StudyPersonnel

: Public Class

Created:	6/18/2008 2:27:17 PM
Modified:	7/9/2012 4:11:58 PM

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, Study Versioning View, View SC: Study Conduct

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=StudyPersonnel.roleCode
Map:C3PRv2.9=RoleBasedRecipient.role
Map:C3PRv2.9=StudyInvestigator.roleCode
Map:caAERSv2.2=StudyInvestigator.roleCode
Map:caAERSv2.2=RoleBasedRecipient.role
Map:CTGOV=Overall Study Officials
Map:CTGOV=Central Contact Backup
Map:CTGOV=Central Contact
Map:CTGOV=Overall Study Officials - Official's Role
Map:CTOM=StudyInvestigator.responsibilityRoleCode
Map:CTR&Rr2=Further information contact name
Map:CTRPv1.0=StudyInvestigator.roleCode
Map:CTRPv1.0=StudyContact.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:WHO=Contact for Scientific Queries
Map:WHO=Contact for Public Queries
Map:WHO=Contact for Public Queries - type
Map:WHO=Contact for Scientific Queries - type

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the type of responsibility of the study personnel.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Study Principal Investigator, Coordinating Investigator, Study Director, Study Chair, Public Queries, Scientific Queries, Scientific Leadership, Registrar, Study Coordinator.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;roleCode and primaryIndicator are redundant attributes when roleCode = "Principal Investigator" and primaryIndicator ="true".#lt;br /#gt;#lt;/p#gt;

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

Notes:

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

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=Further information contact Country
Map:CTR&Rr2=Further information contact Post Code
Map:CTR&Rr2=Investigator Post Code
Map:CTR&Rr2=Investigator Town/City
Map:CTR&Rr2=Investigator Street Address
Map:CTR&Rr2=Contact point for further information on the trial Street Address
Map:CTR&Rr2=Further information contact Town/City
Map:CTR&Rr2=Investigator 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] .Zip/Postal code
Map:HSDBv1.0=[Principal Investigator] .State/Province
Map:HSDBv1.0=[Principal Investigator] .City
Map:HSDBv1.0=[Principal Investigator] .Street Address
Map:HSDBv1.0=[Principal Investigator] .Country
Map:WHO=Contact for Public Queries - country
Map:WHO=Contact for Public Queries - zip
Map:WHO=Contact for Scientific Queries - address
Map:WHO=Contact for Public Queries - city
Map:WHO=Contact for Scientific Queries - city
Map:WHO=Contact for Public Queries - address
Map:WHO=Contact for Scientific Queries - zip
Map:WHO=Contact for Scientific Queries - country

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A contact point used to send physical forms of communication to the study personnel.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;

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=Central Contact - Phone
Map:CTGOV=Central Contact - Email
Map:CTGOV=Central Contact - Ext
Map:CTGOV=Responsible Party - Contact Information
Map:CTR&Rr2=Further information contact Fax
Map:CTR&Rr2=Investigator Fax
Map:CTR&Rr2=Investigator Email
Map:CTR&Rr2=Further information contact Telephone
Map:CTR&Rr2=Investigator Telephone
Map:CTR&Rr2=Further information contact E-mail
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] .URL
Map:HSDBv1.0=[Principal Investigator] .FAX
Map:HSDBv1.0=[Principal Investigator] .Phone
Map:HSDBv1.0=[Principal Investigator] .Email Address
Map:HSDBv1.0=[Principal Investigator] .TTY
Map:WHO=Contact for Scientific Queries - telephone
Map:WHO=Contact for Scientific Queries - email
Map:WHO=Contact for Public Queries - email
Map:WHO=Contact for Public Queries - telephone

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A sequence of digits or characters used to identify a particular telephone, fax, or email of the study personnel.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;

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=StudyInvestigator.statusDate
Map:C3PRv2.9=StudyPersonnel.statusCode
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.statusDateRange
Map:CTRPv1.0=StudyInvestigator.statusCode
Map:CTRPv1.0=StudyContact.statusCode
Map:CTRPv1.0=StudyInvestigator.statusDateRange
Map:CTRPv3.8=FunctionalRole.statusDateRange
Map:CTRv1.0=StudyPersonnel.effectiveDateRange
Map:HL7SP=Investigator.statusCode

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The date and time span for when the study personnel is active.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;

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

Element	Source Role	Target Role
NotificationReceiver Class	Name: performedNotificationReceiver	Name: performingStudyPersonnel
Details: DESCRIPTION:<br /></p><p>Each NotificationReceiver might be a function performed by one StudyPersonnel. Each StudyPersonnel might function as one or more NotificationReceiver.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>

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:

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.

Object	Type	Connection	Direction	Notes
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):
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):