: Public Class
Created: 7/25/2007 10:12:53 AM
Modified: 8/26/2017 2:00:41 AM
Project:
Advanced:
DEFINITION:<br/>An organization that approves, monitors and reviews biomedical research to protect the rights, safety and welfare of the study subjects. This committee performs critical oversight functions for research conducted on human study subjects that are scientific, ethical, and regulatory.<br/><br/>EXAMPLE(S):<br/>Institutional Review Board (IRB), ethics committee, research ethics board<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Attribute
Public CD
  typeCode
Details:
Map:CTOM=Data Monitoring Committee
Map:CTRPv1.0=OversightCommittee.typeCode
Map:CTRPv3.8=OversightCommittee.typeCode
Map:CTRR=IRB Affiliation
Map:CTRR=Oversight Authority
Map:CTRR=IRB Organization
Map:CTRRr3=OversightCommittee.typeCode
Map:CTRv1.0=OversightCommittee.typeCode
Map:HSDBv1.0=[IRB].IRB type
Map:SDTM IGv3.1.3=TU.TUEVAL
Map:SDTM IGv3.1.3=EG.EGEVAL
Map:SDTM IGv3.1.3=FA.FAEVAL
Map:SDTM IGv3.1.3=RS.RSEVAL
Map:SDTM IGv3.1.3=TR.TREVAL
Notes: DEFINITION:<br/>A coded value specifying the kind of oversight committee.<br/><br/>EXAMPLE(S):<br/>Adjudication Committee, IRB, Data Safety Monitoring Board<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public IVL<TS.DATETIME>
  effectiveDateRange
Details:
Map:CTRPv1.0=OversightCommittee.statusDateRange
Map:CTRPv1.0=OversightCommittee.statusCode
Map:CTRv1.0=OversightCommittee.effectiveDateRange
Notes: DEFINITION:<br/>The date (and time) span for when the oversight committee is active.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Element Source Role Target Role
HealthcareFacility
Class  
Name: overseeingOversightCommittee
 
Name: overseenHealthcareFacility
 
Details:
DESCRIPTION:<br/>Each OversightCommittee might oversee one or more HealthcareFacility. Each HealthcareFacility might be overseen by one or more OversightCommittee.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
StudySite
Class  
Name: overseeingOversightCommittee
 
Name: overseenStudySite
 
Details:
DESCRIPTION:<br/>Each OversightCommittee might oversee one or more StudySite. Each StudySite might be overseen by one or more OversightCommittee.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Element Source Role Target Role
Performer
Class  
Name: performedPerformer
 
Name: performingOversightCommittee
 
Details:
DESCRIPTION:<br/>Each Performer might be a function performed by one OversightCommittee.  Each OversightCommittee might function as one or more Performer.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
DataMonitoringCommitteeCharterVersion
Class  
Name: governingDataMonitoringCommitteeCharterVersion
 
Name: governedOversightCommittee
 
Details:
DESCRIPTION:<br/>Each DataMonitoringCommitteeCharterVersion always governs one OversightCommittee. Each OversightCommittee might be governed by one or more DataMonitoringCommitteeCharterVersion.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
StudySiteOversightStatus
Class  
Name: assignedStudySiteOversightStatus
 
Name: assigningOversightCommittee
 
Details:
DESCRIPTION:<br/>Each StudySiteOversightStatus might be assigned by one OversightCommittee.  Each OversightCommittee might assign one or more StudySiteOversightStatus.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Tag Value
Map:CTOM HealthcareSiteParticipantRole.roleCode
Details:
 
Map:CTRPv1.0 OversightCommittee
Details:
 
Map:CTRPv3.8 OversightCommittee
Details:
 
Map:CTRRr3 OversightCommittee
Details:
 
Map:CTRv1.0 OversightCommittee
Details:
 
Map:HL7SP Verifier
Details:
 
Map:HL7SP EthicalCommittee
Details:
 
Map:HL7SP ServiceProvider
Details:
 
Map:HSDBv1.0 [Lead Organization] .Organization Type
Details:
 
Object Type Connection Direction Notes
OversightAuthority Class Generalization To DESCRIPTION: Each OversightCommittee always specializes one OversightAuthority. Each OversightAuthority might be specialized by one OversightCommittee. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):