Study Conduct Sub-Domain::StudySiteOversightStatus

: Public Class

Created:	1/28/2009 1:58:14 PM
Modified:	7/3/2019 3:18:30 PM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{DC4E864C-19E9-4ed6-811F-61DBCBD4BA71}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View IM: Imaging, Study Versioning, View SC: Study Conduct, StudySite and StudySubject, Oncology & Imaging, Registering a Trial at ClinicalTrials.gov, Participant Registration, Study Management, National Marrow Donor Program (NMDP)

DEFINITION: Describes the state of a study at a particular site as assigned by an oversight committee. EXAMPLE(S): request not submitted; submitted, pending; submitted, approved; submitted, exempt; submitted, denied; submission not required. OTHER NAME(S): NOTE(S):

Attributes
Associations To
Tagged Values
Constraints

Attribute

Public ST.SIMPLE
reviewBoardApprovalNumberText

Details:

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

Map:CTGOV=Board Approval Number
Map:CTRPv3.8=StudySite.reviewBoardApprovalNumber
Map:CTRR=IRB Approval Number
Map:CTRv1.0=StudySiteOversightStatus.reviewBoardApprovalNumberText
Map:DICOM=Clinical Trial Context Module - Clinical Trial Protocol Ethics Committee Approval Number (0012,0082)
Map:DICOM=Clinical Trial Subject Module - Clinical Trial Protocol Ethics Committee Approval Number (0012,0082)
Map:HCTv1.0=MD Anderson Specific Content: Protocol .IRB number
Map:HCTv1.0=MD Anderson Specific Content: Protocol .NIH-OBA Number
Map:HCTv1.0=MD Anderson Specific Content: Protocol .IBC number
Map:HSDBv1.0=[IRB].IRB number

Notes:

DEFINITION: A character string that is assigned by the review board upon approval of the protocol. EXAMPLE(S): 12-001234, 4-05, or any string defined by the review board. OTHER NAME(S): NOTE(S):

Public CD
reviewBoardProcessCode

Details:

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

Map:CTGOV=Board Approval Status
Map:CTRPv3.8=StudySite.reviewBoardApprovalStatusCode
Map:CTRR=IRB Review/Approval Status
Map:CTRv1.0=StudySiteOversightStatus.reviewBoardProcessCode
Map:HSDBv1.0=[IRB].IRB review type

Notes:

DEFINITION: A coded value specifying the phase in the lifecycle of the review board process. EXAMPLE(S): request not submitted; submitted, pending; submitted, approved; submitted, exempt; submitted, denied; submission not required OTHER NAME(S): NOTE(S): Please refer to the Review Board Process Status state transition diagram for further details.

Public TS.DATETIME
reviewBoardProcessDate

Details:

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

Map:C3PR=StudySite.irbApprovalDate
Map:C3PRv2.9=StudySiteStudyVersion.irbApprovalDate
Map:CTOM=StudySite.irbApprovalDate
Map:CTRv1.0=StudySiteOversightStatus.reviewBoardProcessDate
Map:HSDBv1.0=[IRB].IRB approval date
Map:PSCv2.6=AmendmentApproval.date

Notes:

DEFINITION: The date (and time) on which the Institutional Review Board (IRB) determined the status of this study protocol for execution at this site. EXAMPLE(S): OTHER NAME(S): Review Board Approval Date NOTE(S):

Public IVL<TS.DATETIME>
effectiveDateRange

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:
Transient:	False
Derived:	False
IsID:	False

Map:DICOM=Clinical Trial Context Module - Ethics Committee Approval Effectiveness Start Date (0012,0086)
Map:DICOM=Clinical Trial Context Module - Ethics Committee Approval Effectiveness End Date (0012,0087)

Notes:

DEFINITION: The date and time span specifying when the review board's oversight status (process code) begins and ends. EXAMPLE(S): OTHER NAME(S): Ethics Committee Approval Effectiveness Start and End Date NOTE(S):

Element	Source Role	Target Role
OversightCommittee Class	Name: assignedStudySiteOversightStatus	Name: assigningOversightCommittee
Details: DESCRIPTION:<br/>Each StudySiteOversightStatus might be assigned by one OversightCommittee. Each OversightCommittee might assign one or more StudySiteOversightStatus.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
StudySiteProtocolVersionRelationship Class	Name: describingStudySiteOversightStatus	Name: describedStudySiteProtocolVersionRelationship
Details: DESCRIPTION:<br/>Each StudySiteOversightStatus always describes one StudySiteProtocolVersionRelationship. Each StudySiteProtocolVersionRelationship might be described by one or more StudySiteOversightStatus.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>

Tag	Value
Map:CTRv1.0	StudySiteOversightStatus
Details:
Map:PSCv2.6	AmendmentApproval
Details:

Constraint	Type	Status
be assigned by actualIndicator Qualifier	Invariant	Approved
Details: Only Organization (via OversightCommittee) with actualIndicator = "true" is valid.<br/>