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Form FDA 3454, or the Financial Certification or Disclosure Statement, is used to submit information regarding clinical investigators who participated in the clinical studies. If no clinical studies were performed, simply state: ?no clinical studies were performed to test this device.?
When new investigators are assigned to a clinical investigation under an investigational new drug application (IND), the sponsor completes and signs a Form 1572 before allowing the investigator to get involved in the clinical investigation.
The FDA Form 1571 or '1571' is the IND application cover page and it must accompany the initial IND submission and any amendments, IND safety reports, annual reports or general correspondence the sponsor submits to the FDA about the IND. The 1571 is a contractual agreement between the sponsor and the FDA.
TTU OP 70.37 asks all employees and other individuals planning to act as investigators, including their spouses and dependent relatives or household members, to disclose: 1) any significant business or financial interest (SFI) that would reasonably appear to be related to the investigator's institutional ... What is an Annual Financial Interest Disclosure? | Research Home ttu.edu ? faculty ? stories ? June ? fina... ttu.edu ? faculty ? stories ? June ? fina...
§ 54.4 Certification and disclosure requirements. The applicant is required to submit for each clinical investigator who participates in a covered study, either a certification that none of the financial arrangements described in § 54.2 exist, or disclose the nature of those arrangements to the agency.