ix. Financial disclosure reports 21 CFR 312.57d

Any changes to financial disclosure information must be promptly reported to the FDA during the investigation and for 1 year following completion of the study.

The sponsor-investigator is responsible for maintaining the following records during and for 2 years after the date a marketing application is approved for the drug for the indication for which it is being investigated.  If no application is to be filed or if the application is not approved for such an indication, the sponsor-investigator is responsible for maintaining the following records until 2 years after the investigation is discontinued and FDA is notified [21 CFR 312.62].  The sponsor- investigator must make these available to FDA inspectors at their request.