: Public Class
Created: 7/26/2007 9:01:22 AM
Modified: 8/26/2017 2:57:22 AM
Project:
Advanced:
DEFINITION:<br/>A person who handles the administrative responsibilities of a study on behalf of the study investigator, acts as a liaison between study site and study sponsor, and reviews all data and records before a monitor's visit. <br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/>At some sites (primarily in academic settings) Clinical Research Coordinators are called (Clinical Research Associates) CRAs.<br/><br/>study coordinator, research coordinator, clinical coordinator, research nurse, protocol nurse<br/><br/>NOTE(S):<br/>The Study Research Coordinator for study XYZ may review medical records to determine if a particular patient may be eligible for the study.  If so, he will notify the investigator for further review.  The Coordinator may ensure eligibility is validated, register the subject, ensure the patient is managed per the protocol, collect and submit the subject study data, and respond to data queries.<br/>
Element Source Role Target Role
PerformedProtocolDeviation
Class  
Name: managedPerformedProtocolDeviation
 
Name: managingStudyResearchCoordinator
 
Details:
DESCRIPTION:<br/>Each PerformedProtocolDeviation might have management action determined by one StudyResearchCoordinator. Each StudyResearchCoordinator might determine 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/><br/>
Tag Value
Map:CTRRr3 StudyResearchCoordinator
Details:
 
Object Type Connection Direction Notes
StudyPersonnel Class Generalization To DESCRIPTION: Each StudyResearchCoordinator always specializes one StudyPersonnel. Each StudyPersonnel might be specialized by one StudyResearchCoordinator. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):