Study Conduct Sub-Domain::StudyCountryPersonnel

: Public Class

Created:	12/1/2016 4:22:03 PM
Modified:	8/26/2017 2:57:21 AM

Project:
Author:	jevans
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{BDF59BE6-ADEA-44dc-A404-57516319E0A1}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View CM: Common, View SC: Study Conduct

DEFINITION: A person who performs a particular role within the context of a specific study country. EXAMPLE(S): Study Country Investigator, Study Country Research Coordinator OTHER NAME(S): NOTE(S):

Attributes
Associations To
Tagged Values

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=StudyInvestigator.roleCode
Map:C3PRv2.9=RoleBasedRecipient.role
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=EG.EGEVAL
Map:SDTM IGv3.1.3=FA.FAEVAL
Map:SDTM IGv3.1.3=PE.PEEVAL
Map:SDTM IGv3.1.3=RS.RSEVAL
Map:SDTM IGv3.1.3=TR.TREVAL
Map:SDTM IGv3.1.3=TU.TUEVAL

Notes:

DEFINITION: The coded value specifying a type of responsibility of the study country 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

Notes:

DEFINITION: Specifies whether this is the main or principal study country 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.street > SiteResearchStaff
Map:caAERSv2.2=Address.state > SiteResearchStaff
Map:caAERSv2.2=Address.city > SiteResearchStaff
Map:caAERSv2.2=Address.zip > SiteResearchStaff
Map:caAERSv2.2=Address.country > 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

Notes:

DEFINITION: A contact point used to send physical forms of communication to the study country 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 - Phone
Map:CTGOV=Facility Contact - Email
Map:CTRPv1.0=StudyParticipationContact.telecomAddress
Map:CTRPv1.0=StudySiteInvestigator.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

Notes:

DEFINITION: A sequence of digits or characters used to identify a particular telephone, fax, or email of a study country 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=StudySiteInvestigator.statusDateRange
Map:CTRPv1.0=StudySiteInvestigator.statusCode
Map:CTRPv1.0=StudyParticipationContact.statusDateRange
Map:CTRPv1.0=StudyParticipationContact.statusCode
Map:CTRPv3.8=FunctionalRole.statusDateRange
Map:CTRv1.0=StudySitePersonnel.effectiveDateRange

Notes:

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

Element	Source Role	Target Role
StudyCountry Class	Name: performingStudyCountryPersonnel	Name: performedStudyCountry
Details: DESCRIPTION:<br/>Each StudyCountryPersonnel might perform a role for one StudyCountry. Each StudyCountry might have a role performed by one or more StudyCountryPersonnel.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>

Tag	Value
Map:Vendor1v1.1	StudySitePersonnel
Details: