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