What type of records does the FDA require the investigator to retain for studies involving Significant Risk devices?
The investigator must maintain accurate and complete records relating to the investigation. These records include:
all correspondence with the sponsor, other PIs, the IRB, FDA and other regulatory correspondence, etc.
records of receipt, use, or disposition of the investigational device
records of each subject's case history and exposure to the device
the protocol and documentation (date and reason) for each deviation from the protocol (if any)
any other records that FDA requires to be maintained by regulation or by specific requirement for a category of investigation or a particular investigation
