Regulatory Sub-Domain::RegulatoryAssessment

: Public <<DEPRECATED>> Class

Created:	2/13/2008 11:08:32 AM
Modified:	8/26/2017 2:46:29 AM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{24A1E032-046F-4d2a-8A99-3F58397A3828}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View RG: Regulatory, ClinicalTrials.gov

DEFINITION: An evaluation of a submission by a regulatory body. EXAMPLE(S): The FDA evaluates a submission for a new drug or device. OTHER NAME(S): NOTE(S):

Attributes
Associations To
Associations From
Tagged Values
Constraints

Attribute

Public DSET<ID>
identifier

Details:

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

Map:AE=Authorization.approvalId
Map:CTR&Rr2=MA number
Map:CTR&Rr2=Orphan drug number
Map:CTR&Rr2=Manufacturer authorisation number
Map:CTRPv1.0=TherapeuticProduct.identifier
Map:CTRRr3=RegulatoryAssessment.identifier
Map:CTRv1.0=RegulatoryAssessment.identifier
Map:ICSRr2=Approval.id (in R_Product)

Notes:

DEFINITION: A unique symbol that establishes identity of the regulatory assessment. EXAMPLE(S): New Drug Application (NDA) number, Investigational New Drug (IND) number, Biologic License Application (BLA), Premarket Approval (PMA), 510K OTHER NAME(S): NOTE(S):

Public CD
typeCode

Details:

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

Map:CTRv1.0=RegulatoryAssessment.typeCode
Map:HSDBv1.0=[IND/IDE] .Grantor
Map:ICSRr2=Approval.code (in R_Product)

Notes:

DEFINITION: A coded value specifying the approval process used by the regulatory authority. EXAMPLE(S): FDA's Center for Devices and Radiological Health (CDRH) Process, FDA's Center for Drug Evaluation and Research (CDER) Process OTHER NAME(S): NOTE(S):

Public CD
resultCode

Details:

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

Map:CTGOV=Expanded Access Status
Map:CTR&Rr2=IEC Opinion Given
Map:CTR&Rr2=GMP MP Auth granted
Map:CTRPv3.8=StudyIndIde.expandedAccessStatusCode
Map:CTRR=Expanded access indicator
Map:CTRRr3=RegulatoryAssessment.assessmentCode
Map:CTRRr3=StudyAgent.expandedAccessStatusCode
Map:CTRv1.0=RegulatoryAssessment.resultCode

Notes:

DEFINITION: A coded value specifying the regulatory designation made by the regulatory authority. EXAMPLE(S): For regular submissions the code can be: approved, not approvable, approvable, complete response or cleared. For expanded access submissions the code can be: Available, No longer available, Temporarily not available, or Approved for marketing. OTHER NAME(S): NOTE(S): For some submissions, there are business processes that will make "default" action based on timelines --i.e., if no action is taken, then the submission is "approved". For a submission, there may be multiple regulatory assessments that correspond to the state transitions for a submission, but only one regulatory assessment is true at a given time. A submission can first be "approvable" and then when the data is complete, a new regulatory assessment can be made that is "approved".

Public CD
reasonCode

Details:

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

Map:CTR&Rr2=Reason for no authorisation
Map:CTR&Rr2=IEC Opinion not favourable reasons
Map:CTRRr3=RegulatoryAssessment.assessmentReasonCode
Map:CTRv1.0=RegulatoryAssessment.reasonCode

Notes:

DEFINITION: A coded value specifying the rationale for a regulatory designation. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Public CD
statusCode

Details:

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

Map:CTRRr3=RegulatoryAssessment.statusCode

Notes:

DEFINITION: A coded value specifying the phase in the lifecycle of the assessment. EXAMPLE(S): pending, complete OTHER NAME(S): NOTE(S):

Public TS.DATETIME
completionDate

Details:

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

Map:CTGOV=Expanded Access Status
Map:CTR&Rr2=IEC Opinion date
Map:CTRR=Expanded access indicator
Map:CTRRr3=RegulatoryAssessment.assessmentDate
Map:CTRv1.0=RegulatoryAssessment.completionDate
Map:ICSRr2=Author2.time (in R_Product)
Map:ICSRr2=Approval.effectiveTime (in R_Product)

Notes:

DEFINITION: The date (and time) on which this particular assessment is completed. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Public TS.DATETIME
expectedResubmissionDate

Details:

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

Map:CTRRr3=RegulatoryAssessment.expectedResubmissionDate

Notes:

DEFINITION: The date on which the resubmission of the regulatory application is expected. EXAMPLE(S): OTHER NAME(S): NOTE(S): Used only when RegulatoryAssessment.statusCode is not complete. Regulatory authorities typically assign a resubmission deadline such as 30 days.

Element	Source Role	Target Role
«DEPRECATED» RegulatoryAuthority Class	Name: performedRegulatoryAssessment	Name: performingRegulatoryAuthority
Details: DESCRIPTION:<br/>Each RegulatoryAssessment always is performed by one RegulatoryAuthority. Each RegulatoryAuthority might perform one or more RegulatoryAssessment.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>

Element	Source Role	Target Role
«DEPRECATED» Submission Class	Name: evaluatedSubmission	Name: evaluatingRegulatoryAssessment
Details: DESCRIPTION:<br/>Each Submission might be evaluated in one RegulatoryAssessment. Each RegulatoryAssessment always evaluates 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:AE	Authorization
Details:
Map:CTRRr3	RegulatoryAssessment
Details:
Map:CTRv1.0	RegulatoryAssessment
Details:
Map:ICSRr2	Approval (in R_Product)
Details:

Constraint	Type	Status
is a function performed by actualIndicator Qualifier	Invariant	Approved
Details: Only Organization (via OversightAuthority) with actualIndicator = "true" is valid.<br/>