Get Fda Form 3455

applicants may submit a single FORM FDA 3455, with attachments clearly identifying all clinical investigators with information to disclose and, for each investigator, identifying the study, the specific details of their financial interests and arrangements and the steps taken to minimize the potential for bias.

4.1 Each clinical investigator /sub-Investigator must submit either a completed financial disclosure statement attesting to the absence of financial interests/arrangement or disclose any financial interests/arrangements and steps taken to minimize the potential for bias.

Form FDA 3454. Certification: Financial Interests and Arrangements of Clinical Investigators. Form FDA 3455. Disclosure: Financial Interests and Arrangements of Clinical Investigators.

Complete form 3454 if none of the investigators have any FDA required disclosures. Complete form 3455 if any clinical investigator has a financial disclosure that is significant.

6. Q: Who, specifically, is responsible for signing the financial certification/disclosure forms? A: The forms are to be signed and dated by the chief financial officer or other responsible corporate official or representative of the applicant.

To ensure the reliability of the data, the financial interests and arrangements of clinical investigators must be disclosed to FDA.

Complete form 3454 if none of the investigators have any FDA required disclosures. Complete form 3455 if any clinical investigator has a financial disclosure that is significant.

Financial disclosure is the submission of information concerning compensation to, and financial interests and arrangements of, any clinical investigator conducting clinical studies.