CFR section

21 CFR 312.64(d): Investigator reports

PART 312-INVESTIGATIONAL NEW DRUG APPLICATION · Subpart D-Responsibilities of Sponsors and Investigators

Key facts

Citation 21 CFR 312.64(d)
Section Investigator reports
Part PART 312-INVESTIGATIONAL NEW DRUG APPLICATION
Subpart Subpart D-Responsibilities of Sponsors and Investigators
Subchapter 21 CFR D Drugs Human
Product types cited Drugs, General
Regulation text (excerpt) (d) Financial disclosure reports. The clinical investigator shall provide the sponsor with sufficient accurate financial information to allow an applicant to submit complete and accurate certification or disclosure statements as required under part 54 of this chapter. The clinical investigator shall promptly update this information if any relevant changes occur during the course of the investigation and for 1 year following the completion of the study.

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