: Public Class
Created: 1/5/2005 10:35:40 PM
Modified: 1/12/2018 9:33:36 AM
Project:
Advanced:
DEFINITION:<br/>A facility in which study activities are conducted. <br/><br/>EXAMPLE(S):<br/>The site where the study subject encounter occurs, or the site of the Investigator.<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Attribute
Public DSET<ID>
  identifier
Details:
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:SDTM IGv3.1.1=DM.SITEID
Map:SDTM IGv3.1.2=DM.SITEID
Map:SDTM IGv3.1.3=DM.SITEID
Notes: DEFINITION:<br/>A unique symbol that establishes identity of the study site.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public BL
  leadIndicator
Details:
Map:C3PR=StudySite.roleCode
Map:CTOM=StudySite.roleCode
Map:CTRv1.0=StudySite.leadIndicator
Notes: DEFINITION:<br/>Specifies whether this is the principal administrative organization responsible for the study. <br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>Exception: A multi-site study with no single assigned coordination center; in this case, every participating organization can be named as lead organization.<br/>
Public URG<INT.NONNEG>
  targetAccrualNumberRange
Details:
Map:C3PR=StudySite.targetAccrualNumber
Map:C3PRv2.9=StudySite.targetAccrualNumber
Map:CTOM=StudySite.targetAccrualNumber
Map:CTR&Rr2=Population planned numbers in EEA
Map:CTR&Rr2=Population planned numbers in MS
Map:CTRPv1.0=StudyParticipation.targetAccrualNumber
Map:CTRPv3.8=StudySite.targetAccrualNumber
Map:CTRRr3=StudySite.targetAccrualNumberRange
Map:CTRv1.0=StudySite.targetAccrualNumberRange
Notes: DEFINITION:<br/>An integer falling within minimum and maximum bounds that specifies how many experimental units are needed for enrollment at this site.<br/><br/>EXAMPLE(S):<br/>The Mill Valley Clinic study site has determined their site accrual target for study XYZ to be 15 accruals.<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public PQ.TIME
  plannedDuration
Details:
Map:CTR&Rr2=Estimated trial duration in MS years
Map:CTR&Rr2=Estimated trial duration in MS days
Map:CTR&Rr2=Estimated trial duration worldwide years
Map:CTR&Rr2=Estimated trial duration in MS months
Map:CTR&Rr2=Estimated trial duration worldwide months
Map:CTR&Rr2=Estimated trial duration worldwide days
Map:CTRRr3=Study.duration
Map:CTRv1.0=StudySite.plannedDuration
Notes: DEFINITION:<br/>The intended period of time for the study site's participation in the study.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public IVL<TS.DATETIME>
  dateRange
Details:
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:<br/>The date and time span specifying when the site's participation in the study begins and ends.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public CD
  statusCode
Details:
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=StudySite.(StudySiteOverallStatus)
Map:CTRPv3.8=StudySiteOverallStatus.statusCode
Map:CTRv1.0=StudySite.statusCode
Notes: DEFINITION:<br/>A coded value specifying the phase in the lifecycle of the study site.<br/><br/>EXAMPLE(S):<br/>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.<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public TS.DATETIME
  statusDate
Details:
Map:C3PRv2.9=SiteStatusHistory.startDate
Map:CTOM=StudySite.irbApprovalDate
Map:CTRPv1.0=StudyParticipation.statusDateRange
Map:CTRPv3.8=StudySiteOverallStatus.statusDate
Map:CTRPv3.8=StudySite.accrualDateRange
Map:CTRPv3.8=FunctionalRole.statusDateRange
Map:CTRv1.0=StudySite.statusDate
Notes: DEFINITION:<br/>The date (and time) on which the status is assigned to the study site.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Element Source Role Target Role
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/>
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/>
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/>
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/>
Element Source Role Target Role
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/>
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/>
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/>
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/>
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/>
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/>
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/>
Tag Value
Map:C3PRv2.9 StudyOrganization
Details:
 
Map:C3PRv2.9 StudySite
Details:
 
Map:caAERSv2.2 StudyOrganization
Details:
 
Map:caAERSv2.2 StudySite
Details:
 
Map:CDISCLabv1.0.1 Site
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:DICOM Clinical Trial Context Module
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).<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/>