Study Conduct Sub-Domain::StudySite

: Public Class

Created:	1/5/2005 10:35:40 PM
Modified:	8/26/2019 5:23:41 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 IM: Imaging, View PR: Protocol Representation, Study Versioning, View SC: Study Conduct, SDTM IG v3.1.3, CDISC Lab Data Model v1.0.1, Organization, Organization-Related Classes - no attributes, StudySite and StudySubject, Performer, Oncology & Imaging, Registering a Trial at ClinicalTrials.gov, Participant Registration, Lab-Related Classes, Study Management, National Biomedical Imaging Archive (NBIA), National Marrow Donor Program (NMDP), Structured Protocol - Operational Mode

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 DSET<ID>
identifier

Details:

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

Map:CDASHv1.1=DM.SITEID
Map:CDISCLabv1.0.1=Site.Site ID or Number
Map:CTRPv3.8=StudySite.localStudyProtocolIdentifier
Map:CTRv1.0=StudySite.identifier
Map:DICOM=Clinical Trial Subject Module - Clinical Trial Site ID (0012,0030)
Map:DICOM=Clinical Trial Context Module - Clinical Trial Site ID (0012,0030)
Map:HL7SP=StudySite.id
Map:NBIAv6.4=Trial_Site.trial_site_id
Map:SDTM IGv3.1.1=DM.SITEID
Map:SDTM IGv3.1.2=DM.SITEID
Map:SDTM IGv3.1.3=DM.SITEID
Map:SDTM IGv3.2=DM.SITEID

Notes:

DEFINITION: A unique symbol that establishes identity of the study site. EXAMPLE(S): OTHER NAME(S): NOTE(S):

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: Specifies whether this is the principal administrative organization responsible for the study. EXAMPLE(S): OTHER NAME(S): NOTE(S): Exception: A multi-site study with no single assigned coordination center; in this case, every participating organization can be named as lead organization.

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: An integer falling within minimum and maximum bounds that specifies how many experimental units are needed for enrollment at this site. EXAMPLE(S): The Mill Valley Clinic study site has determined their site accrual target for study XYZ to be 15 accruals. OTHER NAME(S): NOTE(S):

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

Notes:

DEFINITION: The intended period of time for the study site's participation in the study. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Public IVL<TS.DATETIME>
dateRange

Details:

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

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

Notes:

DEFINITION: The date and time span specifying when the site's participation in the study begins and ends. 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:C3PRv2.9=SiteStatusHistory.siteStudyStatus
Map:caAERSv2.2=StudySite.statusCode
Map:CTOM=StudySite.statusCode
Map:CTRPv1.0=StudyParticipation.statusCode
Map:CTRPv3.8=StudySite.(StudySiteOverallStatus)
Map:CTRPv3.8=FunctionalRole.statusCode
Map:CTRPv3.8=StudySiteOverallStatus.statusCode
Map:CTRv1.0=StudySite.statusCode

Notes:

DEFINITION: A coded value specifying the phase in the lifecycle of the study site. EXAMPLE(S): 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. OTHER NAME(S): NOTE(S):

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=FunctionalRole.statusDateRange
Map:CTRPv3.8=StudySite.accrualDateRange
Map:CTRPv3.8=StudySiteOverallStatus.statusDate
Map:CTRv1.0=StudySite.statusDate

Notes:

DEFINITION: The date (and time) on which the status is assigned to the study site. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Element	Source Role	Target Role
HealthcareFacility Class	Name: performedStudySite	Name: performingHealthcareFacility
Details: DESCRIPTION:<br/>Each StudySite might be a function performed by one HealthcareFacility. Each HealthcareFacility might function as one or more StudySite.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
StudyCountry Class	Name: managedStudySite	Name: managingStudyCountry
Details: DESCRIPTION:<br/>Each StudySite might be managed by one StudyCountry. Each StudyCountry might manage one or more StudySite.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Organization Class	Name: performedStudySite	Name: performingOrganization
Details: DESCRIPTION:<br/>Each StudySite might be a function performed by one Organization. Each Organization might function as one or more StudySite.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
StudyConduct Class	Name: executingStudySite	Name: executedStudyConduct
Details: DESCRIPTION:<br/>Each StudySite might execute one StudyConduct. Each StudyConduct might be executed at one or more StudySite.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>

Element	Source Role	Target Role
StudySiteProtocolVersionRelationship Class	Name: executedStudySiteProtocolVersionRelationship	Name: executingStudySite
Details: DESCRIPTION:<br/>Each StudySiteProtocolVersionRelationship always is executed at one StudySite. Each StudySite might execute one or more StudySiteProtocolVersionRelationship.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
StudySiteRelationship Class	Name: sourceStudySiteRelationship	Name: targetStudySite
Details: DESCRIPTION:<br/>Each StudySiteRelationship always has as target one StudySite. Each StudySite might be the target for one or more StudySiteRelationship.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
StudySiteResource Class	Name: usedStudySiteResource	Name: usingStudySite
Details: DESCRIPTION:<br/>Each StudySiteResource always is used at one StudySite. Each StudySite might use one or more StudySiteResource.<br/><br/>DEFINITION:<br/>Indicates resources intended to be or actually consumed by a particular study site.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
StudySiteRelationship Class	Name: targetStudySiteRelationship	Name: sourceStudySite
Details: DESCRIPTION:<br/>Each StudySiteRelationship always has as source one StudySite. Each StudySite might be the source for one or more StudySiteRelationship.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
StudySiteRecruitmentStatus Class	Name: describingStudySiteRecruitmentStatus	Name: describedStudySite
Details: DESCRIPTION:<br/>Each StudySiteRecruitmentStatus always describes one StudySite. Each StudySite might be described by one or more StudySiteRecruitmentStatus.<br/><br/>DEFINITION:<br/>Indicates the point-in-time recruitment status of a study from the perspective of the study site.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Activity Class	Name: hasContextActivity	Name: contextForStudySite
Details: DESCRIPTION:<br/>Each Activity might have as context one StudySite. Each StudySite might be the context for one or more Activity.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
OversightCommittee Class	Name: overseeingOversightCommittee	Name: overseenStudySite
Details: DESCRIPTION:<br/>Each OversightCommittee might oversee one or more StudySite. Each StudySite might be overseen by one or more OversightCommittee.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
StudySitePersonnel Class	Name: performingStudySitePersonnel	Name: performedStudySite
Details: DESCRIPTION:<br/>Each StudySitePersonnel might perform a role for one StudySite. Each StudySite might have a role performed by one or more StudySitePersonnel.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>

Tag	Value
Map:C3PRv2.9	StudySite
Details:
Map:C3PRv2.9	StudyOrganization
Details:
Map:caAERSv2.2	StudySite
Details:
Map:caAERSv2.2	StudyOrganization
Details:
Map:CDISCLabv1.0.1	Site
Details:
Map:CTGOV	Facility
Details:
Map:CTRPv1.0	StudyParticipation
Details:
Map:CTRPv3.8	StudySite
Details:
Map:CTRPv3.8	StudySiteOverallStatus
Details:
Map:CTRPv3.8	OrganizationFunctionalRole.functionCode
Details:
Map:CTRRr3	StudySite
Details:
Map:CTRv1.0	StudySite
Details:
Map:DICOM	Clinical Trial Context Module
Details:
Map:HL7SP	StudySite
Details:
Map:HL7SP	Study.performer1
Details:
Map:HL7SP	SubjectProtectionApproval
Details:
Map:HSDBv1.0	[Lead Organization].Organization Type
Details:
Map:LabViewer2.2	StudySite
Details:
Map:NBIAv6.4	Trial_Site
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).<br/>
execute Mandatory Qualifier	Invariant	Approved
Details: At least one of the following must be known for a StudySite: StudySiteProtocolVersionRelationship, StudyConduct.<br/>
be overseen by actualIndicator Qualifier	Invariant	Approved
Details: Only Organization (via OversightCommittee) with actualIndicator = "true" is valid.<br/>
be a function performed by actualIndicator Qualifier	Invariant	Approved
Details: Only Organization (via HealthcareFacility or direct association) with actualIndicator = "true" is valid.<br/>