IDE Investigator Responsibilities – Nonsignificant Risk Device Studies

Responsibilities of Investigators for Nonsignificant Risk Device Studies

Informed Consent

An investigator is responsible for obtaining informed consent under 21 CFR Part 50.

Records

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.

Reports

Clinical investigators must make the following required reports:

• Unanticipated Adverse Device Effects
• Withdrawal of IRB Approval
• Informed consent
• Other reports requested by a reviewing IRB or FDA

Financial Disclosure

If the data in a nonsignificant risk device study is submitted in a marketing application, then 21 CFR 54, Financial Disclosure, applies. The clinical investigator must disclose to the sponsor sufficient accurate financial information to allow the IDE applicant (or sponsor) to submit certification or disclosure of financial interests. The investigator must update the information if any relevant changes occur during the course of the investigation and for one year following completion of the study.