ORSCF-StudyManagement Schema Specification

Info
author: ORSCF ("Open Research Study Communication Formats") / T.Korn
license: Apache-2
version: 1.6.0
timestamp: 2021-11-07 00:00

Contents

Model:

chart

Institute

Fields

Name Type Required Fix
InstituteUid (PK) guid YES no
DisplayLabel string (100) YES no
IsArchived boolean YES no
OwnPatientSdrEndpointUid (FK) guid YES no

Unique Keys

  • InstituteUid (primary)

Institute.InstituteUid (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

Institute.DisplayLabel (Field)

An DisplayLabel which is dedicated for the usage within the frontend of study managent software. Note that this short name representation hat the caracter of an internal shortcurt and could be ambiguous. The usage for legal-relevant/official communication or documents is not recommended, as well as the usage for technical identification of this record.

  • the maximum length of the content within this field is 100 characters.

Institute.OwnPatientSdrEndpointUid (Field)

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

Relations

Navigation-Name Role Target-Type Target-Multiplicity
InitiatedStudies Referers ResearchStudy * (multiple)
RepresentedSites Referers Site * (multiple)
ProvidedSystemEndpoints Childs SystemEndpoint * (multiple)
SystemAssignment Childs InstituteRelatedSystemAssignemnt * (multiple)
OwnPatientSdr Lookup SystemEndpoint 0/1 (optional)
SystemConnections Childs SystemConnection * (multiple)
InitiatedStudies (refering to this Institute)

Target: ResearchStudy

RepresentedSites (refering to this Institute)

Target: Site

ProvidedSystemEndpoints (childs of this Institute)

Target: SystemEndpoint

SystemAssignment (childs of this Institute)

Target: InstituteRelatedSystemAssignemnt

OwnPatientSdr (lookup from this Institute)

Target Type: SystemEndpoint Addressed by: OwnPatientSdrEndpointUid.

SystemConnections (childs of this Institute)

Target: SystemConnection

InstituteRelatedSystemAssignemnt

Fields

Name Type Required Fix
InstituteRelatedSystemAssignemntUid (PK) guid YES no
SystemEndpointUid (FK) guid YES no
InstituteUid (FK) guid YES no
UseAsOwnPatientSdr string YES no
UseAsCandidateSdr string YES no
UseAsOwnWdr string YES no
UseAsConsumingExternalWdr string YES no

Unique Keys

  • InstituteRelatedSystemAssignemntUid (primary)

InstituteRelatedSystemAssignemnt.InstituteRelatedSystemAssignemntUid (Field)

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

InstituteRelatedSystemAssignemnt.SystemEndpointUid (Field)

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

InstituteRelatedSystemAssignemnt.InstituteUid (Field)

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

Relations

Navigation-Name Role Target-Type Target-Multiplicity
Institute Parent Institute 0/1 (optional)
SystemEndpoint Lookup SystemEndpoint 0/1 (optional)
Institute (parent of this InstituteRelatedSystemAssignemnt)

Target Type: Institute Addressed by: InstituteUid.

SystemEndpoint (lookup from this InstituteRelatedSystemAssignemnt)

Target Type: SystemEndpoint Addressed by: SystemEndpointUid.

SystemConnection

Fields

Name Type Required Fix
SystemConnectionUid (PK) guid YES no
OwnerInstituteUid (FK) guid YES no
HierSpšterJWTSEttings string YES no
TargetSystemEndpointUid (FK) guid YES no
DedicatedSiteRelatedSystemAssignmentUid (FK) guid no no

Unique Keys

  • SystemConnectionUid (primary)

SystemConnection.SystemConnectionUid (Field)

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

SystemConnection.OwnerInstituteUid (Field)

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

SystemConnection.TargetSystemEndpointUid (Field)

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

SystemConnection.DedicatedSiteRelatedSystemAssignmentUid (Field)

  • this field is optional, so that 'null' values are supported
  • this field is used as foreign key to address the related 'DedicatedSiteRelatedSystemAssignment'

Relations

Navigation-Name Role Target-Type Target-Multiplicity
OwnerInstitute Parent Institute 0/1 (optional)
DedicatedSiteRelatedSystemAssignment Lookup SiteRelatedSystemAssignment 1 (required)
TargetEndpoint Lookup SystemEndpoint 0/1 (optional)
OwnerInstitute (parent of this SystemConnection)

Target Type: Institute Addressed by: OwnerInstituteUid.

DedicatedSiteRelatedSystemAssignment (lookup from this SystemConnection)

Target Type: SiteRelatedSystemAssignment Addressed by: DedicatedSiteRelatedSystemAssignmentUid.

TargetEndpoint (lookup from this SystemConnection)

Target Type: SystemEndpoint Addressed by: TargetSystemEndpointUid.

SystemEndpoint

Fields

Name Type Required Fix
SystemEndpointUid (PK) guid YES no
ProviderInstituteUid (FK) guid YES no
AvailableRoles string YES no
Url string YES no
ApprovedCert string YES no
IsPublic string YES no
Label string YES no

Unique Keys

  • SystemEndpointUid (primary)

SystemEndpoint.SystemEndpointUid (Field)

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

SystemEndpoint.ProviderInstituteUid (Field)

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

Relations

Navigation-Name Role Target-Type Target-Multiplicity
ProviderInstitute Parent Institute 0/1 (optional)
InstituteAssignments Referers InstituteRelatedSystemAssignemnt * (multiple)
SiteAssignments Referers SiteRelatedSystemAssignment * (multiple)
StudyAssignments Referers StudyRelatedSystemAssignment * (multiple)
ProviderInstitute (parent of this SystemEndpoint)

Target Type: Institute Addressed by: ProviderInstituteUid.

InstituteAssignments (refering to this SystemEndpoint)

Target: InstituteRelatedSystemAssignemnt

SiteAssignments (refering to this SystemEndpoint)

Target: SiteRelatedSystemAssignment

StudyAssignments (refering to this SystemEndpoint)

Target: StudyRelatedSystemAssignment

InvolvedPerson

Fields

Name Type Required Fix
InvolvedPersonUid (PK) guid YES no
DisplayLabel string no no
EmailAddress guid no no
IsArchived boolean YES no

Unique Keys

  • InvolvedPersonUid (primary)

InvolvedPerson.InvolvedPersonUid (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

InvolvedPerson.DisplayLabel (Field)

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

InvolvedPerson.EmailAddress (Field)

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

Relations

Navigation-Name Role Target-Type Target-Multiplicity
InvolvementRoles Referers InvolvementRole * (multiple)
InvolvementRoles (refering to this InvolvedPerson)

Target: InvolvementRole

ResearchStudy

entity, which relates to HL7.ResearchStudy

Fields

Name Type Required Fix
ResearchStudyUid (PK) guid YES no
DisplayLabel string (100) YES no
InitiatorInstituteUid (FK) guid YES no
StudyWorkflowName string YES no
StudyWorkflowVersion string YES no
Phase string no no
StartDate datetime no no
TerminationDate datetime no no
SubjectIdentifierTitle string YES no
Status string YES no
TerminatedReason string no no
IsArchived boolean YES no
InitiatorRelatedProjectNumber string no no
OriginWdrEndpointUid (FK) guid YES no
PrimaryImsEndpointUid (FK) guid YES no

Unique Keys

  • ResearchStudyUid (primary)

ResearchStudy.ResearchStudyUid (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

ResearchStudy.DisplayLabel (Field)

An DisplayLabel which is dedicated for the usage within the frontend of study managent software. Note that this short name representation hat the caracter of an internal shortcurt and could be ambiguous. The usage for legal-relevant/official communication or documents is not recommended, as well as the usage for technical identification of this record.

  • the maximum length of the content within this field is 100 characters.

ResearchStudy.InitiatorInstituteUid (Field)

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

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.StartDate (Field)

a estimated date in future is possible

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

ResearchStudy.TerminationDate (Field)

a estimated date in future is possible

  • 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.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

ResearchStudy.InitiatorRelatedProjectNumber (Field)

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

ResearchStudy.OriginWdrEndpointUid (Field)

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

ResearchStudy.PrimaryImsEndpointUid (Field)

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

Relations

Navigation-Name Role Target-Type Target-Multiplicity
InitiatorInstitute Lookup Institute 0/1 (optional)
InvolvementRoles Childs InvolvementRole * (multiple)
Sites Childs Site * (multiple)
OriginWdr Lookup SystemEndpoint 0/1 (optional)
PrimaryIms Lookup SystemEndpoint 0/1 (optional)
SystemAssignments Childs StudyRelatedSystemAssignment * (multiple)
InitiatorInstitute (lookup from this ResearchStudy)

Target Type: Institute Addressed by: InitiatorInstituteUid.

InvolvementRoles (childs of this ResearchStudy)

Target: InvolvementRole

Sites (childs of this ResearchStudy)

Target: Site

OriginWdr (lookup from this ResearchStudy)

Target Type: SystemEndpoint Addressed by: OriginWdrEndpointUid.

PrimaryIms (lookup from this ResearchStudy)

Target Type: SystemEndpoint Addressed by: PrimaryImsEndpointUid.

SystemAssignments (childs of this ResearchStudy)

Target: StudyRelatedSystemAssignment

InvolvementRole

Fields

Name Type Required Fix
InvolvedPersonRoleUid (PK) guid YES no
ResearchStudyUid (FK) guid YES no
Role string no no
InvolvedFrom datetime no no
InvolvedUntil datetime no no
DedicatedToSiteUid (FK) guid no no
InvolvedPersonUid (FK) guid YES no

Unique Keys

  • InvolvedPersonRoleUid (primary)

InvolvementRole.InvolvedPersonRoleUid (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

InvolvementRole.ResearchStudyUid (Field)

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

InvolvementRole.Role (Field)

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

InvolvementRole.InvolvedFrom (Field)

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

InvolvementRole.InvolvedUntil (Field)

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

InvolvementRole.DedicatedToSiteUid (Field)

null indicated a site independent global role

  • this field is optional, so that 'null' values are supported
  • this field is used as foreign key to address the related 'DedicatedToSite'

InvolvementRole.InvolvedPersonUid (Field)

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

Relations

Navigation-Name Role Target-Type Target-Multiplicity
InvolvedPerson Lookup InvolvedPerson 0/1 (optional)
ResearchStudy Parent ResearchStudy 0/1 (optional)
DedicatedToSite Lookup Site 1 (required)
InvolvedPerson (lookup from this InvolvementRole)

Target Type: InvolvedPerson Addressed by: InvolvedPersonUid.

ResearchStudy (parent of this InvolvementRole)

Target Type: ResearchStudy Addressed by: ResearchStudyUid.

DedicatedToSite (lookup from this InvolvementRole)

Target Type: Site Addressed by: DedicatedToSiteUid.

Site

Fields

Name Type Required Fix
SiteUid (PK) guid YES no
RepresentingInstituteUid (FK) guid YES no
ResearchStudyUid (FK) guid YES no
EnrollmentDate datetime no no
TerminationDate datetime no no
TerminatedReason string no no
StudyRelatedSiteIdentifer string YES no
DisplayLabel string YES no
Status string YES no
SiteRelatedProjectNumber string no no

Unique Keys

  • SiteUid (primary)

Site.SiteUid (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

Site.RepresentingInstituteUid (Field)

Universally Unique Identifier of the institute, which is representing this site

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

Site.ResearchStudyUid (Field)

Universally Unique Identifier of the related record

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

Site.EnrollmentDate (Field)

a estimated date in future is possible

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

Site.TerminationDate (Field)

a estimated date in future is possible

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

Site.TerminatedReason (Field)

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

Site.StudyRelatedSiteIdentifer (Field)

Offical 'SiteIdentifier' which is unique within the scope of the related study

Site.DisplayLabel (Field)

An DisplayLabel which is dedicated for the usage within the frontend of study managent software. Note that this short name representation hat the caracter of an internal shortcurt and could be ambiguous. The usage for legal-relevant/official communication or documents is not recommended, as well as the usage for technical identification of this record.

Site.Status (Field)

AS DECLARED BY HL7

Site.SiteRelatedProjectNumber (Field)

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

Relations

Navigation-Name Role Target-Type Target-Multiplicity
RepresentingInstitute Lookup Institute 0/1 (optional)
SiteDedicatedInvolvementRoles Referers InvolvementRole * (multiple)
Study Parent ResearchStudy 0/1 (optional)
SystemAssignments Childs SiteRelatedSystemAssignment * (multiple)
RepresentingInstitute (lookup from this Site)

Target Type: Institute Addressed by: RepresentingInstituteUid.

SiteDedicatedInvolvementRoles (refering to this Site)

Target: InvolvementRole

Study (parent of this Site)

Target Type: ResearchStudy Addressed by: ResearchStudyUid.

SystemAssignments (childs of this Site)

Target: SiteRelatedSystemAssignment

SiteRelatedSystemAssignment

Fields

Name Type Required Fix
SiteRelatedSystemAssignmentUid (PK) guid YES no
SystemEndpointUid (FK) guid YES no
SiteUid (FK) guid YES no

Unique Keys

  • SiteRelatedSystemAssignmentUid (primary)

SiteRelatedSystemAssignment.SiteRelatedSystemAssignmentUid (Field)

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

SiteRelatedSystemAssignment.SystemEndpointUid (Field)

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

SiteRelatedSystemAssignment.SiteUid (Field)

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

Relations

Navigation-Name Role Target-Type Target-Multiplicity
Site Parent Site 0/1 (optional)
SystemEndpoint Lookup SystemEndpoint 0/1 (optional)
DedicatedSystemConnection Referers SystemConnection * (multiple)
Site (parent of this SiteRelatedSystemAssignment)

Target Type: Site Addressed by: SiteUid.

SystemEndpoint (lookup from this SiteRelatedSystemAssignment)

Target Type: SystemEndpoint Addressed by: SystemEndpointUid.

DedicatedSystemConnection (refering to this SiteRelatedSystemAssignment)

Target: SystemConnection

StudyRelatedSystemAssignment

Fields

Name Type Required Fix
StudyRelatedSystemAssignmentUid (PK) guid YES no
ResearchStudyUid (FK) guid YES no
SystemEndpointUid (FK) guid YES no

Unique Keys

  • StudyRelatedSystemAssignmentUid (primary)

StudyRelatedSystemAssignment.StudyRelatedSystemAssignmentUid (Field)

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

StudyRelatedSystemAssignment.ResearchStudyUid (Field)

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

StudyRelatedSystemAssignment.SystemEndpointUid (Field)

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

Relations

Navigation-Name Role Target-Type Target-Multiplicity
ResearchStudy Parent ResearchStudy 0/1 (optional)
SystemEndpoint Lookup SystemEndpoint 0/1 (optional)
ResearchStudy (parent of this StudyRelatedSystemAssignment)

Target Type: ResearchStudy Addressed by: ResearchStudyUid.

SystemEndpoint (lookup from this StudyRelatedSystemAssignment)

Target Type: SystemEndpoint Addressed by: SystemEndpointUid.