FDA Form 3455 (Disclosure: Financial Interests and Arrangements of Clinical Investigators)

FDA Form 3455, titled “Disclosure: Financial Interests and Arrangements of Clinical Investigators,” is the form a marketing-application sponsor files with FDA under 21 CFR Part 54 when a clinical investigator on a covered study has a financial interest or arrangement that must be reported. It is the disclosure counterpart to FDA Form 3454, the certification form used when the sponsor’s review finds nothing reportable. Every covered study’s investigators fall into one path or the other — there is no third option and no way to omit the screening itself.

Why 21 CFR Part 54 requires this

Part 54 addresses a specific bias risk: an investigator’s financial stake in a study’s outcome — equity in the sponsor, a royalty or proprietary interest in the tested product, or compensation structured to depend on results — can affect how a study is conducted, reported, or interpreted, even unintentionally. FDA does not prohibit these arrangements outright. Instead it requires sponsors to identify them for every covered clinical study (a human study submitted in a marketing application that the applicant or FDA relies on to establish effectiveness, or one where a single investigator’s contribution is significant to a safety finding, per 21 CFR 54.2(e)) and either certify their absence or disclose them. Form 3455 is the disclosure route.

What counts as a disclosable financial interest

Under 21 CFR 54.2 and 54.4, a sponsor must screen every investigator and subinvestigator on a covered study — plus each one’s spouse and dependent children — for:

• Compensation tied to study outcome — a payment arrangement, such as a bonus for a favorable result, where the amount or timing could be influenced by how the study comes out.
• Significant equity interest — an ownership stake in the sponsor whose value cannot be readily determined by public prices, or, for a publicly traded sponsor, an equity interest exceeding $50,000 (21 CFR 54.2(b)) held during the study and for one year after its completion.
• Proprietary interest in the tested product — a patent, trademark, copyright, or licensing agreement the investigator holds in the product under study.
• Significant payments of other sorts — payments from the sponsor to the investigator or institution, beyond the direct costs of running the study, totaling more than $25,000 in aggregate during the disclosure period (21 CFR 54.2(f)) — for example a consulting fee, honoraria, or equipment grant.

If the review turns up any one of these for any covered individual, that individual cannot be certified clean on Form 3454 — Form 3455 is required instead.

What Form 3455 must actually disclose

Unlike Form 3454, which is a short certification statement, Form 3455 requires substantive content. Per 21 CFR 54.4(a)(3), the sponsor must disclose, completely and accurately, for each affected investigator:

• The nature of the financial interest or arrangement — what kind it is and how it arose.
• Its approximate value, where a value applies (e.g. the dollar amount of an equity stake or aggregate payments), or, for compensation tied to outcome, a description of how the arrangement works.
• What steps, if any, were taken to minimize the potential for the interest to bias the study’s design, conduct, or reporting — for example, blinding, an independent data-monitoring committee, or excluding the investigator from data analysis.

FDA reviewers weigh this disclosure alongside the study’s results; a disclosed interest does not automatically disqualify the data, but it is a factor FDA can take into account, and the agency can request further information or, in some circumstances, additional analyses to evaluate the interest’s possible effect.

3455 vs. 3454: which form applies

The distinction is entirely about what the sponsor’s inquiry finds, not about the type of study or product:

• Form 3454 (certification) — filed when no investigator on the covered study has any of the interests above. A short statement, dated and signed by the applicant’s chief financial officer or other responsible corporate official, that the inquiry was made and came back clean.
• Form 3455 (disclosure) — filed for the specific investigator(s) whose interests were found reportable. It carries the substantive content described above, not just a signature.

A single marketing application is not necessarily all-or-nothing: a sponsor can file Form 3454 for most of a study’s investigators while filing Form 3455 for the one or two whose situations differ, if that is what the underlying facts show.

When it is filed

Form 3455, like Form 3454, is submitted with the marketing application the covered study supports — an NDA, ANDA, or BLA reviewed by CDER/CBER (see FDA Form 356h, the cover form for those applications), or the analogous device pathways (a PMA, and in some cases a 510(k)) reviewed by CDRH. It is not part of trial start-up paperwork: FDA Form 1572 (the Statement of Investigator, signed per investigator when a trial opens under an IND) establishes who is running the trial and under what protocol, well before FDA or the sponsor knows whether a marketing application — and therefore a Part 54 financial-disclosure filing — will ever follow.

Related CASRAI terms

• FDA Form 3454 (Certification: Financial Interests and Arrangements of Clinical Investigators) — the counterpart form, filed when no disclosable interest exists.
• FDA Form 356h — the cover form for the NDA/ANDA/BLA application that Form 3455 is typically submitted alongside.
• FDA Form 1572 (Statement of Investigator) — a separate, earlier trial start-up certification, unrelated to the Part 54 financial-interest screening.
• FDA Form 483 — an inspectional-observations form, unrelated to the financial-disclosure process.