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)

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)