How to Complete FDA Form 3454 or 3455: Reportable Interests and Submission

FDA Form 3454 and 3455 work as a pair for clinical investigator financial disclosure: file Form 3454 to certify that your covered investigators have no reportable financial ties to the sponsor, and file Form 3455 to disclose the details when an investigator does. Every marketing application that relies on clinical data, whether for a drug, biologic, or medical device, must include one form or the other for each investigator who participated in a covered study.1eCFR. 21 CFR 54.4 – Certification and Disclosure Requirements Both forms are PDFs on FDA’s clinical trial forms page.2Food and Drug Administration. Clinical Trial Forms

Which Studies Actually Require the Forms

Not every study triggers the paperwork. The regulation defines a “covered clinical study” as one submitted in a marketing application that the applicant or FDA relies on to establish effectiveness, or one where a single investigator makes a significant contribution to demonstrating safety. Phase 1 tolerance studies, most pharmacokinetic studies, large open-label multi-site safety studies, and treatment or parallel-track protocols generally fall outside that definition. If you are unsure about a particular study, FDA allows applicants to consult the agency before filing.3eCFR. 21 CFR 54.2 – Definitions

Full-time and part-time employees of the sponsor are exempt from the certification and disclosure requirement, but the applicant must still identify them on the required list of investigators who conducted covered studies.1eCFR. 21 CFR 54.4 – Certification and Disclosure Requirements

The Four Financial Interests You Have To Report

Before you can choose between the two forms, you have to know what counts as a reportable interest. Four categories matter, each defined at 21 CFR 54.2:3eCFR. 21 CFR 54.2 – Definitions

  • Outcome-affected compensation. Any arrangement where the investigator’s pay could change based on the study’s result, such as royalties or stock options tied to product approval.4Food and Drug Administration. Financial Disclosures by Clinical Investigators
  • Significant equity interest. Any ownership stake in a publicly traded sponsor exceeding $50,000 during the study and for one year after, or any equity in a non-publicly traded sponsor regardless of value.
  • Proprietary interest. A patent, trademark, copyright, or licensing agreement related to the tested product. No dollar threshold applies; any proprietary interest triggers disclosure.
  • Significant payments of other sorts. Payments from the sponsor to the investigator or institution exceeding $25,000, not counting the cost of conducting the study itself. This includes research grants, equipment, consulting retainers, and honoraria.

The reporting window covers the entire time the investigator is conducting the study, plus one year after the study ends. The $50,000 and $25,000 figures are set by regulation and are not adjusted annually.

How To Complete Form 3454

Form 3454 is the short form. You use it when every investigator on your list is clean across all four categories above. The form is a single page with three mutually exclusive certification boxes plus space for the names of investigators it covers.5Food and Drug Administration. Certification: Financial Interests and Arrangements of Clinical Investigators

Pick The Right Certification Box

The three options reflect different relationships between the filer and the study.

Box 1 is the sponsor certification. Check it if you sponsored the studies. You are certifying that you entered into no outcome-affected compensation arrangements with the listed investigators, that none disclosed a proprietary interest or significant equity stake, and that none received significant payments of other sorts.

Box 2 is the applicant certification for filers who are not the sponsor. You certify the same clean picture based on information you obtained from the sponsor or the investigators themselves.

Box 3 is the due diligence certification. Check it only when you tried to obtain the financial information and could not, and attach an explanation of why the information was unavailable. Box 3 is a fallback, not a convenience. FDA expects applicants to collect financial data proactively, and leaning on it without a credible explanation will draw scrutiny.

List The Investigators

Enter the names of all investigators covered by the certification on the form or on an attached list. If the Form 3454 does not cover every covered clinical study in the application (because some investigators have disclosable interests), you must also identify which specific studies this certification covers.1eCFR. 21 CFR 54.4 – Certification and Disclosure Requirements A chief financial officer or other responsible corporate official signs and dates the form.

How To Complete Form 3455

Form 3455 is the detailed form. File it for any investigator with at least one reportable financial interest. The form identifies the investigator by name and uses checkboxes matched to the four disclosure categories: outcome-affected compensation, significant equity, proprietary interest, and significant payments.6Food and Drug Administration. Disclosure: Financial Interests and Arrangements of Clinical Investigators

What You Have To Attach

Checkboxes alone are not enough. You must attach a narrative covering two things: the details of the financial arrangement, and the steps taken to minimize potential bias in the study.6Food and Drug Administration. Disclosure: Financial Interests and Arrangements of Clinical Investigators The bias-mitigation piece is where most of the work sits. Reviewers want concrete safeguards: whether the trial was blinded, whether the investigator was masked to treatment assignments, or whether an independent data monitoring committee reviewed results. Vague assurances do not satisfy the requirement.

One Form Or Several

You can submit a single Form 3455 with attachments covering multiple investigators, provided each investigator is clearly identified in the supporting documentation. For large multi-site trials this is more practical than filing a separate form per person. What matters is that each investigator’s specific interests and the corresponding safeguards are individually identifiable.

When And How To Submit

Financial disclosure forms are filed with the marketing application (NDA, BLA, PMA, or 510(k)), not during the investigational phase. The obligation attaches when “covered clinical studies are submitted to FDA in support of product marketing.”4Food and Drug Administration. Financial Disclosures by Clinical Investigators The applicant must also include a complete list of all clinical investigators who conducted covered studies, noting which are full-time or part-time sponsor employees.1eCFR. 21 CFR 54.4 – Certification and Disclosure Requirements

Waiting until the application stage to start collecting financial data is a common mistake. By then, investigators may have changed institutions or become hard to reach, and Box 3 becomes the only option left.

If A Form Is Missing

FDA treats a missing Form 3454 or 3455 as a deficiency that can trigger a Refuse to File action. Agency review practice is to notify the applicant of this kind of correctable deficiency with time to fix it before the filing deadline. If the missing disclosure is one of many deficiencies, FDA may issue a Refuse to File without offering a correction window.7Food and Drug Administration. Good Review Practice – Refuse to File A single missing form is usually fixable; a pattern of incomplete paperwork across multiple investigators signals a problem reviewers notice.

What FDA Does With A Disclosure

Disclosure does not automatically disqualify a study or an investigator. FDA weighs the disclosed interests against the study’s design, conduct, and results to decide whether the financial ties raise a serious question about data integrity. If they do, the agency has four options:8eCFR. 21 CFR 54.5 – Agency Evaluation of Financial Interests

  • Audit the clinical data from that site or investigator.
  • Ask the applicant to reanalyze the study without the flagged investigator’s data.
  • Require additional independent studies to confirm the questioned results.
  • Decline to rely on the covered study as data supporting approval.

A well-designed study with strong safeguards can survive an investigator’s financial disclosure. Blinding, independent monitoring, and pre-specified statistical analysis plans all work in the applicant’s favor. What makes FDA uncomfortable is a disclosed interest paired with a study design that gave the investigator discretion over subjective endpoints or unblinded data.

Record Retention

Keep the financial disclosure records for each clinical investigator for at least two years after FDA approves the application.9eCFR. 21 CFR 54.6 – Recordkeeping and Record Retention This covers records documenting financial arrangements, equity interests, proprietary interests, and significant payments. The two-year clock is tied specifically to the approval date.