Regulatory Sub-Domain::RegulatoryAuthority

: Public <<DEPRECATED>> Class

Created:	2/13/2008 1:26:45 PM
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:	{80B5B6B0-06D9-4a58-8DFC-A4534CD520DD}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View CM: Common, View RG: Regulatory, Organization-Related Classes - no attributes, ClinicalTrials.gov

DEFINITION: Governmental bodies that have the power to pass and enforce laws. EXAMPLE(S): Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK, Food and Drug Administration (FDA) in the USA OTHER NAME(S): NOTE(S):

Attributes
Associations From
Tagged Values
Other Links

Attribute

Public CD
jurisdictionAuthorityCode

Details:

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

Map:CTR&Rr2=SA from NCA
Map:CTR&Rr2=SA (Scientific Advice) from CHMP
Map:CTR&Rr2=SUSAR Reporting to NCAs
Map:CTR&Rr2=SUSAR Reporting to EVCTM
Map:CTRPv3.8=RegulatoryAuthority.jurisdictionCode
Map:CTRRr3=RegulatoryAuthority.jurisdictionCode
Map:CTRv1.0=RegulatoryAuthority.jurisdictionAuthorityCode

Notes:

DEFINITION: A coded value specifying the type of governance over which an authority has to make laws and enforce them. EXAMPLE(S): The Food and Drug Administration (FDA) exercises responsibility for pharmacovigilance (jurisdictionAuthorityCode) in the United States (Place.identifierCode). OTHER NAME(S): NOTE(S):

Public IVL<TS.DATETIME>
effectiveDateRange

Details:

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

Map:CTRPv1.0=RegulatoryAuthority.statusCode
Map:CTRPv1.0=RegulatoryAuthority.statusDateRange
Map:CTRv1.0=RegulatoryAuthority.effectiveDateRange

Notes:

DEFINITION: The date and time span for when the regulatory authority is active. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Element	Source Role	Target Role
«DEPRECATED» RegulatoryAssessment 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/>
MaterialName Class	Name: approvedMaterialName	Name: approvingRegulatoryAuthority
Details: DESCRIPTION:<br/>Each MaterialName might be approved by one RegulatoryAuthority. Each RegulatoryAuthority might approve one or more MaterialName.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Place Class	Name: locatingPlace	Name: locatedRegulatoryAuthority
Details: DESCRIPTION:<br/>Each Place might be the location for one RegulatoryAuthority. Each RegulatoryAuthority might have jurisdiction over one or more Place.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>

Tag	Value
Map:AE	RegulatoryAuthority
Details:
Map:CTRPv1.0	RegulatoryAuthority
Details:
Map:CTRPv3.8	RegulatoryAuthority
Details:
Map:CTRRr3	RegulatoryAuthority
Details:
Map:CTRv1.0	RegulatoryAuthority
Details:
Map:ICSRr2	territorialAuthority (in R_Product)
Details:
Map:ICSRr2	Author2 (in R_Product)
Details:

Object	Type	Connection	Direction	Notes
OversightAuthority	Class	Generalization	To	DESCRIPTION: Each RegulatoryAuthority always specializes one OversightAuthority. Each OversightAuthority might be specialized by one RegulatoryAuthority. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):