Research documentation and raw data (including personal identifiers) obtained in the course of a FDA-regulated study to develop a drug. May include Investigators' Notebooks (laboratory notes documenting the results of experiments), patient files, case files, and other records of the dates, quantity and use of a drug on subjects. Also includes all correspondence with other investigators, the IRB, the sponsor, a monitor, or FDA, including required reports.
Official Copy: Principal Investigator
Retention: 30 Years after close of study if FDA status is unknown; or 2 years following the date a marketing application is approved by the FDA; or, for drug studies where no application is to be filed or if the application is not approved for such indication, retain all records for 2 years after the investigation is discontinued and FDA is notified.
Disposition Method: Shred or Delete