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A clinical investigator shall disclose to the sponsor sufficient accurate financial information to allow the applicant to submit complete and accurate certification or disclosure statements. The investigator shall promptly update any changes to financial disclosure information and report it to the FDA during the investigation and for 1 year following completion of the study.
The sponsor-investigator is responsible for maintaining the following records during and for 2 years after completion or termination of the investigation or 2 years after the records are no longer needed to support a premarket approval application or a notice of completion of a product development protocol. 21 CFR 812.140d. The sponsor-investigator must make these available to FDA inspectors at their request.