: Public Class
Created: 1/11/2006 9:35:21 AM
Modified: 3/13/2015 4:05:23 PM
Project:
Advanced:
DEFINITION:<br /></p><p>A collection of submissions that are grouped together for regulatory purposes, and are usually specific to a particular device, food or feed additive or biopharmaceutical substance.<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>The marketing application for a drug product can generate multiple regulatory decisions. The first decision may support the initial marketing approval of the product for a specific indication. Subsequent regulatory decisions may approve or deny additional indications for the drug product. The application thus contains multiple submissions, each with their own regulatory action. <br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p><p>Over time, an application will typically consist of multiple submissions and regulatory assessments.<br /></p>
Attribute
Public II
  identifier
Details:
Map:caAERSv2.2=InvestigationalNewDrug.indNumber
Map:CTGOV=IND/IDE Number
Map:CTGOV=IND/IDE Protocol?
Map:CTOM=StudyAgent.investigationalNewDrugIdentifier
Map:CTR&Rr2=PIP Decision number
Map:CTRPv1.0=ObservationalStudyProtocol.indIdeIndicator
Map:CTRPv1.0=StudyProtocol.indIdeIndicator
Map:CTRPv3.8=StudyIndIde.indIdeNumber
Map:CTRR=Regulatory Investigational Product Application Identifier
Map:CTRR=IND/IDE Protocol (IND/IDE number suffix)
Map:CTRRr3=RegulatoryApplication.identifier
Map:CTRv1.0=RegulatoryApplication.identifier
Map:HCTv1.0=MD Anderson Specific Content: Protocol .IND number
Map:HSDBv1.0=[IND/IDE] .Number
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A unique symbol that establishes identity of the regulatory application.#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;
Public CD
  typeCode
Details:
Map:CTRPv3.8=StudyIndIde.indIdeTypeCode
Map:CTRR=IND/IDE Indicator
Map:CTRRr3=RegulatoryApplication.typeCode
Map:CTRv1.0=RegulatoryApplication.typeCode
Map:HSDBv1.0=[IND/IDE].Type
Map:RPS1=Application.code
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the kind of regulatory application. #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;New Drug Application, 510k, Veterinary New Drug Submission#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;#lt;p#gt;Each product type will be supported by a different application type. #lt;br /#gt;#lt;/p#gt;
Element Source Role Target Role
Submission
Class   		Name: groupedSubmission
  		Name: groupingRegulatoryApplication
 
Details:
DESCRIPTION:<br /></p><p>Each Submission always is grouped by one RegulatoryApplication. Each RegulatoryApplication always groups one or more Submission. <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:caAERSv2.2 InvestigationalNewDrug
Details:
 
Map:CTRPv3.8 StudyIndIde
Details:
 
Map:CTRRr3 RegulatoryApplication
Details:
 
Map:CTRv1.0 RegulatoryApplication
Details:
 
Map:RPS1 Application
Details:
 
Object Type Connection Direction Notes
Submission Class Strong From DESCRIPTION: Each Submission always is grouped by one RegulatoryApplication. Each RegulatoryApplication always groups one or more Submission. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):