May 30, 2012
The IRB was inspected by the FDA May 14 through May 18. The inspector informed us that she discovered no actionable items. This is our third FDA inspection in the last decade with no findings. We feel this demonstrates the University's strong commitment to protect the rights and welfare of research participants. Our board members and the IRB staff do an excellent job, and we will continue to work to improve so we have the same result when the FDA returns in five years.
Review a signed memorandum regarding the IRB's FDA inspection history.