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.
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