Requirements

Signed and dated FDA Financial Disclosures for all clinical investigators listed on the form FDA 1572 (drug) or IRB application (device).

QIU Tips / Additional Information

If FDA Financial Disclosures are filed separately and/or electronically, include a signed and dated note indicating the location.

Any applicant (usually a pharmaceutical/device company) who submits a marketing application for a human drug, biological product, or device is required to submit a completed Form FDA 3455 to the FDA for each clinical investigator who participates in a covered study. This form attests to the absence of financial interests, or discloses the nature of any financial arrangements.

Everyone listed on the Form FDA 1572 (drug) or IRB application (device) shall provide to the sponsor sufficient accurate financial information on Form FDA 3455. The investigator should promptly update this information if any relevant changes occur in the course of the study, or for one year following completion of the study.

Some studies may also require a Financial Disclosure form. Refer to the UCSF Financial Conflicts of Interest in Human-Subjects Research policy for guidance.