Presentation on theme: "The Clinical Research Coordinators Roles and Responsibilities Chicken Soup for the Busy Coordinator (June 2010)"— Presentation transcript:
The Clinical Research Coordinators Roles and Responsibilities Chicken Soup for the Busy Coordinator (June 2010)
Overview of CRCs 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.
1.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 2.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 CRCs Roles and Responsibilities
3.During Follow-Up period, ensure the following: Participant adheres to protocol requirements and Follow-up Visits are scheduled Participants 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 4.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 CRCs Roles and Responsibilities
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
References Clinical Research Coordinator Society c/o Research & Development Office 6 Commonwealth Lane #04-01/02 GMTI Building Singapore Clinical Research Coordinator Society c/o Research & Development Office 6 Commonwealth Lane #04-01/02 GMTI Building Singapore For Feedback or Suggestions 1. 1.NHG PCR SOP 501-A02 Responsibilities of the Research Team 2. 2.Investigator Manual: All That An Investigator Needs to Know: Section 10.0 – Responsibilities of Investigator 3. 3.Singapore Guideline For Good Clinical Practice: Section 4 - Investigator