Form FDA 3674: Certifying ClinicalTrials.gov

Form FDA 3674 is a one-page form with fifteen fields, and almost all of the risk sits in field 9: a single choice among three check boxes labelled A, B and C. Pick the wrong one and you have not made a paperwork error — you have signed an inaccurate statement about the regulatory status of your own clinical trials, under a form that carries an explicit criminal-offence warning. The form is easy. The determination behind it is not.

The most common error is checking Box A because you do not yet have an NCT number. That is almost always wrong, and this guide is organised around getting that decision right.

The one determination that decides the form

The three boxes are not “no trials / small trials / big trials.” Per the instructions printed on the back of the form, they are three distinct legal conclusions the signer is asserting, evaluated as of the date the certification is signed:

Box A — the requirements of 42 U.S.C. § 282(j) do not apply because the application or submission does not reference any clinical trial. The instructions gloss this as: no clinical trials are included, relied upon, or otherwise referred to in the submission. Box A is a statement about the contents of your submission, not about whether your trial is registrable.
Box B — the submission does reference one or more clinical trials, but as of the signature date § 282(j) does not require that any information be submitted to the data bank with respect to them. The instructions are unusually explicit that this can be true even when the trials are “applicable clinical trials”: the duty simply has not attached yet.
Box C — the requirements do apply, as of the signature date, to one or more of the referenced trials, and those requirements have been met.

So the decision tree is: does the submission reference a clinical trial at all? If no, Box A. If yes, is anything actually due to ClinicalTrials.gov today for any of them? If no, Box B. If yes, you must have already done it, and you check Box C.

Why “I have no NCT number yet” does not mean Box A

Registration is not due when a trial is designed or when an IND is filed. Under 42 CFR 11.24(a), clinical trial registration information must be submitted no later than 21 calendar days after the first human subject is enrolled. An original IND is typically filed months before anyone enrols. On the day you sign, the submission plainly references a clinical trial — the protocol is in the package — so Box A is factually false. But nothing is yet due, so nothing has been violated. That is precisely the situation Box B exists to describe.

People reach for Box A because it is the only box that obviously does not ask for an NCT number. Box B does not ask for one either.

Box C without an NCT number is explicitly allowed

This surprises people, and it stalls submissions unnecessarily. The instructions for field 10 state that you should leave the NCT field blank if you have checked Box 9.C but, at the time the certification is completed, you have not yet received any NCT numbers for the applicable clinical trials referenced. You are not blocked. Two related field-level details: enter only the digits, because the form prepends “NCT” automatically, and attach extra pages if one certification covers several trials.

A worked case: the phase 1 IND

A first-in-human phase 1 study under a new IND references a clinical trial, so Box A is out. Is it an applicable clinical trial? Under 42 CFR 11.10, an applicable drug clinical trial is a controlled clinical investigation other than a phase 1 clinical investigation of a drug or biological product. A phase 1 trial is therefore not an applicable clinical trial, nothing is required to be submitted to the data bank for it, and the analysis lands on Box B — even though the IND itself still needs a 3674 attached.

Note the asymmetry that catches device sponsors: the phase-1 carve-out has no device analogue. Under 42 CFR 11.22(b)(1), a device study is an applicable device clinical trial if it is interventional, has a primary purpose other than feasibility, studies an FDA-regulated device product, and has a US facility location, a US-manufactured-and-exported product, or an FDA IDE number. There is no early-phase exclusion.

Which submissions actually need a 3674

The statute, 42 U.S.C. § 282(j)(5)(B), attaches the certification to applications under sections 505, 515 or 520(m) of the FD&C Act or section 351 of the PHS Act, and to reports submitted under section 510(k). FDA’s June 2017 guidance then works out what that means in practice and recommends a 3674 accompany the following, including resubmissions:

IND
New clinical protocol submitted to an IND
NDA, and an efficacy supplement to an approved NDA
BLA, and an efficacy supplement to an approved BLA
ANDA
PMA, and a PMA panel track supplement
HDE
510(k) that refers to, relates to, or includes information on a clinical trial

If you are assembling an original IND, the 3674 travels alongside the Form FDA 1571 cover sheet rather than replacing anything on it.

The exclusions that save the most time

Amendments to a pending application do not need one. FDA’s reasoning is that an amendment to a pending application, pending supplemental application, or pending 510(k) is not itself independently an “application” or a “submission of a report under 510(k),” so the statutory trigger never fires.

IND amendments are the same — with one carve-out. Certifications need not be submitted with IND amendments other than submission of a new protocol to an existing IND. FDA treats a new protocol as the investigational-stage analogue of an efficacy supplement, and requires the form there. So: safety reports, information amendments and annual reports, no; a genuinely new study protocol, yes.

An IDE does not need one. FDA states plainly that federal law does not require submission of a Form FDA 3674 with an Investigational Device Exemption application. This is the split that most often goes wrong on the device side, because it is easy to over-read: an IDE study can still be an applicable device clinical trial that must be registered under 42 CFR part 11. No certification form does not mean no registration duty.

Four categories sit under enforcement discretion. FDA has said it intends to exercise enforcement discretion for: supplements to an approved NDA, BLA or PMA other than efficacy or panel-track supplements; supplements to an approved ANDA; INDs of the types described in section 561 of the FD&C Act (expanded access, which 42 CFR 11.10 excludes from the definition of applicable clinical trial outright); and 510(k)s that do not refer to, relate to, or include information on or from a clinical trial. The stated rationale is that certifying repeatedly about trials already certified during the investigational phase serves no purpose.

Filling the form without generating a query

Most 3674 deficiencies are clerical and entirely avoidable:

Field 1 must match exactly. The instructions require the sponsor/applicant/submitter name to be identical to the name listed on the application. A parent-company name on the 3674 and a subsidiary on the application is a mismatch.
Field 2 and field 15 are different dates. Field 2 is the date of the application the certification accompanies; field 15 is the date the certification is signed. The instructions note explicitly that these may differ — and since the A/B/C determination is made as of the signature date, a form signed weeks early can become stale. If first enrolment happens between signing and filing, re-run the determination.
Field 7 versus field 8. Field 7 takes a previously assigned application number if one exists (for a protocol amendment to an issued IND, that IND number). Field 8 takes a sequential serial number if the application has one; the instructions say to leave it blank if there is none.
Field 6 has a PDP box and an “Other” box. If your submission type is not listed, check Other rather than forcing a near-match.
Field 11 signature authority. If the signer is not the sponsor/applicant/submitter, the instructions require that they be an authorised representative.

The expiration date on the form is not a problem

The PDF FDA distributes is stamped “Form FDA 3674 (11/08)” and carries OMB No. 0910-0616 with an expiration date of 10-31-2011. This reliably alarms people who assume they have downloaded a superseded version. FDA’s published position is that when forms in use reach their expiration date, FDA works with OMB to renew them, and the forms posted on FDA’s site may be used during this time. Download from FDA’s clinical trial forms page and use what is there; if you are unsure, FDA directs the question to your regulatory project manager.

What a bad certification actually costs

Four things are prohibited acts under section 301(jj) of the FD&C Act (21 U.S.C. § 331(jj)): failing to submit the required certification, knowingly submitting a false certification, failing to submit required clinical trial information, and submitting clinical trial information that is false or misleading. 42 CFR 11.66 restates this.

The civil monetary penalty runs through 21 U.S.C. § 333(f)(3). The statutory figures are not more than $10,000 for all violations adjudicated in a single proceeding, plus not more than $10,000 for each day the violation continues after a 30-day correction window following notification. Those figures are adjusted annually for inflation; in the HHS penalty table at 45 CFR 102.3, the 2025 maximum adjusted amount for both is $15,107. Check the current table rather than quoting the statutory number.

Separately, the form’s own signature block warns that a wilfully and knowingly false statement is a criminal offence under 18 U.S.C. § 1001. And under 42 CFR 11.66(c), if an applicable clinical trial is HHS-funded in whole or part and required registration and results submissions are not verified, remaining or future grant funding will not be released, after a 30-day notice to correct.

How much of this is actually enforced

Honest answer: enforcement is real but narrow, and it has so far targeted the underlying registration and results duties rather than the certification form. FDA’s process runs Pre-Notice for potential noncompliance, then Notice of Noncompliance, then possible civil money penalties if adequate corrective action is not taken within 30 calendar days. FDA’s public table of Notices of Noncompliance listed eight responsible parties as of its 5 February 2026 update, spanning 2021 to 2025; the “Civil Money Penalty Amount (if any)” column was blank for every entry. Treat that as a description of a young enforcement programme, not as evidence the requirement is optional.

Where the 3674 fits in the wider ClinicalTrials.gov obligation

The certification is a checkpoint, not the obligation itself. The substantive duties — registering within 21 days of first enrolment, keeping the record current, submitting results information — live in 42 CFR part 11 and are discharged through the Protocol Registration and Results System (PRS). Academic sponsor-investigators in particular should work through ClinicalTrials.gov registration requirements for investigator-initiated trials before signing anything, because on an investigator-held IND the same person is often both the responsible party and the certifier.

One consequence worth knowing: under 42 U.S.C. § 282(j)(3)(F), FDA must notify the NIH Director of certain actions taken on applications and reports that were accompanied by a certification. That notification is what alerts NIH that results information will be due within a defined period. The NCT numbers you supply in field 10 are also what let FDA link its own public output — reviews, advisory committee actions, safety communications — to specific registered trials. A sloppy field 10 degrades a public record, not just your file.

Frequently asked questions

Do I need a Form FDA 3674 for every submission to my IND?

No. FDA’s guidance says certifications need not be submitted with IND amendments other than the submission of a new protocol to an existing IND. Safety reports, information amendments and annual reports do not need one; a new study protocol does.

What do I check if my trial has not started enrolling?

If the submission references the trial, Box A is wrong. Because registration is not due until 21 calendar days after the first subject is enrolled (42 CFR 11.24(a)), nothing is required of you on the signature date, which is the situation Box B describes. Re-check the determination if enrolment begins before you file.

Can I submit Form FDA 3674 without an NCT number?

Yes. The instructions direct you to leave field 10 blank if you have checked Box 9.C but have not yet received NCT numbers for the applicable clinical trials referenced. Boxes A and B do not call for NCT numbers at all.

Does an IDE application need a Form FDA 3674?

No. FDA states that federal law does not require a Form FDA 3674 with an Investigational Device Exemption application. The registration obligations under 42 CFR part 11 still apply to the study if it meets the applicable device clinical trial criteria.

Does a 510(k) need one?

Only if the 510(k) refers to, relates to, or includes information on a clinical trial. FDA intends to exercise enforcement discretion for 510(k) submissions that do not.

The form says it expired in 2011. Is it still valid?

Yes. FDA’s stated policy is that when a form in use reaches its expiration date, FDA works with OMB to renew it, and the forms posted on FDA’s website may be used in the meantime.

Is a phase 1 trial an applicable clinical trial?

No. 42 CFR 11.10 defines an applicable drug clinical trial as a controlled clinical investigation other than a phase 1 clinical investigation. There is no equivalent early-phase exclusion for devices.