All studies that were previously approved by expedited or full board review must be inactivated upon completion of the study and records stored by the investigator for at least 3 years (45 CFR #46.115(b); Investigator Responsibilities). Inactivation should be completed when enrollment is closed, data is no longer being collected, and analysis is complete or involves only de-identified data. Note that if the study is Federally funded or if you are the lead site on a multi-center trial with active sites, you must keep the protocol open and submit continuing reviews at least annually per your approval letter. Please submit the inactivation materials at least 30 days prior to expiration to email@example.com per the submission instructions.
Also attach, if applicable: