Frequently Asked Questions

What type of records does the FDA require the investigator to retain for studies involving Non-Significant Risk devices?

Clinical investigators must maintain the records of each subject’s case history and exposure to the device. Case histories include:

• all correspondence, including required reports (e.g. progress and final reports, reports of adverse events and protocol deviations, etc. )
• case report forms and supporting data
• signed and dated consent forms and research record notations demonstrating that informed consent was obtained prior to participation in study
• medical records (including progress notes of the physician, hospital chart(s), and nurses’ notes)