All studies approved or determined exempt by the IRB have reporting requirements over the course of study. For a summary of these requirements, see the IRB webpage on after approval activities. For a more detailed description, see the IRB Investigator Manual.
Note: Typically, if you are notifying a sponsor or the FDA about a protocol amendment or a reportable event, you must also report the same to the IRB. New protocols and a change in protocol must be submitted to and approved by the IRB before the research activities can begin. Unintended or unexpected events or protocol deviations often need reported to the IRB as "reportable new information" within 5 business days.
Research Topic