StudySite

: Public Class

Created:	1/5/2005 10:35:40 PM
Modified:	3/23/2015 5:00:11 PM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{67703B94-C0DB-4831-B480-B8C3A3ADFB2E}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View CM: Common, View PR: Protocol Representation, Study Versioning View, View SC: Study Conduct

DEFINITION: A facility in which study activities are conducted. EXAMPLE(S): The site where the study subject encounter occurs, or the site of the Investigator. OTHER NAME(S): NOTE(S):

Attributes
Associations To
Associations From
Tagged Values
Constraints

Attribute

Public II
identifier

Details:

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

Map:CDASHv1.1=DM.SITEID
Map:CTRPv3.8=StudySite.localStudyProtocolIdentifier
Map:CTRv1.0=StudySite.identifier
Map:HL7SP=StudySite.id
Map:SDTM IGv3.1.1=DM.SITEID
Map:SDTM IGv3.1.2=DM.SITEID

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A unique symbol that establishes identity of the study site.#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;

Public BL
leadIndicator

Details:

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

Map:C3PR=StudySite.roleCode
Map:CTOM=StudySite.roleCode
Map:CTRv1.0=StudySite.leadIndicator

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Specifies whether this is the principal administrative organization responsible for the study. #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;#lt;p#gt;Exception: A multi-site study with no single assigned coordination center; in this case, every participating organization can be named as lead organization.#lt;br /#gt;#lt;/p#gt;

Public URG<INT.NONNEG>
targetAccrualNumberRange

Details:

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

Map:C3PR=StudySite.targetAccrualNumber
Map:C3PRv2.9=StudySite.targetAccrualNumber
Map:CTOM=StudySite.targetAccrualNumber
Map:CTR&Rr2=Population planned numbers in MS
Map:CTR&Rr2=Population planned numbers in EEA
Map:CTRPv1.0=StudyParticipation.targetAccrualNumber
Map:CTRPv3.8=StudySite.targetAccrualNumber
Map:CTRRr3=StudySite.targetAccrualNumberRange
Map:CTRv1.0=StudySite.targetAccrualNumberRange

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;An integer falling within minimum and maximum bounds that specifies how many experimental units are needed for enrollment at this site.#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;The Mill Valley Clinic study site has determined their site accrual target for study XYZ to be 15 accruals.#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 PQ.TIME
plannedDuration

Details:

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

Map:CTR&Rr2=Estimated trial duration in MS years
Map:CTR&Rr2=Estimated trial duration worldwide months
Map:CTR&Rr2=Estimated trial duration worldwide years
Map:CTR&Rr2=Estimated trial duration worldwide days
Map:CTR&Rr2=Estimated trial duration in MS months
Map:CTR&Rr2=Estimated trial duration in MS days
Map:CTRRr3=Study.duration
Map:CTRv1.0=StudySite.plannedDuration

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The intended period of time for the study site's participation in the study.#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;

Public IVL<TS.DATETIME>
dateRange

Details:

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

Map:C3PR=StudySite.startDate
Map:C3PR=StudySite.endDate
Map:CTGOV=StudySite.startDate
Map:CTOM=StudySite.stopDate
Map:CTRPv1.0=StudyParticipation.dateRange
Map:CTRv1.0=StudySite.dateRange

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The date and time span specifying when the site's participation in the study begins and ends.#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;

Public CD
statusCode

Details:

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

Map:C3PRv2.9=SiteStatusHistory.siteStudyStatus
Map:caAERSv2.2=StudySite.statusCode
Map:CTOM=StudySite.statusCode
Map:CTRPv1.0=StudyParticipation.statusCode
Map:CTRPv3.8=FunctionalRole.statusCode
Map:CTRPv3.8=StudySiteOverallStatus.statusCode
Map:CTRPv3.8=StudySite.(StudySiteOverallStatus)
Map:CTRv1.0=StudySite.statusCode

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the phase in the lifecycle of the study site.#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;In Review, Approved, Active, Closed to Accrual, Closed to Accrual and Intervention, Temporary Closed to Accrual, Temporary Closed to Accrual and Intervention, Disapproved, Withdrawn, Administratively complete.#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 TS.DATETIME
statusDate

Details:

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

Map:C3PRv2.9=SiteStatusHistory.startDate
Map:CTOM=StudySite.irbApprovalDate
Map:CTRPv1.0=StudyParticipation.statusDateRange
Map:CTRPv3.8=StudySite.accrualDateRange
Map:CTRPv3.8=FunctionalRole.statusDateRange
Map:CTRPv3.8=StudySiteOverallStatus.statusDate
Map:CTRv1.0=StudySite.statusDate

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The date (and time) on which the status is assigned to the study site.#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;

Public CD
accrualStatusCode

Details:

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

Map:CTRv1.0=StudySite.accrualStatusCode

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the phase in the lifecycle of a participating site relative to the enrollment of additional experimental units in the given study.#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;Open to accrual#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Closed to accrual#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Temporarily closed to accrual#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Pending accrual#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;#lt;p#gt;Please refer to the Study Site Accrual Status state transition diagram for further details.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The accrual status of a study site may overlap with the overall status of the study and study site status. This overlap needs to be clearly differentiated. (See tracker issue 29398). A proposed solution is to eliminate the study site accrual status codes and adopt the CTRP values for study site status code. #lt;br /#gt;#lt;/p#gt;

Public TS.DATETIME
accrualStatusDate

Details:

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

Map:CTRv1.0=StudySite.accrualStatusDate

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The date (and time) on which the accrual status is established.#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
StudyConduct Class	Name: executingStudySite	Name: executedStudyConduct
Details: DESCRIPTION:<br /></p><p>Each StudySite might execute one StudyConduct. Each StudyConduct might be executed at one or more StudySite.<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>
Organization Class	Name: performedStudySite	Name: performingOrganization
Details: DESCRIPTION:<br /></p><p>Each StudySite might be a function performed by one Organization. Each Organization might function as one or more StudySite.<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: performedStudySite	Name: performingHealthcareFacility
Details: DESCRIPTION:<br /></p><p>Each StudySite might be a function performed by one HealthcareFacility. Each HealthcareFacility might function as one or more StudySite.<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
StudySiteResource Class	Name: usedStudySiteResource	Name: usingStudySite
Details: DESCRIPTION:<br /></p><p>Each StudySiteResource always is used at one StudySite. Each StudySite might use one or more StudySiteResource.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p>Indicates resources intended to be or actually consumed by a particular study site.<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>
StudySiteRecruitmentStatus Class	Name: describingStudySiteRecruitmentStatus	Name: describedStudySite
Details: DESCRIPTION:<br /></p><p>Each StudySiteRecruitmentStatus always describes one StudySite. Each StudySite might be described by one or more StudySiteRecruitmentStatus.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p>Indicates the point-in-time recruitment status of a study from the perspective of the study site.<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>
StudySiteProtocolVersionRelationship Class	Name: executedStudySiteProtocolVersionRelationship	Name: executingStudySite
Details: DESCRIPTION:<br /></p><p>Each StudySiteProtocolVersionRelationship always is executed at one StudySite. Each StudySite might execute one or more StudySiteProtocolVersionRelationship.<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>
StudySitePersonnel Class	Name: performingStudySitePersonnel	Name: performedStudySite
Details: DESCRIPTION:<br /></p><p>Each StudySitePersonnel might perform a role for one StudySite. Each StudySite might have a role performed by one or more StudySitePersonnel.<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>
PerformedAdministrativeActivity Class	Name: performedPerformedAdministrativeActivity	Name: performingStudySite
Details: DESCRIPTION:<br /></p><p>Each PerformedAdministrativeActivity might be performed at one StudySite. Each StudySite might perform one or more PerformedAdministrativeActivity.<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>
OversightCommittee 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>

Tag	Value
Map:C3PRv2.9	StudyOrganization
Details:
Map:C3PRv2.9	StudySite
Details:
Map:caAERSv2.2	StudyOrganization
Details:
Map:caAERSv2.2	StudySite
Details:
Map:CTGOV	Facility
Details:
Map:CTRPv1.0	StudyParticipation
Details:
Map:CTRPv3.8	OrganizationFunctionalRole.functionCode
Details:
Map:CTRPv3.8	StudySite
Details:
Map:CTRPv3.8	StudySiteOverallStatus
Details:
Map:CTRRr3	StudySite
Details:
Map:CTRv1.0	StudySite
Details:
Map:HL7SP	SubjectProtectionApproval
Details:
Map:HL7SP	StudySite
Details:
Map:HL7SP	Study.performer1
Details:
Map:HSDBv1.0	[Lead Organization].Organization Type
Details:
Map:LabViewer2.2	StudySite
Details:
Map:PSC	StudySite
Details:
Map:PSCv2.6	StudySite
Details:

Constraint	Type	Status
be a function performed by Exclusive Or	Invariant	Approved
Details: A StudySite is a function performed by one and only one of the following: HealthcareFacility or Organization (serving as a StudySite but is not a HealthcareFacility).
execute Mandatory Qualifier	Invariant	Approved
Details: At least one of the following must be known for a StudySite: StudySiteProtocolVersionRelationship, StudyConduct.
be overseen by actualIndicator Qualifier	Invariant	Approved
Details: Only Organization (via OversightCommittee) with actualIndicator = "true" is valid.
be a function performed by actualIndicator Qualifier	Invariant	Approved
Details: Only Organization (via HealthcareFacility or direct association) with actualIndicator = "true" is valid.