When a clinical study ends, advise Office of Research and Development of the location at which clinical study records and data will be stored. Refer to the award document (clinical study agreement) to determine Sponsor requirements for record retention. At minimum, FDA regulations (found at 21 CFR Section 312.62) state that an investigator shall retain clinical trial records for a period of two years following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or if the application is not approved for such indication, until two years after the investigation is discontinued and FDA is notified. In order to comply with these regulations, the study Sponsor usually notifies the Principal Investigator when such an event occurs, and requires that the Principal Investigator or the University notify the Sponsor prior to destroying any study records. Copies of any such notifications should be provided to Office of Research and Development for the official agreement file. |
