: Public Class
Created: 6/18/2008 8:20:13 AM
Modified: 6/24/2013 11:30:38 PM
Project:
Advanced:
DEFINITION:<br /></p><p>A sponsor that initiates the investigation and is legally responsible for the study.<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>Government Agency examples: National Cancer Institute (NCI), National Institutes of Health (NIH), National Cancer Research Institute (NCRI)<br /></p><p><br /></p><p>Private industry examples: pharmaceutical companies<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
Attribute
Public BL
  primaryIndicator
Details:
Map:CTRR=Sponsor
Map:CTRv1.0=StudyLegalSponsor.primaryIndicator
Map:WHO=Primary Sponsor
Map:WHO=Secondary Sponsor
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Specifies whether this is the main or principal study legal sponsor.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
Element Source Role Target Role
StudyProtocolVersion
Class  
Name: sponsoringStudyLegalSponsor
 
Name: sponsoredStudyProtocolVersion
 
Details:
DESCRIPTION:<br /></p><p>Each StudyLegalSponsor always is responsible for one StudyProtocolVersion.  Each StudyProtocolVersion might be the responsibility of one or more StudyLegalSponsor.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
Organization
Class  
Name: performedStudyLegalSponsor
 
Name: performingOrganization
 
Details:
DESCRIPTION:<br /></p><p>Each StudyLegalSponsor might be a function performed by one Organization.  Each Organization might function as one or more StudyLegalSponsor.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
HealthcareProvider
Class  
Name: performedStudyLegalSponsor
 
Name: performingHealthcareProvider
 
Details:
DESCRIPTION:<br /></p><p>Each StudyLegalSponsor might be a function performed by one HealthcareProvider.  Each HealthcareProvider might function as one or more StudyLegalSponsor.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
Element Source Role Target Role
PerformedProtocolDeviation
Class  
Name: authorizedPerformedProtocolDeviation
 
Name: authorizingStudyLegalSponsor
 
Details:
DESCRIPTION:<br /></p><p>Each PerformedProtocolDeviation might be authorized by one StudyLegalSponsor.  Each StudyLegalSponsor might authorize one or more PerformedProtocolDeviation.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
Tag Value
Map:C3PR StudySponsor
Details:
 
Map:CTRR Secondary Sponsor
Details:
 
Map:CTRv1.0 StudyLegalSponsor
Details:
 
Map:HSDBv1.0 [Lead Organization] .Organization Type
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.