RegulatoryApplicationSponsor

: Public Class

Created:	3/7/2007 11:20:55 AM
Modified:	2/23/2012 4:18:45 PM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{C6C52217-7B40-489e-BEBC-EBE4176E78BD}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View RG: Regulatory

DEFINITION: An organization or person that assumes responsibility for producing and submitting documentation to a regulatory authority to seek approval for testing, marketing and the continuation of marketing of new drugs or devices. EXAMPLE(S): pharmaceutical company OTHER NAME(S): NOTE(S):

Attributes
Associations To
Associations From
Tagged Values
Constraints

Attribute

Public IVL<TS.DATETIME>
effectiveDateRange

Details:

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

Map:CTRv1.0=RegulatoryApplicationSponsor.effectiveDateRange
Map:RPS2=(New content)

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The date and time span for when the regulatory application sponsor 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
Organization Class	Name: performedRegulatoryApplicationSponsor	Name: performingOrganization
Details: DESCRIPTION:<br /></p><p>Each RegulatoryApplicationSponsor might be a function performed by one Organization. Each Organization might function as one or more RegulatoryApplicationSponsor.<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>
HealthcareProvider Class	Name: performedRegulatoryApplicationSponsor	Name: performingHealthcareProvider
Details: DESCRIPTION:<br /></p><p>Each RegulatoryApplicationSponsor might be a function performed by one HealthcareProvider. Each HealthcareProvider might function as one or more RegulatoryApplicationSponsor.<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>

Element	Source Role	Target Role
Submission Class	Name: submittedSubmission	Name: submittingRegulatoryApplicationSponsor
Details: DESCRIPTION:<br /></p><p>Each Submission always is submitted by one RegulatoryApplicationSponsor. Each RegulatoryApplicationSponsor always submits 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	INDHolder
Details:
Map:CTRPv1.0	RegulatoryApplicationSponsor
Details:
Map:CTRRr3	RegulatoryApplicationSponsor
Details:
Map:CTRv1.0	RegulatoryApplicationSponsor
Details:
Map:ICSRr2	holder (in R_Product)
Details:
Map:ICSRr2	role (in R_Product)
Details:

Constraint	Type	Status
be a function performed by Exclusive Or	Invariant	Approved
Details: A RegulatoryApplicationSponsor might be a function performed by one and only one of the following: Organization, HealthcareProvider.
be a function performed by actualIndicator Qualifier	Invariant	Approved
Details: Only Organization with actualIndicator = "true" is valid.