1. Monitoring IRB Monitoring of Clinical Trials

2. Types of Monitoring Internally Internally Externally Externally

3. Which Protocols are Monitored? All protocols reviewed by the IRB are subject to regulatory monitoring by IRB personnel; 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; A random list is generated yearly by the IRB Information Systems Specialist of active protocols for monitoring; In addition, protocols are monitored for- cause. In addition, protocols are monitored for- cause.

4. Types of Studies Selected Investigator-initiated studies; Investigator-initiated studies; Investigator-held IND/IDE studies; Investigator-held IND/IDE studies; High-risk studies designated by the IRB; High-risk studies designated by the IRB; At the request of the IRB; At the request of the IRB; For cause; For cause; Studies conducted by investigators with prior 483 Inspectional Observations or warning letters from the FDA; 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; Studies with a large number of SAEs or protocol deviations reported; High enrollment studies; High enrollment studies; Outside monitoring reports from sponsors received by the OIRB indicating deficiencies; Outside monitoring reports from sponsors received by the OIRB indicating deficiencies; At the request of and in conjunction with the UAB Research Compliance Office. At the request of and in conjunction with the UAB Research Compliance Office.

5. Investigator Responsibilities Responds promptly to requests by the OIRB for arranging audit of the regulatory files; Responds promptly to requests by the OIRB for arranging audit of the regulatory files; Provides a quiet area for the records review; Provides a quiet area for the records review; Is available, along with study coordinator, during the review to answer questions; Is available, along with study coordinator, during the review to answer questions; Responds promptly, in writing, to requests by the OIRB monitor; Responds promptly, in writing, to requests by the OIRB monitor; Submits a corrective action plan, in writing, within 30 days, if requested. Submits a corrective action plan, in writing, within 30 days, if requested.

6. OIRB Monitor Responsibilities Schedules appointment for regulatory monitoring with the investigator and study coordinator usually 2 to 4 days in advance of visit; 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; 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; Meets with the study coordinator and principal investigator, if needed;

7. OIRB Monitor Responsibilities Completes monitoring report forms within 2 weeks of audit; Completes monitoring report forms within 2 weeks of audit; Sends copy of the report to the PI; Sends copy of the report to the PI; Schedules the report for the next convened IRB meeting; Schedules the report for the next convened IRB meeting; Re-audits in 6 months if audit reveals deficiencies that are unacceptable. Re-audits in 6 months if audit reveals deficiencies that are unacceptable.

8. What is Reviewed and Verified? Study protocol approved; Study protocol approved; Continuing reviews submitted prior to expiration of approval; Continuing reviews submitted prior to expiration of approval; Screening and enrollment logs accurate and up to date; Screening and enrollment logs accurate and up to date; IRB approval obtained prior to participant enrollment; IRB approval obtained prior to participant enrollment; Valid informed consent documents were used; Valid informed consent documents were used; Original signed informed consent documents appropriately executed; Original signed informed consent documents appropriately executed; Addendum informed consent documents signed, if applicable; Addendum informed consent documents signed, if applicable; Adherence to study protocol; Adherence to study protocol;

9. Modifications to the protocol and informed consent document submitted to the IRB and approved prior to initiation; Modifications to the protocol and informed consent document submitted to the IRB and approved prior to initiation; Accurate, complete and current records being maintained; 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; 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; 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; Principal investigator carrying out the agreed upon activities and not delegating them to other staff not previously identified; Records maintained appropriately. Records maintained appropriately. What is Reviewed and Verified?

10. IRB Responsibilities Reviews monitoring reports at a convened meeting; Reviews monitoring reports at a convened meeting; Makes a determination to accept the report; Makes a determination to accept the report; Takes action, if indicated and determined to be necessary, based on the report. Takes action, if indicated and determined to be necessary, based on the report.

11. Questions?