: Public Class
Created: 7/11/2008 10:13:25 AM
Modified: 8/26/2017 2:00:41 AM
Project:
Advanced:
DEFINITION:<br/>An organization with monitoring, regulatory, or supervisory authority over biomedical research at the local, regional, national, or international level.<br/><br/>EXAMPLE(S):<br/>Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK, Food and Drug Administration (FDA) in the USA, World Health Organization (WHO), Institutional Review Board (IRB), Ethics committee, Research ethics board<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Element Source Role Target Role
Organization
Class  
Name: performedOversightAuthority
 
Name: performingOrganization
 
Details:
DESCRIPTION:<br/>Each OversightAuthority always is a function performed by one Organization.  Each Organization might function as one OversightAuthority.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Element Source Role Target Role
StudyOversightAuthority
Class  
Name: performedStudyOversightAuthority
 
Name: performingOversightAuthority
 
Details:
DESCRIPTION:<br/>Each StudyOversightAuthority always is a function performed by one OversightAuthority.  Each OversightAuthority might function as one or more StudyOversightAuthority.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Tag Value
Map:CTRR Oversight Authority
Details:
 
Map:CTRRr3 OversightAuthority
Details:
 
Map:CTRv1.0 OversightAuthority
Details:
 
Object Type Connection Direction Notes
OversightCommittee Class Generalization From DESCRIPTION: Each OversightCommittee always specializes one OversightAuthority. Each OversightAuthority might be specialized by one OversightCommittee. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
┬źDEPRECATED┬╗ RegulatoryAuthority Class Generalization From DESCRIPTION: Each RegulatoryAuthority always specializes one OversightAuthority. Each OversightAuthority might be specialized by one RegulatoryAuthority. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):