Research documentation and raw data (including personal identifiers) obtained in the course of a FDA-regulated study to develop a device. 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 device on subjects. Also includes all correspondence with other investigators, the IRB, the sponsor, a monitor, or FDA, including required reports.
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 the close of the study if FDA status is unknown; or, 2 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, a notice of completion of a product development protocol, a humanitarian device exemption application, a premarket notification submission, or a request for De Novo classification.
Disposition Method: Shred or Delete