Printer-friendly version
A participating investigator shall maintain the following accurate, complete and current records relating to the investigator’s participation in an investigation. The sponsor-investigator must maintain records relating to the shipment, receipt, use (including adverse effects), and disposition of the device.
An investigator or sponsor may withdraw from the responsibility to maintain records for the period required in 21 CFR 812.140(d) and transfer custody of the records to any other person who will accept responsibility for them under 21 CFR 812.140, including the requirements of 21 CFR 812.145 (21 CFR 812.140(e)). Notice of this transfer shall be given to the FDA not later than 10 working days after transfer occurs.