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.
Note: This retention schedule refers to data in any format that it can exist in. To determine the retention of objects that are not expressions of information and are instead actual research products (such as cell lines, biological samples collected for research purposes, synthetic compounds, and organisms) refer to any relevant regulations, laws, or instructions from funding sources.
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