OversightCommittee

: Public Class

Created:	7/25/2007 10:12:53 AM
Modified:	6/13/2012 10:41:50 AM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{DDB9B3D8-7835-49b4-9803-90F65D74D68C}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View SA: Statistical Analysis, View CM: Common, View RG: Regulatory, View SC: Study Conduct

DEFINITION: An organization that approves, monitors and reviews biomedical research to protect the rights, safety and welfare of the study subjects. This committee performs critical oversight functions for research conducted on human study subjects that are scientific, ethical, and regulatory. EXAMPLE(S): Institutional Review Board (IRB), ethics committee, research ethics board OTHER NAME(S): NOTE(S):

Attributes
Associations To
Associations From
Tagged Values
Other Links

Attribute

Public CD
typeCode

Details:

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

Map:CTOM=Data Monitoring Committee
Map:CTRPv1.0=OversightCommittee.typeCode
Map:CTRPv3.8=OversightCommittee.typeCode
Map:CTRR=IRB Organization
Map:CTRR=Oversight Authority
Map:CTRR=IRB Affiliation
Map:CTRRr3=OversightCommittee.typeCode
Map:CTRv1.0=OversightCommittee.typeCode
Map:HSDBv1.0=[IRB].IRB type

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the kind of oversight committee.#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;Adjudication Committee, IRB, Data Safety Monitoring Board#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;

Public IVL<TS.DATETIME>
effectiveDateRange

Details:

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

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

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The date (and time) span for when the oversight committee 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
StudySite Class	Name: overseeingOversightCommittee	Name: overseenStudySite
Details: DESCRIPTION:<br /></p><p>Each OversightCommittee might oversee one or more StudySite. Each StudySite might be overseen by one or more OversightCommittee.<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>
HealthcareFacility Class	Name: overseeingOversightCommittee	Name: overseenHealthcareFacility
Details: DESCRIPTION:<br /></p><p>Each OversightCommittee might oversee one or more HealthcareFacility. Each HealthcareFacility might be overseen by one or more OversightCommittee.<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
StudySiteOversightStatus Class	Name: assignedStudySiteOversightStatus	Name: assigningOversightCommittee
Details: DESCRIPTION:<br /></p><p>Each StudySiteOversightStatus might be assigned by one OversightCommittee. Each OversightCommittee might assign one or more StudySiteOversightStatus.<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>
Assessor Class	Name: performedAssessor	Name: performingOversightCommittee
Details: DESCRIPTION:<br /></p><p>Each Assessor might be a function performed by one OversightCommittee. Each OversightCommittee might function as one or more Assessor.<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>
DataMonitoringCommitteeCharterVersion Class	Name: governingDataMonitoringCommitteeCharterVersion	Name: governedOversightCommittee
Details: DESCRIPTION:<br /></p><p>Each DataMonitoringCommitteeCharterVersion always governs one OversightCommittee. Each OversightCommittee might be governed by one or more DataMonitoringCommitteeCharterVersion.<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:CTOM	HealthcareSiteParticipantRole.roleCode
Details:
Map:CTRPv1.0	OversightCommittee
Details:
Map:CTRPv3.8	OversightCommittee
Details:
Map:CTRRr3	OversightCommittee
Details:
Map:CTRv1.0	OversightCommittee
Details:
Map:HL7SP	Verifier
Details:
Map:HL7SP	EthicalCommittee
Details:
Map:HL7SP	ServiceProvider
Details:
Map:HSDBv1.0	[Lead Organization] .Organization Type
Details:

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