, so that 'null' values are supported

Site.TerminatedReason (Field)

  • this field is optional, so that 'null' values are supported

Site.Status (Field)

AS DECLARED BY HL7

Relations

Navigation-Name Role Target-Type Target-Multiplicity
RepresentingInstitute Lookup Institute 0/1 (optional)
Study Parent ResearchStudy 0/1 (optional)
ActualSubjects Referers Subject * (multiple)
EnrolledSubjects Referers Subject * (multiple)
RepresentingInstitute (lookup from this Site)

Target Type: Institute Addressed by: RepresentingInstituteUid.

Study (parent of this Site)

Target Type: ResearchStudy Addressed by: StudyIdentifier.

ActualSubjects (refering to this Site)

Target: Subject

EnrolledSubjects (refering to this Site)

Target: Subject

Subject

entity, which relates to HL7.ResearchSubject

Fields

Name Type Required Fix
CandidateIdentifier (PK) string (250) YES no
ActualSiteIdentifier (FK) string (250) YES no
StudyIdentifier (PK) (FK) string (250) YES no
EnrollingSiteIdentifier (FK) string (250) YES no
EnrollmentDate datetime no no
TerminationDate datetime no no
TerminatedReason string no no
SubjectIdentifier string no no
Status string YES no
CustomDisplayTitle string no no
SiteSpecificPatientIdentifier string no no

Unique Keys

  • CandidateIdentifier + StudyIdentifier (primary)

Subject.CandidateIdentifier (Field)

  • this field represents the identity (PK) of the record
  • the maximum length of the content within this field is 250 characters.

Subject.ActualSiteIdentifier (Field)

  • this field is used as foreign key to address the related 'ActualSite'
  • the maximum length of the content within this field is 250 characters.

Subject.StudyIdentifier (Field)

  • this field represents the identity (PK) of the record
  • this field is used as foreign key to address the related 'Study'
  • this field is used as foreign key to address the related 'ActualSite'
  • this field is used as foreign key to address the related 'EnrollingSite'
  • the maximum length of the content within this field is 250 characters.

Subject.EnrollingSiteIdentifier (Field)

  • this field is used as foreign key to address the related 'EnrollingSite'
  • the maximum length of the content within this field is 250 characters.

Subject.EnrollmentDate (Field)

  • this field is optional, so that 'null' values are supported

Subject.TerminationDate (Field)

  • this field is optional, so that 'null' values are supported

Subject.TerminatedReason (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

Subject.CustomDisplayTitle (Field)

  • this field is optional, so that 'null' values are supported

Subject.SiteSpecificPatientIdentifier (Field)

  • this field is optional, so that 'null' values are supported

Relations

Navigation-Name Role Target-Type Target-Multiplicity
Study Parent ResearchStudy 0/1 (optional)
ActualSite Lookup Site 0/1 (optional)
EnrollingSite Lookup Site 0/1 (optional)
Study (parent of this Subject)

Target Type: ResearchStudy Addressed by: StudyIdentifier.

ActualSite (lookup from this Subject)

Target Type: Site Addressed by: ActualSiteIdentifier + StudyIdentifier.

EnrollingSite (lookup from this Subject)

Target Type: Site Addressed by: EnrollingSiteIdentifier + StudyIdentifier.