: Public <<DEPRECATED>> Class
Created: 1/11/2006 9:35:21 AM
Modified: 8/26/2017 2:46:28 AM
Project:
Advanced:
DEFINITION:<br/>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/><br/>EXAMPLE(S):<br/>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/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>Over time, an application will typically consist of multiple submissions and regulatory assessments.<br/>
Attribute
Public ID
  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:<br/>A unique symbol that establishes identity of the regulatory application.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
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:<br/>A coded value specifying the kind of regulatory application. <br/><br/>EXAMPLE(S):<br/>New Drug Application, 510k, Veterinary New Drug Submission<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>Each product type will be supported by a different application type. <br/>
Element Source Role Target Role
«DEPRECATED» Submission
Class   		Name: groupedSubmission
  		Name: groupingRegulatoryApplication
 
Details:
DESCRIPTION:<br/>Each Submission always is grouped by one RegulatoryApplication. Each RegulatoryApplication always groups 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 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
«DEPRECATED» 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):