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MD Anderson Events

Office of Protocol Research (OPR) Brown Bag Session: IRB Policy for Investigators on Reporting Unanticipated Adverse Events for Drugs and Devices

Office of Protocol Research (OPR) Brown Bag Session: IRB Policy for Investigators on Reporting Unanticipated Adverse Events for Drugs and Devices

1.      Purpose of the Presentation? To inform clinical research faculty and staff of the revised IRB policy for Investigators on Reporting Unanticipated Events for Drugs and Devices.

2.      Which regulations or institutional policies are relevant to discussion? 21 CFR 812.150(a) (1) & 21 CFR 812.3 (s)

3.      Who will it impact (eg. researchers, admin staff, sponsors, etc)? All clinical research faculty and staff.

4.      When will the changes be implemented? October 1, 2012.

Date: 9/10/12, 12pm to 1pm
Time: 9/10/12, 12pm to 1pm
Location: AT&T Auditorium, Main Building, Floor 2 (B2.4750)
Format: All Employee Meeting
Contact: Leola Griffin - opreducation@mdanderson.org