: Public Class
Created: 6/18/2008 2:30:15 PM
Modified: 8/26/2017 2:57:23 AM
Project:
Advanced:
DEFINITION:<br/>A researcher at a study site who oversees multiple aspects of the study at a site, including protocol submission for IRB approval, participant recruitment, informed consent, data collection, and analysis.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Attribute
Public ID
  identifier
Details:
Map:CTRv1.0=StudySiteInvestigator.identifier
Map:SDTM IGv3.1.3=DM.INVID
Notes: DEFINITION:<br/>A unique symbol that establishes identity of the study site investigator.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S): <br/>Open issue: Need to know if this is actually an identifier specifically assigned to an investigator specific to a particular study and site.<br/>
Tag Value
Map:C3PRv2.9 StudyInvestigator
Details:
 
Map:CTGOV Investigators (at the protocol location)
Details:
 
Map:CTRPv1.0 StudySiteInvestigator
Details:
 
Map:CTRPv3.8 StudySiteInvestigator
Details:
 
Map:CTRv1.0 StudySiteInvestigator
Details:
 
Map:HL7SP Study.performer3
Details:
 
Constraint Type Status
be a function performed by Qualifier Invariant Approved
Details:
If the associated StudyProtocolVersion is an InterventionalStudyProtocolVersion then the StudySiteInvestigator must be a function performed by a HealthcareProvider.<br/>
Object Type Connection Direction Notes
StudySitePersonnel Class Generalization To DESCRIPTION: Each StudySiteInvestigator always specializes one StudySitePersonnel. Each StudySitePersonnel might be specialized by one StudySiteInvestigator. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):