How long does the FDA require the Investigator to retain documents on a clinical study with an Investigational New Drug (IND)?
The documents should be retained:
2 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 2 years after the investigation is discontinued and FDA is notified.
NOTE: UC or UCLA retention policies may require retention for a longer period of time.
