: Public <<DEPRECATED>> Class
Created: 1/16/2007 3:16:21 PM
Modified: 8/26/2017 2:46:30 AM
Project:
Advanced:
DEFINITION:<br/>A discrete portion of a submission which is used to receive agreement. Once agreement is reached on all units within the submission the submission can then be approved.<br/><br/>EXAMPLE(S):<br/>In a Modular pre-marketing application (PMA) several modules will be sent to the Food and Drug Administration (FDA). Each module will be agreed upon independently of other modules. The FDA then approves the submission based on compilation of all of the modules. These modules are reviewable units.<br/><br/>A veterinary medicine New Animal Drug Application (NADA) (marketing application) is constructed from the Investigational New Animal Drug Application (INADA). In the INADA process the sponsor creates reviewable units. These reviewable units are then compiled to be used as documentation for the marketing application. <br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Attribute
Public CD
  typeCode
Details:
Map:CTRv1.0=ReviewableUnit.typeCode
Map:RPS1=ReviewableUnit.contents
Notes: DEFINITION:<br/>A coded value specifying the kind of reviewable unit.<br/><br/>EXAMPLE(S):<br/>toxicology, safety, manufacturing, administrative<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Element Source Role Target Role
«DEPRECATED» Submission
Class   		Name: groupedReviewableUnit
  		Name: groupingSubmission
 
Details:
DESCRIPTION:<br/>Each ReviewableUnit always is grouped into one Submission.  Each Submission might group one or more ReviewableUnit.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Element Source Role Target Role
«DEPRECATED» SubmissionUnit
Class   		Name: groupedSubmissionUnit
  		Name: groupingReviewableUnit
 
Details:
DESCRIPTION:<br/>Each SubmissionUnit might be grouped into one ReviewableUnit.  Each ReviewableUnit always groups one or more SubmissionUnit.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Tag Value
Map:CTRv1.0 ReviewableUnit
Details:
 
Map:RPS1 ReviewableUnit
Details:
 
Object Type Connection Direction Notes
«DEPRECATED» Submission Class Strong To DESCRIPTION: Each ReviewableUnit always is grouped into one Submission. Each Submission might group one or more ReviewableUnit. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
«DEPRECATED» SubmissionUnit Class Strong From DESCRIPTION: Each SubmissionUnit might be grouped into one ReviewableUnit. Each ReviewableUnit always groups one or more SubmissionUnit. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):