IMPORTANT: ORSCF V2 was not jet relased – THIS IS AN ALPHA STATE!

V1 can be found here

see also: Swagger/OpenAPI definition

ORSCF-StudyManagement Schema Specification

Info
author: ORSCF ("Open Research Study Communication Formats") / T.Korn
license: Apache-2
version: 2.0.0
timestamp: 2024-11-03 00:00

Contents

Model:

chart

DataEndpoint

Fields

Name Type Required Fix
Url (PK) string YES no
Label string YES no
OwnerInstituteUid (FK) guid YES no
PublicResolvable boolean YES no
EndpointType string YES no
OAuthUrl string YES no

Unique Keys

  • Url (primary)

DataEndpoint.Url (Field)

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

DataEndpoint.OwnerInstituteUid (Field)

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

DataEndpoint.EndpointType (Field)

SDR | WDR | IMS | VDR | BDR |

Relations

Navigation-Name Role Target-Type Target-Multiplicity
OwnerInstitute Lookup Institute 0/1 (optional)
OwnerInstitute (lookup from this DataEndpoint)

Target Type: Institute Addressed by: OwnerInstituteUid.

InstitueRelatedOAuthConfig

Fields

Name Type Required Fix
InstituteUid (PK) (FK) guid YES no
DataEndpointUrl (PK) (FK) string YES no
OAuthClientId string YES no
OAuthClientSecret string YES no
OAuthScopesRequired string YES no

Unique Keys

  • InstituteUid + DataEndpointUrl (primary)

InstitueRelatedOAuthConfig.InstituteUid (Field)

  • this field represents the identity (PK) of the record
  • this field is used as foreign key to address the related 'ForInstitute'

InstitueRelatedOAuthConfig.DataEndpointUrl (Field)

  • this field represents the identity (PK) of the record
  • this field is used as foreign key to address the related 'ForEndpoint'

Relations

Navigation-Name Role Target-Type Target-Multiplicity
ForInstitute Lookup Institute 0/1 (optional)
ForEndpoint Lookup DataEndpoint 0/1 (optional)
ForInstitute (lookup from this InstitueRelatedOAuthConfig)

Target Type: Institute Addressed by: InstituteUid.

ForEndpoint (lookup from this InstitueRelatedOAuthConfig)

Target Type: DataEndpoint Addressed by: DataEndpointUrl.

Institute

Fields

Name Type Required Fix
InstituteUid (PK) guid YES no
DisplayLabel string (100) YES no
IsArchived boolean YES no
PrivateSdrUrl string no no
PrivateWdrUrl string no no
PrivateVdrUrl string no no
PrivateBdrUrl string no 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.PrivateSdrUrl (Field)

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

Institute.PrivateWdrUrl (Field)

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

Institute.PrivateVdrUrl (Field)

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

Institute.PrivateBdrUrl (Field)

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

Relations

Navigation-Name Role Target-Type Target-Multiplicity
OwnedDataEndpoints Referers DataEndpoint * (multiple)
OAuthConfigs Referers InstitueRelatedOAuthConfig * (multiple)
InitiatedStudies Referers ResearchStudy * (multiple)
RepresentedSites Referers Site * (multiple)
OwnedDataEndpoints (refering to this Institute)

Target: DataEndpoint

OAuthConfigs (refering to this Institute)

Target: InstitueRelatedOAuthConfig

InitiatedStudies (refering to this Institute)

Target: ResearchStudy

RepresentedSites (refering to this Institute)

Target: Site

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
SdrUrl string no no
ImsUrl string no no
WdrUrl string no no
VdrUrl string no no
BdrUrl string no 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.SdrUrl (Field)

usually provided by the Sponsor

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

ResearchStudy.ImsUrl (Field)

usually provided by the Sponsor

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

ResearchStudy.WdrUrl (Field)

usually provided by the Sponsor

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

ResearchStudy.VdrUrl (Field)

usually provided by the Sponsor

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

ResearchStudy.BdrUrl (Field)

usually provided by the Sponsor

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

Relations

Navigation-Name Role Target-Type Target-Multiplicity
InitiatorInstitute Lookup Institute 0/1 (optional)
InvolvementRoles Childs InvolvementRole * (multiple)
Sites Childs Site * (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

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
DedicatedSdrUrl string no no
DedicatedVdrUrl string no no
DedicatedBdrUrl 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

Site.DedicatedSdrUrl (Field)

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

Site.DedicatedVdrUrl (Field)

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

Site.DedicatedBdrUrl (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)
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.