1. Chicken Soup for the Busy Coordinator
(June 2010)
The Clinical Research Coordinator’s Roles and Responsibilities
The NHG Research and Development Office (RDO)
and the Domain Specific Review Boards (DSRB) are
proud to announce the launch of the B2BResearch Online
Application & Review System - a paperless ethics
application and review system.
By 1st February 2008, this user-friendly system will be in placed
to allow researchers to submit their research protocols ONLINE for ethics review.

2. Overview of CRC’s Roles and Responsibilities
Primarily responsible for managing all aspects of the research
Possess an in-depth knowledge of protocol requirements and good clinical practice
A liaison between the investigators, primary care providers, the DSRB, and the sponsor
Screen, enroll and follow study participants together with Investigator
Ensure protocol compliance and close monitoring of participants while in study
Responsible for all data and source documentation, safety reporting, and maintenance of investigator files.

3. CRC’s Roles and Responsibilities
Develop Enrollment Plan & Follow-Up Mechanisms
Begin by reviewing with the Principal Investigator the Inclusion/Exclusion criteria, overall structure and requirements of the protocol
Develop follow-up worksheets
Together with the PI, determine who will be responsible for recruiting potential participants, taking informed consent, checking I/E criteria, performing screening examinations, and enrolling eligible participants into study
During Enrollment, ensure the following:
I/E criteria for each participant have been properly reviewed by designated study team member
Source documents in medical records confirm study eligibility
Participants adequately informed about the study, responsibilities, and follow-up procedures
IRB-approved informed consent form is signed before participant is screened and enrolled
Protocol exemptions and deviations, if any, are documented

4. CRC’s Roles and Responsibilities
During Follow-Up period, ensure the following:
Participant adheres to protocol requirements and Follow-up Visits are scheduled
Participant’s response to therapy and adverse events are assessed and documented
Laboratory data is reviewed and abnormal values communicated to Investigator
Compliance to medication and visits documented
Study drug administered and accounted in drug accountability log
Maintain Proper Study Documentation
DSRB Submissions, Protocol Revisions, and Renewals are prepared as needed
Case Report Forms are completely on time and accurately
Source documentation such as clinic chart visit notes, lab data, and procedure reports that support CRF entries are maintained
UPIRTSO, Protocol Deviations, Non-Compliance are reported to DSRB on time
Investigator File is created before the start of the study, and maintained throughout the study period

5. Useful Templates
 Resource  Research SOPs  Templates
Investigator File Contents Template
Subject Screening & Enrollment Log
Study Responsibility Log
Subject Visit Schedule Log
Protocol Deviation Tracking Log
Specimen Log
Drug Accountability Log
UPIRTSO and SAE Tracking Log
Past issues of Chicken Soup may be found under Resource  Chicken Soup for the Busy Coordinator

6. For Feedback or Suggestions
References
NHG PCR SOP 501-A02 “Responsibilities of the Research Team”
Investigator Manual: All That An Investigator Needs to Know: Section 10.0 – Responsibilities of Investigator
Singapore Guideline For Good Clinical Practice: Section 4 - Investigator
For Feedback or Suggestions
Clinical Research Coordinator Society
c/o Research & Development Office
6 Commonwealth Lane
#04-01/02 GMTI Building
Singapore