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IDE Investigator Responsibilities - Documentation


Records


The investigator must maintain accurate and complete records relating to the investigation. These records include:

  • all correspondence including required reports,
  • 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,
  • any other records that FDA requires to be maintained by regulation or by specific requirement for a category of investigation or a particular investigation.

See Records for additional information on recordkeeping requirements.


Investigator Reports


The investigator must provide the following reports in a timely manner to the sponsor and/or the IRB.

  • Unanticipated Adverse Device Effects
  • Withdrawal of IRB Approval
  • Progress Reports
  • Deviations from the Investigational Plan
  • Informed Consent
  • Final Report
  • Other Reports