FDA Form 3454 is the one-page certification a sponsor or applicant files to confirm that the clinical investigators behind a covered study have no reportable financial ties to the sponsor. It travels inside a marketing application for a drug, biologic, or device, and it must cover every investigator who participated in a covered clinical study. To complete it, you vet each investigator’s finances against the thresholds in 21 CFR Part 54, choose one of three certification statements on the form, attach a list of the investigators being certified, and have a responsible corporate official sign and date it. The current version is available on the FDA’s clinical trial forms page at fda.gov.
When to Use Form 3454 Instead of Form 3455
Any applicant whose marketing application relies on clinical studies has to file either Form 3454 or Form 3455 for each clinical investigator, under 21 CFR 54.4. The requirement runs across NDAs, BLAs, PMAs, and 510(k) submissions.1eCFR. 21 CFR 54.4 – Certification and Disclosure Requirements
Form 3454 is the right form when you can certify that a given investigator has no disclosable financial interests. If an investigator does have a reportable interest, that person goes on Form 3455 instead, with full details of the arrangement and the steps taken to minimize potential bias.2eCFR. 21 CFR Part 54 – Financial Disclosure by Clinical Investigators It’s common to file both forms in the same application: 3454 for the clean investigators, 3455 for the ones with something to disclose.
What Counts as a Disclosable Financial Interest
You can’t honestly certify the absence of something until you know what you’re looking for. Part 54 flags four categories that would push an investigator onto Form 3455:
- Compensation arrangements where the investigator’s pay could rise or fall based on the study’s outcome, including finder’s fees and royalty interests.3eCFR. 21 CFR 54.2 – Definitions
- A significant equity interest: any ownership stake or options in a nonpublicly traded sponsor, or equity in a publicly traded sponsor worth more than $50,000, held during the study and for one year after it ends.3eCFR. 21 CFR 54.2 – Definitions
- A proprietary interest in the tested product, such as a patent, trademark, copyright, or licensing agreement.
- Significant payments of other sorts from the sponsor totaling more than $25,000 during the study and the year after, covering things like research grants, equipment, consulting retainers, or honoraria, but excluding the direct costs of running the study.3eCFR. 21 CFR 54.2 – Definitions
These thresholds sweep in the investigator’s spouse and dependent children, not just the investigator personally.4GovInfo. 21 CFR Part 54 – Financial Disclosure by Clinical Investigators Build the household into your questionnaire before you check any box on the form.
Filling Out the Form
Before you open the PDF, pull together the legal name of the applicant or sponsor, the identifying numbers and titles of each covered clinical study, and a finalized list of every listed or identified investigator and subinvestigator who was directly involved in treating or evaluating research subjects.5eCFR. 21 CFR Part 54 – Definitions
Choosing One of the Three Certification Statements
The form gives you three options. You pick one based on your role in the study and what your vetting turned up.
Option 1 is for a sponsor certifying its own studies. You attest that you have not entered into any financial arrangement where an investigator’s compensation could be influenced by study outcome, and that each listed investigator has no proprietary interest in the product, no significant equity interest in your company, and has not received significant payments of other sorts from you. Investigator names go on the form or on an attached list.6Food and Drug Administration. FDA Form 3454 – Certification: Financial Interests and Arrangements of Clinical Investigators
Option 2 is for an applicant submitting studies that were sponsored by someone else. You certify that, based on information obtained from the sponsor or from the participating investigators, the listed investigators had no disclosable financial ties to the sponsor.6Food and Drug Administration. FDA Form 3454 – Certification: Financial Interests and Arrangements of Clinical Investigators
Option 3 is the due-diligence fallback. You certify that you made a good-faith effort to obtain the required financial information but were unable to get it, and you attach an explanation of why.6Food and Drug Administration. FDA Form 3454 – Certification: Financial Interests and Arrangements of Clinical Investigators Treat this as a last resort. FDA can refuse to file the application if the explanation is thin, so keep records of your outreach — emails, letters, follow-up calls — before you rely on it.2eCFR. 21 CFR Part 54 – Financial Disclosure by Clinical Investigators
Attaching the Investigator List and Signing
Whichever option you pick, you must attach the list of investigators the certification covers. The form points to that attachment explicitly, and omitting it is one of the easiest ways to draw a filing deficiency. Match the names to what appears in the clinical data and any prior FDA submissions.
The form has to be signed and dated by the applicant’s chief financial officer or another responsible corporate official.2eCFR. 21 CFR Part 54 – Financial Disclosure by Clinical Investigators The signature is a formal attestation that the vetting was completed and the information is accurate. Date the form to reflect when the vetting was actually finalized.
Where the Form Goes in Your Submission
Form 3454 is never filed on its own. It rides inside the marketing application it supports — the NDA, BLA, PMA, 510(k), or supplement. In an Electronic Common Technical Document submission, financial certification and disclosure forms sit in Module 1 under administrative information.7Food and Drug Administration. eCTD v4.0 Comprehensive Table of Contents Headings and Hierarchy Putting it in the wrong module, or leaving it out, can trigger a technical rejection before anyone at the agency looks at the clinical data.
Separately from the Form 3454 attachment, the applicant must submit a complete list of all clinical investigators who conducted covered studies, identifying which of them are full-time or part-time employees of the sponsor.8eCFR. 21 CFR 54.4 – Certification and Disclosure Requirements That master list covers every investigator on the application, whether certified on 3454 or disclosed on 3455.
What FDA Can Do If the Certification Fails
The agency reviews the financial certification as part of its check on the integrity of your clinical data. If a financial interest raises a serious question about data reliability, FDA can:
- Audit the data from the investigator in question
- Ask for additional analyses showing how that investigator’s data affected overall study outcomes
- Require independent studies to confirm the results
- Refuse to treat the covered study as a valid basis for agency action
That last option effectively throws the study out for regulatory purposes. An inaccurate certification can also lead FDA to refuse to file the marketing application at all.2eCFR. 21 CFR Part 54 – Financial Disclosure by Clinical Investigators Most sponsors handle the vetting during trial startup rather than at the application stage for this reason.
Records You Must Keep After Filing
Submitting the form doesn’t close out the obligation. Sponsors have to retain all financial records collected from clinical investigators for at least two years after FDA approves the marketing application, and FDA can inspect and copy those records at reasonable times during that period.9eCFR. 21 CFR 54.6 – Recordkeeping and Record Retention Keep the questionnaires, certifications, and correspondence organized by investigator so you can produce them if the agency comes back with questions after approval.