SubmissionUnit

: Public Class

Created:	1/11/2006 9:35:34 AM
Modified:	2/23/2012 4:19:09 PM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{8C9916AD-5E84-4ffd-B13C-6BECFEF14D45}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View RG: Regulatory

DEFINITION: The collection of documents provided to the regulatory authority at one time. EXAMPLE(S): OTHER NAME(S): NOTE(S): 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. 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.

Attributes
Associations To
Tagged Values
Constraints
Other Links

Attribute

Public CD
typeCode

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:1. to 1
Transient:	False
Derived:	False
IsID:	False

Map:CTRv1.0=SubmissionUnit.typeCode
Map:RPS1=SubmissionUnit.type

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the kind of submission unit.#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;original, amendment, supplement#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;Typically each submission unit type would cause a different regulatory request.#lt;br /#gt;#lt;/p#gt;

Public TS.DATETIME
receiptDate

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:CTRv1.0=SubmissionUnit.receiptDate
Map:RPS1=SubmissionUnit.receiptDate

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The date (and time) on which the submission unit is received by the regulatory authority. #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;#lt;p#gt;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.#lt;br /#gt;#lt;/p#gt;

Public IVL<TS.DATETIME>
effectiveDateRange

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:CTRv1.0=SubmissionUnit.effectiveDateRange
Map:RPS1=ReviewableUnit.status
Map:RPS1=SubmissionUnit.status

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The date and time span for when the submission unit is active.#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;

Element	Source Role	Target Role
Submission Class	Name: groupedSubmissionUnit	Name: groupingSubmission
Details: DESCRIPTION:<br /></p><p>Each SubmissionUnit might be grouped into one Submission. Each Submission might group one or more SubmissionUnit.<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>
ReviewableUnit Class	Name: groupedSubmissionUnit	Name: groupingReviewableUnit
Details: DESCRIPTION:<br /></p><p>Each SubmissionUnit might be grouped into one ReviewableUnit. Each ReviewableUnit always groups one or more SubmissionUnit.<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>
DocumentVersion Class	Name: includingSubmissionUnit	Name: includedDocumentVersion
Details: DESCRIPTION:<br /></p><p>Each SubmissionUnit always includes one or more DocumentVersion. Each DocumentVersion might be included in one or more SubmissionUnit.<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: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.

Object	Type	Connection	Direction	Notes
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):
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):