IDE Records: Investigator Records

Investigator Records for Significant Risk Device Studies

These records include:

• all correspondence including required reports
• type and quantity of device
• date of receipt
• batch number or code
• name of person that received, used, or disposed of each device
• why and how many units of the device have been returned to the sponsor, repaired, or otherwise disposed of


• records of receipt, use, or disposition of the investigational device
• signed and dated consent forms
• condition of each subject upon entering the study
• relevant previous medical history
• record of the exposure to the investigational device, including the date and time of each use and any other therapy
• observations of adverse device effects
• medical records (physician and nurse progress notes, hospital charts, etc.)
• results of all diagnostic tests
• case report forms
• any other supporting data


• records of each subject's case history and exposure to the device which must include:
• 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.

Investigator Records for Nonsignificant Risk Device Studies

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

Case histories include case report forms and supporting data, including signed and dated consent forms and medical records, including progress notes of the physician, the individual’s hospital chart(s), and the nurses’ notes.

Records must include documents demonstrating informed consent and, for any use of a device the investigator without informed consent, any written concurrence of a licensed physician and a brief description of the circumstances justifying the failure to obtain informed consent.

The case history of each individual must document that informed consent was obtained prior to participation in the study.