Study Conduct Sub-Domain::StudySitePersonnel

: Public Class

Created:	6/18/2008 2:28:56 PM
Modified:	8/26/2017 2:57:24 AM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{C9CF520C-1C36-4077-9A07-8FF0F71F5297}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View CM: Common, View PR: Protocol Representation, Study Versioning View, View SC: Study Conduct, SDTM 3.1.3 View, SDTM Disease Response (RS) Domain View, ClinicalTrials.gov, Participant Registration

DEFINITION: A person who performs a particular role within the context of a specific study site. EXAMPLE(S): Study Site Investigator, Study Site Research Coordinator OTHER NAME(S): NOTE(S): roleCode and primaryIndicator are redundant attributes when roleCode = "Principal Site Investigator" and primaryIndicator ="true".

Attributes
Associations To
Associations From
Tagged Values
Constraints
Other Links

Attribute

Public CD
roleCode

Details:

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

Map:C3PRv2.9=StudyPersonnel.roleCode
Map:C3PRv2.9=RoleBasedRecipient.role
Map:C3PRv2.9=StudyInvestigator.roleCode
Map:caAERSv2.2=RoleBasedRecipient.role
Map:caAERSv2.2=StudyPersonnel.roleCode
Map:CTGOV=Facility Contact Backup
Map:CTRPv1.0=StudySiteInvestigator.roleCode
Map:CTRPv1.0=StudyParticipationContact.roleCode
Map:CTRPv3.8=StudySiteContact.roleCode
Map:CTRR=Site Representative/ Investigator
Map:CTRv1.0=StudySitePersonnel.roleCode
Map:SDTM IGv3.1.3=TR.TREVAL
Map:SDTM IGv3.1.3=RS.RSEVAL
Map:SDTM IGv3.1.3=PE.PEEVAL
Map:SDTM IGv3.1.3=FA.FAEVAL
Map:SDTM IGv3.1.3=EG.EGEVAL
Map:SDTM IGv3.1.3=TU.TUEVAL
Map:Vendor1v1.1=StudySitePersonnel.roleCode

Notes:

DEFINITION: The coded value specifying a type of responsibility of the study site personnel. EXAMPLE(S): Principal Investigator, Sub Investigator, Facility Contact Backup OTHER NAME(S): NOTE(S): roleCode and primaryIndicator are redundant attributes when roleCode = "Principal Site Investigator" and primaryIndicator ="true".

Public BL
primaryIndicator

Details:

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

Map:CTRPv1.0=StudyParticipationContact.primaryIndicator
Map:CTRPv1.0=StudySiteInvestigator.primaryIndicator
Map:CTRPv3.8=StudySiteContact.primaryIndicator
Map:CTRv1.0=StudySitePersonnel.primaryIndicator
Map:Vendor1v1.1=StudySitePersonnel.primaryIndicator

Notes:

DEFINITION: Specifies whether this is the main or principal study site personnel. EXAMPLE(S): OTHER NAME(S): NOTE(S): roleCode and primaryIndicator are redundant attributes when roleCode = "Principal Site Investigator" and primaryIndicator ="true".

Public AD
postalAddress

Details:

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

Map:caAERSv2.2=Address.state > SiteResearchStaff
Map:caAERSv2.2=Address.street > SiteResearchStaff
Map:caAERSv2.2=Address.country > SiteResearchStaff
Map:caAERSv2.2=Address.city > SiteResearchStaff
Map:caAERSv2.2=Address.zip > SiteResearchStaff
Map:CTRPv1.0=StudyParticipationContact.postalAddress
Map:CTRPv1.0=StudySiteInvestigator.postalAddress
Map:CTRPv3.8=StudySiteContact.postalAddress
Map:CTRRr3=StudySiteContact.postalAddress
Map:CTRv1.0=StudySitePersonnel.postalAddress
Map:Vendor1v1.1=StudySitePersonnel.postalAddress

Notes:

DEFINITION: A contact point used to send physical forms of communication to the study site personnel. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Public BAG<TEL>
telecomAddress

Details:

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

Map:caAERSv2.2=ContactMechanismBasedRecipient.address
Map:CTGOV=Facility Contact - Ext
Map:CTGOV=Facility Contact - Email
Map:CTGOV=Facility Contact - Phone
Map:CTRPv1.0=StudySiteInvestigator.telecomAddress
Map:CTRPv1.0=StudyParticipationContact.telecomAddress
Map:CTRPv3.8=StudySiteContact.telecomAddress
Map:CTRv1.0=StudySitePersonnel.telecomAddress
Map:HCTv1.0=CDE 2517550:UML DEFAULT CD.Person Email Address
Map:NCI CRF Standard=CDE 2661003v1.0: Clinical Research Associate Person Telephone Number
Map:NCI CRF Standard=CDE 2661012v3.0: Clinical Research Associate Person Fax Number
Map:Vendor1v1.1=StudySitePersonnel.telecomAddress

Notes:

DEFINITION: A sequence of digits or characters used to identify a particular telephone, fax, or email of a study site personnel. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Public IVL<TS.DATETIME>
effectiveDateRange

Details:

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

Map:C3PR=HealthcareSiteInvestigator.statusDate
Map:C3PR=HealthcareSiteInvestigator.statusCode
Map:C3PRv2.9=StudyInvestigator.statusDate
Map:C3PRv2.9=StudyInvestigator.statusCode
Map:C3PRv2.9=StudyPersonnel.statusDate
Map:C3PRv2.9=StudyPersonnel.statusCode
Map:caAERSv2.2=StudyPersonnel.startDate
Map:caAERSv2.2=StudyPersonnel.endDate
Map:CTRPv1.0=StudyParticipationContact.statusCode
Map:CTRPv1.0=StudyParticipationContact.statusDateRange
Map:CTRPv1.0=StudySiteInvestigator.statusCode
Map:CTRPv1.0=StudySiteInvestigator.statusDateRange
Map:CTRPv3.8=FunctionalRole.statusDateRange
Map:CTRv1.0=StudySitePersonnel.effectiveDateRange
Map:Vendor1v1.1=StudySitePersonnel.effectiveDateRange

Notes:

DEFINITION: The date and time span for when the study site personnel is active. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Element	Source Role	Target Role
PlannedStudySite Class	Name: supportsStudySitePersonnel	Name: supportedPlannedStudySite
Details: DESCRIPTION:<br/>Each StudySitePersonnel might plan to perform a role for one PlannedStudySite. Each PlannedStudySite might have a role planned to be performed by one or more StudySitePersonnel.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
StudySite 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/>
ResearchStaff Class	Name: performedStudySitePersonnel	Name: performingResearchStaff
Details: DESCRIPTION:<br/>Each StudySitePersonnel might be a function performed by one ResearchStaff. Each ResearchStaff might function as one or more StudySitePersonnel.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
HealthcareProvider Class	Name: performedStudySitePersonnel	Name: performingHealthcareProvider
Details: DESCRIPTION:<br/>Each StudySitePersonnel might be a function performed by one HealthcareProvider. Each HealthcareProvider might function as one or more StudySitePersonnel.<br/><br/>DEFINITION:<br/>Indicates that the StudySitePersonnel role is being fulfilled by a HealthcareProvider.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>

Element	Source Role	Target Role
Study Class	Name: participatedStudy	Name: participatingStudySitePersonnel
Details: DESCRIPTION:<br/>Each Study might be participated in by one or more StudySitePersonnel. Each StudySitePersonnel might participate in one Study.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
PerformedProtocolDeviation Class	Name: implementedPerformedProtocolDeviation	Name: implementingStudySitePersonnel
Details: DESCRIPTION:<br/>Each PerformedProtocolDeviation might have management action implemented by one StudySitePersonnel. Each StudySitePersonnel might implement the management action for one or more PerformedProtocolDeviation.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
NotificationReceiver Class	Name: performedNotificationReceiver	Name: performingStudySitePersonnel
Details: DESCRIPTION:<br/>Each NotificationReceiver might be a function performed by one StudySitePersonnel. Each StudySitePersonnel might function as one or more NotificationReceiver.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>

Tag	Value
Map:C3PRv2.9	StudyPersonnel
Details:
Map:caAERSv2.2	StudyPersonnel
Details:
Map:CTGOV	Facility Contact
Details:
Map:CTRPv1.0	StudyParticipationContact
Details:
Map:CTRPv3.8	StudySiteContact
Details:
Map:CTRRr3	StudySiteContact
Details:
Map:CTRv1.0	StudySitePersonnel
Details:
Map:HL7SP	Study.performer3
Details:
Map:Vendor1v1.1	StudySitePersonnel
Details:

Constraint	Type	Status
be a function performed by Exclusive Or	Invariant	Approved
Details: A StudySitePersonnel is a function performed by one and only one of the following: ResearchStaff, HealthcareProvider.<br/>

Object	Type	Connection	Direction	Notes
StudySiteInvestigator	Class	Generalization	From	DESCRIPTION: Each StudySiteInvestigator always specializes one StudySitePersonnel. Each StudySitePersonnel might be specialized by one StudySiteInvestigator. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
StudySiteResearchCoordinator	Class	Generalization	From	DESCRIPTION: Each StudySiteResearchCoordinator always specializes one StudySitePersonnel. Each StudySitePersonnel might be specialized by one StudySiteResearchCoordinator. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):