How to prepare Forms FDA 3454 and 3455 financial disclosures

How do you prepare Forms FDA 3454 and 3455?

First identify covered studies and reconcile their investigators, sponsor relationships and financial information. Select the applicable certification or disclosure from documented facts; unresolved information needs a supported disposition. Match forms and attachments to that roster, describe actual measures addressing potential bias, and obtain review and execution by the responsible applicant official.

Before you begin

Marketing applications containing covered clinical studies under 21 CFR Part 54. IND-stage information collection supports later disclosure; it is not the same filing trigger.

What you will prepare: An investigator reconciliation and evidence-supported form package ready for authorized execution.

Define the studies and people before selecting a form

A covered study is determined by its role in the marketing application, using §54.2(e), not simply its phase label. The rule covers studies relied on for effectiveness, including equivalence, and studies in which a single investigator makes a significant safety contribution. Record the rationale for each study’s disposition.

Build a roster of investigators and subinvestigators directly involved in treatment or evaluation, identify sponsor employees and account for the defined spouse/dependent-child interests. Reconcile names and study IDs with the clinical reports and investigator records. Do not indiscriminately count every laboratory employee or silently omit a covered investigator because a form is missing.

Choose the certification or disclosure from confirmed facts

Form 3454 supports the applicable certification; Form 3455 discloses reportable interests/arrangements and steps taken to minimize bias. Part 54 also provides a due-diligence certification when the applicant tried but could not obtain information, with the reason. “No response” is not “no financial interest.” Use the appropriate current form option and supporting explanation.

Check product/application identity, study scope, investigator attachments, selected statement and responsible corporate official’s signature/date. Where a certification covers less than all covered clinical data, identify the studies it covers. For a disclosure, describe the nature of the interest and the actual bias controls, rather than asserting “no effect on results” without an analysis.

Apply the correct financial category and period

Section 54.2 distinguishes outcome-dependent compensation, proprietary interests, significant equity and significant payments of other sorts. Its publicly traded equity threshold is more than $50,000; interests whose value cannot readily be determined from public prices have a different definition. Significant other payments exceed $25,000 and exclude the costs of conducting the clinical studies. The relevant definitions and update duty extend through one year after study completion.

Have the financial-information owner apply those definitions to the actual arrangement. Do not apply the publicly traded threshold to private-company equity, or use a payment amount alone without determining what it paid for.

Worked check: private equity and a missing response

Fictional exercise: Investigator A holds private-company options; Investigator B has not answered repeated documented requests. Do not clear A by comparing the options with the public-equity threshold. For B, retain the actual attempts, investigate alternate sources and have the responsible owner determine whether the due-diligence statement is supportable.

Change the scenario to a study not relied on for effectiveness and with no significant single-investigator safety contribution: reassess covered-study status from §54.2(e), not from the mere existence of a CSR. Missing study-purpose information leaves coverage undetermined.

Reconcile people, interests and supporting attachments

Build one working row for each relevant investigator–study relationship. An investigator may appear in more than one study, and the sponsor or financial arrangement may differ. This internal table helps review the package; it is not a substitute for an FDA form.

Keep identified sponsor employees in the roster; do not make them disappear when determining the applicable certification/disclosure population. For everyone requiring a disposition, record the source of the information and its covered period. An undated questionnaire can leave a timing gap even when every box is checked.

Payment exercise: an institution’s invoice combines study-conduct costs with payment for separate consulting work. Ask the financial owner to identify the activities and applicable categories before applying a threshold. Treating the entire invoice as either routine study costs or reportable other payments can produce the wrong conclusion. Preserve the category analysis supporting the final answer.

For a missing response, keep the actual contact attempts and review other reasonably available reliable information. FDA’s guidance describes reasonable efforts using more than one contact method in most cases; it does not create an automatic clearance after a fixed number of emails.

The official forms inspected October 6, 2026 have 2/26 and 4/26 footers for 3454 and 3455 respectively. Both display July 31, 2028 as the OMB expiration date. Reconcile application identity with Form 356h and the final attachment map with the submission reviewer guide.

Frequently asked questions

Sources and revisions

Requirements, source recommendations and editorial preparation advice have different roles. Review the scope and revision of the source you use.

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