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How should Form FDA 3674 be prepared?
First establish whether the actual transaction needs the certification, then identify the referenced trials and evidence supporting the applicable certification choice. Reconcile responsible-party and NCT information before signature. No trial inventory, no NCT number and proof of compliance are different states; none should be inferred from the others.
Before you begin
Clinical-trial compliance certification accompanying applicable submissions. Form selection and trial-registration/reporting applicability are separate assessments; lack of an NCT number is not an exemption determination.
What you will prepare: An evidence-backed certification decision, trial reconciliation record and correctly identified signer, or an explicit unresolved issue preventing signature.
Verify the form edition before execution
The official PDF inspected on September 22, 2026 has an 04/24 main-form revision and a printed OMB expiry of July 31, 2026. Confirm the currently accepted form through FDA before executing it; do not alter the footer or claim a renewal that has not been verified. The printed date alone is not a determination that the underlying certification obligation has ended. This guide explains the inspected choices and preparation method, not a finding that this downloaded edition is cleared for today’s filing.
Decide whether this transaction needs the certification
Use section III of the revised June 2017 final guidance to assess the actual transaction. A new IND protocol has a different certification treatment from other IND amendments; the word “amendment” alone is insufficient. The guidance also identifies enforcement-discretion categories, including specified supplements and expanded-access INDs. Record the relevant category and reasoning with the submission owner. An original application’s form packet is not a reliable template for every later transaction.
Build evidence for the certification choice
| Choice in the inspected form | Evidence needed | Unsafe shortcut |
|---|---|---|
| A: no referenced clinical trial | Review the actual submission and its references | Treating a missing trial spreadsheet as proof |
| B: requirements do not apply to any referenced trial | Document the assessment for every referenced trial | Assuming no NCT means not applicable |
| C: applicable requirements have been met | Responsible-party assessment and records supporting compliance | Equating registration alone with all applicable obligations |
Make one defensible selection. Reconcile the requested NCT information with the applicable trials for which the submitter is responsible, the dossier’s trial identifiers and the supporting records. Preserve unresolved applicability or reporting issues for the accountable owner; an assistant cannot choose a favorable certification to complete the form.
Fictional example: a trial appears only in an appendix
The initial worksheet says “no clinical trials,” but an appendix references a clinical study. Reopen the trial inventory and determine its relevance, responsible party and applicable obligations before selecting a certification. If the owner cannot establish whether required information was submitted, keep the form unsigned pending resolution. The correct output can be a documented blocker rather than a completed certificate.
Build the trial-level record before selecting a certification
Use one row per relevant trial as an internal aid, then assess the actual certification at submission level.
| Working field | Evidence to obtain | Unresolved condition |
|---|---|---|
| Trial identity | Dossier references, protocol code and registry identity where applicable | A cited trial is absent from the inventory |
| Applicability | Accountable assessment of the relevant obligations | A missing registry number is being treated as non-applicability |
| Responsible party | Actual party and relationship to the submitter | Responsibility is assumed from product ownership alone |
| Compliance support | Records supporting the applicable requirements | Registration is being treated as proof of every obligation |
| Form selection | Reconciled assessment across the referenced trials | One favorable trial record is generalized to the whole submission |
Review exercise: the main report contains no trial citation but an appendix does. Reopen the submission-wide inventory and assess the trial before choosing a certification. Do not make the inventory appear complete by excluding supporting documents from the review.
Retain the edition limitation described above: the inspected form’s printed expiration date is not evidence that the certification obligation ended or that a renewed edition has been verified. Resolve the actual edition and execution question without altering the source form.
Compare the inventory with the Module 5 study listing where applicable. For an IND transaction, reconcile the purpose with 1571; the word amendment is too broad to determine certification treatment.
Your preparation checklist
0/3 checkedUse this to track your review in this visit. Checks are not saved and do not establish regulatory compliance.
Frequently asked questions
Does every IND amendment need the same Form 3674 treatment?
No. FDA’s June 2017 guidance distinguishes submission of a new clinical protocol from other amendments to a pending IND. Determine the actual transaction and relevant category before deciding. Copying the original IND’s form packet does not establish the treatment of every later amendment.
Does having an NCT number prove all applicable requirements were met?
No. A registry identifier helps identify a trial but does not by itself establish compliance with all applicable requirements. The responsible owner needs the relevant applicability assessment and supporting records before the submitter selects the certification statement.
Does no NCT number mean the trial is outside the requirements?
No. A missing number may reflect a missing record or unresolved compliance question rather than non-applicability. Identify the trial and have the accountable owner assess its actual status. Do not use a blank field as the factual basis for a favorable certification.
Does the printed OMB expiration date end the certification obligation?
The printed date alone does not establish that conclusion. It also does not verify a renewal or current acceptance of the downloaded edition. Preserve the actual footer and confirm the form-edition question separately from the statutory and guidance-based applicability assessment.
Sources and revisions
Requirements, source recommendations and editorial preparation advice have different roles. Review the scope and revision of the source you use.
Form instructions
Form FDA 3674: Certification of Compliance ↗Main form and embedded instructions 04/24; continuation footer includes 04/23. Printed OMB expiry July 31, 2026 predates September 22 source check; current accepted edition must be confirmed before execution.
Guidance
FDA: Form 3674 Certifications Accompanying Applications and Submissions ↗Revised June 2017 final; section III submission categories, new IND protocols and enforcement discretion. Reopened September 22, 2026.
Technical specification · placement only
FDA eCTD v4.0 comprehensive hierarchy ↗Version 2.2, February 2025. Section 1.1. A heading identifies placement, not mandatory applicability.