Common use of Study Documentation Clause in Contracts

Study Documentation. The Principal Investigator and study staff has the responsibility of maintaining a comprehensive and centralized filing system containing all study related documentation. These files must be suitable for inspection by LSO or the FDA at any time, and should consist of the following elements: Patient files, containing the completed medical records, laboratory data, supporting source documentation, and the informed consent; Study files, containing the protocol with all amendments, copies of all regulatory documentation, and all correspondence between the IRB and Sponsor; Drug accountability files, containing a complete account of the receipt and disposition of the drug and device. Records are to be available for two years after marketing application approval, or if the application is not approved or never submitted, two years after the last shipment and delivery of the material and the FDA is so notified. The files should not be destroyed until the official termination letter from the Light Science Oncology.