Status Definition

Revision with Full Committee Review

The Principal Investigator must make the changes requested by the Committee. These changes are generally major and complex. These changes are reviewed by the entire IRB at their next meeting.

If the changes are judged to be responsive to the requests of the Committee, the full Committee will recommend the protocol for approval and an approval letter will be issued.

The protocol is then classified as APPROVED and subjects may be enrolled upon receipt of the approval notice and date stamped consent form.