: Public <<DEPRECATED>> Class
Created: 3/7/2007 11:20:55 AM
Modified: 5/11/2019 12:20:43 AM
Project:
Advanced:
DEFINITION:<br/>An organization or person that assumes responsibility for producing and submitting documentation to a regulatory authority to seek approval for testing, marketing and the continuation of marketing of new drugs or devices.<br/><br/>EXAMPLE(S):<br/>pharmaceutical company<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Attribute
Public IVL<TS.DATETIME>
  effectiveDateRange
Details:
Map:CTRv1.0=RegulatoryApplicationSponsor.effectiveDateRange
Map:RPS2=(New content)
Notes: DEFINITION:<br/>The date and time span for when the regulatory application sponsor is active.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Element Source Role Target Role
HealthcareProvider
Class  
Name: performedRegulatoryApplicationSponsor
 
Name: performingHealthcareProvider
 
Details:
DESCRIPTION:<br/>Each RegulatoryApplicationSponsor might be a function performed by one HealthcareProvider. Each HealthcareProvider might function as one or more RegulatoryApplicationSponsor.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Organization
Class  
Name: performedRegulatoryApplicationSponsor
 
Name: performingOrganization
 
Details:
DESCRIPTION:<br/>Each RegulatoryApplicationSponsor might be a function performed by one Organization.  Each Organization might function as one or more RegulatoryApplicationSponsor.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Element Source Role Target Role
┬źDEPRECATED┬╗ Submission
Class  
Name: submittedSubmission
 
Name: submittingRegulatoryApplicationSponsor
 
Details:
DESCRIPTION:<br/>Each Submission always is submitted by one RegulatoryApplicationSponsor.  Each RegulatoryApplicationSponsor always submits one or more Submission.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Tag Value
Map:caAERSv2.2 INDHolder
Details:
 
Map:CTRPv1.0 RegulatoryApplicationSponsor
Details:
 
Map:CTRRr3 RegulatoryApplicationSponsor
Details:
 
Map:CTRv1.0 RegulatoryApplicationSponsor
Details:
 
Map:ICSRr2 holder (in R_Product)
Details:
 
Map:ICSRr2 role (in R_Product)
Details:
 
Constraint Type Status
be a function performed by Exclusive Or Invariant Approved
Details:
A RegulatoryApplicationSponsor might be a function performed by one and only one of the following: Organization, HealthcareProvider.<br/>
be a function performed by actualIndicator Qualifier Invariant Approved
Details:
Only Organization with actualIndicator = "true" is valid.<br/>