: Public Class
Created: 6/18/2008 8:20:13 AM
Modified: 5/11/2019 12:20:42 AM
Project:
Advanced:
DEFINITION:<br/>A sponsor that initiates the investigation and is legally responsible for the study.<br/><br/>EXAMPLE(S):<br/>Government Agency examples: National Cancer Institute (NCI), National Institutes of Health (NIH), National Cancer Research Institute (NCRI)<br/><br/>Private industry examples: pharmaceutical companies<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Attribute
Public BL
  primaryIndicator
Details:
Map:CTRR=Sponsor
Map:CTRv1.0=StudyLegalSponsor.primaryIndicator
Map:WHO=Primary Sponsor
Map:WHO=Secondary Sponsor
Notes: DEFINITION:<br/>Specifies whether this is the main or principal study legal sponsor.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Element Source Role Target Role
HealthcareProvider
Class  
Name: performedStudyLegalSponsor
 
Name: performingHealthcareProvider
 
Details:
DESCRIPTION:<br/>Each StudyLegalSponsor might be a function performed by one HealthcareProvider.  Each HealthcareProvider might function as one or more StudyLegalSponsor.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
StudyProtocolVersion
Class  
Name: sponsoringStudyLegalSponsor
 
Name: sponsoredStudyProtocolVersion
 
Details:
DESCRIPTION:<br/>Each StudyLegalSponsor always is responsible for one StudyProtocolVersion.  Each StudyProtocolVersion might be the responsibility of one or more StudyLegalSponsor.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Organization
Class  
Name: performedStudyLegalSponsor
 
Name: performingOrganization
 
Details:
DESCRIPTION:<br/>Each StudyLegalSponsor might be a function performed by one Organization.  Each Organization might function as one or more StudyLegalSponsor.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Element Source Role Target Role
PerformedProtocolDeviation
Class  
Name: authorizedPerformedProtocolDeviation
 
Name: authorizingStudyLegalSponsor
 
Details:
DESCRIPTION:<br/>Each PerformedProtocolDeviation might be authorized by one StudyLegalSponsor.  Each StudyLegalSponsor might authorize one or more PerformedProtocolDeviation.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Tag Value
Map:C3PR StudySponsor
Details:
 
Map:CTRR Secondary Sponsor
Details:
 
Map:CTRv1.0 StudyLegalSponsor
Details:
 
Map:HSDBv1.0 [Lead Organization] .Organization Type
Details:
 
Map:NBIAv6.4 Clinical_Trial_Sponsor
Details:
 
Constraint Type Status
be a function performed by Exclusive Or Invariant Approved
Details:
A StudyLegalSponsor is a function performed by one and only one of the following: HealthcareProvider, Organization.<br/>