IDE Sponsor Responsibilities - Investigator Agreements

A sponsor must obtain a signed agreement from each participating investigator that includes:

• the investigator's curriculum vitae,
• a statement of the investigator's relevant experience, including the dates, location, extent, and type of experience, where applicable,
• an explanation of the circumstances that led to termination of a study if the investigator was involved in an investigation or other research that was terminated,
• a statement of the investigator's commitment to:
• conduct the investigation in accordance with the agreement, the investigational plan, the IDE and other applicable FDA regulations, and conditions of approval imposed by the reviewing IRB or FDA,
• supervise all testing of the device involving human subjects. and
• ensure that the requirements for obtaining informed consent are met.


• sufficient accurate financial disclosure information to allow the sponsor to submit a complete and accurate certification or disclosure statement as required under 21 CFR 54, Financial Disclosure by Clinical Investigators. The sponsor shall also obtain a commitment from the clinical investigator to promptly update this information if any relevant changes occur during the course of the investigation and for one year following completion of the study. (The financial certification or disclosure is submitted in the PMA or Premarket Notification 510(k) application. It should not be submitted in the IDE application.)