For drugs, according to 21 CFR 312.62(c), an investigator shall retain records required to be maintained under the part 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 applications is not approved for such indication, until two years after the investigation is discontinued and FDA is notified. For devices, according to 21 CFR 812.140(d), an investigator or sponsor shall maintain the records required by this subpart during the investigation and for a period of two years after the latter of the following two dates: the date on which the investigation is terminated or completed, or the date that the records are no longer required for purposes of supporting a premarket approval application or a notice of completion of a product development protocol. Study Sponsors may have additional document retaining provisions stipulated in the Contract.
Research Topic