Presentation on theme: "Chicken Soup for the Busy Coordinator"— Presentation transcript:
1Chicken Soup for the Busy Coordinator (June 2010)The Clinical Research Coordinator’s Roles and ResponsibilitiesThe NHG Research and Development Office (RDO)and the Domain Specific Review Boards (DSRB) areproud to announce the launch of the B2BResearch OnlineApplication & Review System - a paperless ethicsapplication and review system.By 1st February 2008, this user-friendly system will be in placedto allow researchers to submit their research protocols ONLINE for ethics review.
2Overview of CRC’s Roles and Responsibilities Primarily responsible for managing all aspects of the researchPossess an in-depth knowledge of protocol requirements and good clinical practiceA liaison between the investigators, primary care providers, the DSRB, and the sponsorScreen, enroll and follow study participants together with InvestigatorEnsure protocol compliance and close monitoring of participants while in studyResponsible for all data and source documentation, safety reporting, and maintenance of investigator files.
3CRC’s Roles and Responsibilities Develop Enrollment Plan & Follow-Up MechanismsBegin by reviewing with the Principal Investigator the Inclusion/Exclusion criteria, overall structure and requirements of the protocolDevelop follow-up worksheetsTogether 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 studyDuring Enrollment, ensure the following:I/E criteria for each participant have been properly reviewed by designated study team memberSource documents in medical records confirm study eligibilityParticipants adequately informed about the study, responsibilities, and follow-up proceduresIRB-approved informed consent form is signed before participant is screened and enrolledProtocol exemptions and deviations, if any, are documented
4CRC’s Roles and Responsibilities During Follow-Up period, ensure the following:Participant adheres to protocol requirements and Follow-up Visits are scheduledParticipant’s response to therapy and adverse events are assessed and documentedLaboratory data is reviewed and abnormal values communicated to InvestigatorCompliance to medication and visits documentedStudy drug administered and accounted in drug accountability logMaintain Proper Study DocumentationDSRB Submissions, Protocol Revisions, and Renewals are prepared as neededCase Report Forms are completely on time and accuratelySource documentation such as clinic chart visit notes, lab data, and procedure reports that support CRF entries are maintainedUPIRTSO, Protocol Deviations, Non-Compliance are reported to DSRB on timeInvestigator File is created before the start of the study, and maintained throughout the study period
5Useful Templates Resource Research SOPs TemplatesInvestigator File Contents TemplateSubject Screening & Enrollment LogStudy Responsibility LogSubject Visit Schedule LogProtocol Deviation Tracking LogSpecimen LogDrug Accountability LogUPIRTSO and SAE Tracking LogPast issues of Chicken Soup may be found under Resource Chicken Soup for the Busy Coordinator
6For Feedback or Suggestions ReferencesNHG PCR SOP 501-A02 “Responsibilities of the Research Team”Investigator Manual: All That An Investigator Needs to Know: Section 10.0 – Responsibilities of InvestigatorSingapore Guideline For Good Clinical Practice: Section 4 - InvestigatorFor Feedback or SuggestionsClinical Research Coordinator Societyc/o Research & Development Office6 Commonwealth Lane#04-01/02 GMTI BuildingSingapore