Reporting Requirements

Are there specific reporting requirements once my IRB Protocol has been approved?  Yes.  You must inform the IRB of any complaints from human subjects and any adverse events. Principal Investigators must also file a Continuing Review form at least every 365 days. Failure to return the Continuing Review form by the deadline results in the immediate suspension of the protocol. Such suspension requires that all activity on the project stop, not just the enrollment of subjects and collection of data. Research activities may not resume until you receive a new IRB approval letter.