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Monitoring IRB Monitoring of Clinical Trials Types of Monitoring Internally Externally Which Protocols are Monitored? All protocols reviewed by the IRB are subject to regulatory monitoring by IRB personnel; A random list is generated yearly by the IRB Information Systems Specialist of active protocols for monitoring; In addition, protocols are monitored for- cause. Types of Studies Selected Investigator-initiated studies; Investigator-held IND/IDE studies; High-risk studies designated by the IRB; At the request of the IRB; For cause; Studies conducted by investigators with prior 483 Inspectional Observations or warning letters from the FDA; Studies with a large number of SAEs or protocol deviations reported; High enrollment studies; Outside monitoring reports from sponsors received by the OIRB indicating deficiencies; At the request of and in conjunction with the UAB Research Compliance Office. Investigator Responsibilities Responds promptly to requests by the OIRB for arranging audit of the regulatory files; Provides a quiet area for the records review; Is available, along with study coordinator, during the review to answer questions; Responds promptly, in writing, to requests by the OIRB monitor; Submits a corrective action plan, in writing, within 30 days, if requested. OIRB Monitor Responsibilities Schedules appointment for regulatory monitoring with the investigator and study coordinator usually 2 to 4 days in advance of visit; Sends follow-up written communication confirming appointment and list of pertinent study materials that should be available for the reviewer as well as any issues that need to be specifically addressed; Meets with the study coordinator and principal investigator, if needed; OIRB Monitor Responsibilities Completes monitoring report forms within 2 weeks of audit; Sends copy of the report to the PI; Schedules the report for the next convened IRB meeting; Re-audits in 6 months if audit reveals deficiencies that are unacceptable. What is Reviewed and Verified? Study protocol approved; Continuing reviews submitted prior to expiration of approval; Screening and enrollment logs accurate and up to date; IRB approval obtained prior to participant enrollment; Valid informed consent documents were used; Original signed informed consent documents appropriately executed; Addendum informed consent documents signed, if applicable; Adherence to study protocol; What is Reviewed and Verified? Modifications to the protocol and informed consent document submitted to the IRB and approved prior to initiation; Accurate, complete and current records being maintained; Timely, accurate, and complete reporting of serious adverse events and protocol deviations to the sponsor and the UAB IRB; Qualified investigators/study personnel conducting study activities; Principal investigator carrying out the agreed upon activities and not delegating them to other staff not previously identified; Records maintained appropriately. IRB Responsibilities Reviews monitoring reports at a convened meeting; Makes a determination to accept the report; Takes action, if indicated and determined to be necessary, based on the report. Questions?
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