: Public <<DEPRECATED>> Class
Created: 1/11/2006 9:35:34 AM
Modified: 8/26/2017 2:46:30 AM
Project:
Advanced:
DEFINITION:<br/>The collection of documents provided to the regulatory authority at one time.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>A submission unit is made up of one to many document versions. Properly defined, the submission unit concept enables companies to create new submission units from any combination of new and previously submitted document versions.<br/><br/>In the dynamic aspects of the model, a submission unit is one message that may have a collection of many document versions. There are rules for how submission units are evaluated are described in a state diagram, and the receipt date of the submission unit "starts the clock" for the review of the contents of the submission unit.<br/>
Attribute
Public CD
  typeCode
Details:
Map:CTRv1.0=SubmissionUnit.typeCode
Map:RPS1=SubmissionUnit.type
Notes: DEFINITION:<br/>A coded value specifying the kind of submission unit.<br/><br/>EXAMPLE(S):<br/>original, amendment, supplement<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>Typically each submission unit type would cause a different regulatory request.<br/>
Public TS.DATETIME
  receiptDate
Details:
Map:CTRv1.0=SubmissionUnit.receiptDate
Map:RPS1=SubmissionUnit.receiptDate
Notes: DEFINITION:<br/>The date (and time) on which the submission unit is received by the regulatory authority. <br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S): <br/>Typically, this date will start a review clock, if applicable. The combination of the typeCode and where the SubmissionUnit was received will determine the deadline for the SubmissionUnit to be reviewed.<br/>
Public IVL<TS.DATETIME>
  effectiveDateRange
Details:
Map:CTRv1.0=SubmissionUnit.effectiveDateRange
Map:RPS1=ReviewableUnit.status
Map:RPS1=SubmissionUnit.status
Notes: DEFINITION:<br/>The date and time span for when the submission unit is active.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Element Source Role Target Role
«DEPRECATED» Submission
Class   		Name: groupedSubmissionUnit
  		Name: groupingSubmission
 
Details:
DESCRIPTION:<br/>Each SubmissionUnit might be grouped into one Submission.  Each Submission might group one or more SubmissionUnit.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
DocumentVersion
Class   		Name: includingSubmissionUnit
  		Name: includedDocumentVersion
 
Details:
DESCRIPTION:<br/>Each SubmissionUnit always includes one or more DocumentVersion.  Each DocumentVersion might be included in one or more SubmissionUnit.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
«DEPRECATED» ReviewableUnit
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:CTRRr3 SubmissionUnit
Details:
 
Map:CTRv1.0 SubmissionUnit
Details:
 
Map:RPS1 SubmissionUnit
Details:
 
Constraint Type Status
be grouped into Exclusive Or Invariant Approved
Details:
A SubmissionUnit might be grouped into one and only one of the following: Submission, ReviewableUnit.<br/>
Object Type Connection Direction Notes
«DEPRECATED» Submission Class Strong To DESCRIPTION: Each SubmissionUnit might be grouped into one Submission. Each Submission might group one or more SubmissionUnit. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
«DEPRECATED» ReviewableUnit Class Strong To 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):