2. 1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you press enter.

3. FDA INSPECTIONS of institutional review boards Developed by: U-MIC University of Michigan IRB Collaborative

4. FDA inspections 3 Developed by: U-MIC Part 50: protection of human subjects Part 56: IRBs Part 312: INDs Part 812: IDEs 21 CFR Operations Manual (HRPP) policies basis for procedures periodic, scheduled FDA inspections FDA regulations IRB procedures

5. FDA inspections 4 Developed by: U-MIC before the inspection FDA schedules a site visit issues a Form FDA 482 interviews IRB and institutional representatives policies procedures tracks FDA-regulated studies examines procedures and membership rosters

6. FDA inspections 5 Developed by: U-MIC during the inspection FDA reviews and copies records of IRB membership procedures and guidelines minutes of IRB meetings study-related documents  from researcher to IRB  from IRB to researcher other materials

7. FDA inspections 6 Developed by: U-MIC at the end of the inspection FDA conducts exit interview issues Form FDA 483 (if deficiencies have been observed) o IRB may respond  verbally  in writing (within 15 days) o U-M always responds in writing to 483 observations

8. FDA inspections 7 Developed by: U-MIC after the inspection FDA issues Establishment Inspection Report (EIR) evaluates EIR, 483 (if issued), and IRB response at Headquarters issues one of the following: o letter identifying no significant deviations o informational or untitled letter identifying deviations for which voluntary corrective action is sufficient o Warning Letter identifying serious deviations  prompt correction by IRB  written response to FDA may require IRB to respond to inspection letter within a specified period present corrective action plan may schedule re-inspection

9. FDA inspections 8 Developed by: U-MIC after the inspection FDA may take other administrative actions withhold approval of new studies direct that no new subjects take part in ongoing studies terminate ongoing studies report deficiencies to state, federal, or other regulatory agencies Refusal or repeated failure to comply with FDA regulations may result in proceedings to disqualify IRB or institution.

10. FDA inspections 9 Developed by: U-MIC FDA inspections of institutional review boards

11. THANK YOU. Brian Seabolt Claudia Krcmarik IRBMED 10 Developed by: U-MIC