Investigators must disclose their and their immediate family members significant obligations, significant financial interests, and sponsored travel that is related to their institutional ...
FDA and the University IRB recognize there may be circumstances for a health care provider to use an unapproved or investigational device to save the life of a patient or to help a patient suffering ...
For research involving medical devices, the University IRB will comply with the requirements set forth in 21 CFR Part 812. Per FDA regulations at 21 CFR 812, FDA’s regulations specify the ...
The U.S. Food and Drug Administration has released draft guidance for clinical trial investigators outlining their safety reporting duties for investigational drugs and devices. “Most of the ...
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