Study Conduct Sub-Domain::StudyPersonnel

: Public Class

Created:	6/18/2008 2:27:17 PM
Modified:	8/26/2017 2:57:22 AM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{30330843-789A-4fa7-8F61-5BD24F71B6CD}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View CM: Common, Study Versioning View, View SC: Study Conduct, SDTM 3.1.3 View, SDTM Disease Response (RS) Domain View, ClinicalTrials.gov, Participant Registration, CDISC Lab Data Model v1.0.1

DEFINITION: A person who performs a particular role within the context of a specific study. EXAMPLE(S): Study Principal Investigator, Coordinating Investigator, Study Director, Study Chair, Public Queries, Scientific Queries, Scientific Leadership OTHER NAME(S): NOTE(S):

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:C3PR=StudyPersonnel.roleCode
Map:C3PR=StudyInvestigator.roleCode
Map:C3PRv2.9=RoleBasedRecipient.role
Map:C3PRv2.9=StudyPersonnel.roleCode
Map:C3PRv2.9=StudyInvestigator.roleCode
Map:caAERSv2.2=RoleBasedRecipient.role
Map:caAERSv2.2=StudyInvestigator.roleCode
Map:CTGOV=Overall Study Officials
Map:CTGOV=Overall Study Officials - Official's Role
Map:CTGOV=Central Contact Backup
Map:CTGOV=Central Contact
Map:CTOM=StudyInvestigator.responsibilityRoleCode
Map:CTR&Rr2=Further information contact name
Map:CTRPv1.0=StudyContact.roleCode
Map:CTRPv1.0=StudyInvestigator.roleCode
Map:CTRPv3.8=StudyContact.roleCode
Map:CTRR=Responsible Contact Person
Map:CTRRr3=StudyColleague.roleCode
Map:CTRv1.0=StudyPersonnel.roleCode
Map:FDA HL7 SD SD DSTU2012=plannedStudy/performer.functionCode
Map:HL7SP=Investigator.code
Map:HSDBv1.0=[IND/IDE] .Holder Type
Map:SDTM IGv3.1.3=FA.FAEVAL
Map:SDTM IGv3.1.3=RS.RSEVAL
Map:SDTM IGv3.1.3=TR.TREVAL
Map:SDTM IGv3.1.3=EG.EGEVAL
Map:SDTM IGv3.1.3=PE.PEEVAL
Map:SDTM IGv3.1.3=TU.TUEVAL
Map:Vendor1v1.1=StudyPersonnel.roleCode
Map:WHO=Contact for Public Queries
Map:WHO=Contact for Scientific Queries - type
Map:WHO=Contact for Scientific Queries
Map:WHO=Contact for Public Queries - type

Notes:

DEFINITION: A coded value specifying the type of responsibility of the study personnel. EXAMPLE(S): Study Principal Investigator, Coordinating Investigator, Study Director, Study Chair, Public Queries, Scientific Queries, Scientific Leadership, Registrar, Study Coordinator. OTHER NAME(S): NOTE(S): roleCode and primaryIndicator are redundant attributes when roleCode = "Principal 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=StudyInvestigator.primaryIndicator
Map:CTRPv1.0=StudyContact.primaryIndicator
Map:CTRv1.0=StudyPersonnel.primaryIndicator
Map:Vendor1v1.1=StudyPersonnel.primaryIndicator

Notes:

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

Public AD
postalAddress

Details:

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

Map:CTGOV=Responsible Party - Contact Information
Map:CTR&Rr2=Investigator Country
Map:CTR&Rr2=Further information contact Town/City
Map:CTR&Rr2=Contact point for further information on the trial Street Address
Map:CTR&Rr2=Investigator Street Address
Map:CTR&Rr2=Further information contact Post Code
Map:CTR&Rr2=Investigator Town/City
Map:CTR&Rr2=Investigator Post Code
Map:CTR&Rr2=Further information contact Country
Map:CTRPv1.0=StudyContact.postalAddress
Map:CTRPv1.0=StudyInvestigator.postalAddress
Map:CTRPv3.8=StudyContact.postalAddress
Map:CTRR=Responsible Contact Person
Map:CTRRr3=StudyColleague.postalAddress
Map:CTRv1.0=StudyPersonnel.postalAddress
Map:HSDBv1.0=[Principal Investigator] .City
Map:HSDBv1.0=[Principal Investigator] .Zip/Postal code
Map:HSDBv1.0=[Principal Investigator] .Street Address
Map:HSDBv1.0=[Principal Investigator] .State/Province
Map:HSDBv1.0=[Principal Investigator] .Country
Map:Vendor1v1.1=StudyPersonnel.postalAddress
Map:WHO=Contact for Scientific Queries - zip
Map:WHO=Contact for Public Queries - country
Map:WHO=Contact for Scientific Queries - address
Map:WHO=Contact for Public Queries - city
Map:WHO=Contact for Public Queries - address
Map:WHO=Contact for Scientific Queries - country
Map:WHO=Contact for Scientific Queries - city
Map:WHO=Contact for Public Queries - zip

Notes:

DEFINITION: A contact point used to send physical forms of communication to the study 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=Responsible Party - Contact Information
Map:CTGOV=Central Contact - Ext
Map:CTGOV=Central Contact - Phone
Map:CTGOV=Central Contact - Email
Map:CTR&Rr2=Further information contact E-mail
Map:CTR&Rr2=Investigator Telephone
Map:CTR&Rr2=Further information contact Telephone
Map:CTR&Rr2=Further information contact Fax
Map:CTR&Rr2=Investigator Fax
Map:CTR&Rr2=Investigator Email
Map:CTRPv1.0=StudyContact.telecomAddress
Map:CTRPv1.0=StudyInvestigator.telecomAddress
Map:CTRPv3.8=StudyContact.telecomAddress
Map:CTRR=Responsible Contact Person
Map:CTRRr3=StudyColleague.telecomAddress
Map:CTRv1.0=StudyPersonnel.telecomAddress
Map:HSDBv1.0=[Principal Investigator] .TTY
Map:HSDBv1.0=[Principal Investigator] .URL
Map:HSDBv1.0=[Principal Investigator] .Email Address
Map:HSDBv1.0=[Principal Investigator] .FAX
Map:HSDBv1.0=[Principal Investigator] .Phone
Map:Vendor1v1.1=StudyPersonnel.telecomAddress
Map:WHO=Contact for Public Queries - telephone
Map:WHO=Contact for Public Queries - email
Map:WHO=Contact for Scientific Queries - email
Map:WHO=Contact for Scientific Queries - telephone

Notes:

DEFINITION: A sequence of digits or characters used to identify a particular telephone, fax, or email of the study 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=StudyInvestigator.statusCode
Map:C3PRv2.9=StudyPersonnel.statusCode
Map:C3PRv2.9=StudyInvestigator.statusDate
Map:C3PRv2.9=StudyInvestigator.statusCode
Map:C3PRv2.9=StudyPersonnel.statusDate
Map:caAERSv2.2=StudyInvestigator.startDate
Map:caAERSv2.2=StudyInvestigator.endDate
Map:CTOM=StudyInvestigator.statusCode
Map:CTRPv1.0=StudyContact.statusCode
Map:CTRPv1.0=StudyInvestigator.statusCode
Map:CTRPv1.0=StudyInvestigator.statusDateRange
Map:CTRPv1.0=StudyContact.statusDateRange
Map:CTRPv3.8=FunctionalRole.statusDateRange
Map:CTRv1.0=StudyPersonnel.effectiveDateRange
Map:HL7SP=Investigator.statusCode
Map:Vendor1v1.1=StudyPersonnel.effectiveDateRange

Notes:

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

Element	Source Role	Target Role
StudyProtocolVersion Class	Name: performedStudyPersonnel	Name: performingStudyProtocolVersion
Details: DESCRIPTION:<br/>Each StudyPersonnel might perform a role for one StudyProtocolVersion. Each StudyProtocolVersion might have a role performed by one or more StudyPersonnel.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
StudyConduct Class	Name: performingStudyPersonnel	Name: performedStudyConduct
Details: DESCRIPTION:<br/>Each StudyPersonnel might perform a role for one StudyConduct. Each StudyConduct might have a role performed by one or more StudyPersonnel.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
HealthcareProvider Class	Name: performedStudyPersonnel	Name: performingHealthcareProvider
Details: DESCRIPTION:<br/>Each StudyPersonnel might be a function performed by one HealthcareProvider. Each HealthcareProvider might function as one or more StudyPersonnel.<br/><br/>DEFINITION:<br/>Indicates that the StudyPersonnel role is being fulfilled by a HealthcareProvider<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
ResearchStaff Class	Name: performedStudyPersonnel	Name: performingResearchStaff
Details: DESCRIPTION:<br/>Each StudyPersonnel might be a function performed by one ResearchStaff. Each ResearchStaff might function as one or more StudyPersonnel.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>

Element	Source Role	Target Role
Study Class	Name: participatedStudy	Name: participatingStudyPersonnel
Details: DESCRIPTION:<br/>Each Study might be participated in by one or more StudyPersonnel. Each StudyPersonnel might participate in one Study.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
NotificationReceiver Class	Name: performedNotificationReceiver	Name: performingStudyPersonnel
Details: DESCRIPTION:<br/>Each NotificationReceiver might be a function performed by one StudyPersonnel. Each StudyPersonnel 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:CTGOV	Coordinating investigator
Details:
Map:CTRPv3.8	StudyContact
Details:
Map:CTRRr3	StudyColleague
Details:
Map:CTRv1.0	StudyPersonnel
Details:
Map:Vendor1v1.1	StudyPersonnel
Details:

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

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