Clinical trial disclosure compliance is no longer just about good documentation – it’s about timing, accuracy, and transparency across borders.

FDA Form 3674 is a required certification for nearly all U.S. clinical submissions, confirming trial registration and results reporting on ClinicalTrials.gov under the FDA Amendments Act (FDAAA) of 2007. But many teams still get it wrong, and the consequences include Refuse-to-File letters, submission delays, and audit findings. And now it’s not just the FDA watching. Global regulators—the EU, UK, Canada, and Australia—are tightening their own disclosure rules.

This newsletter breaks down:

• When Form 3674 is required (and often overlooked)
• Global equivalents and disclosure timelines
• Common missteps that delay approvals
• What top-performing clinical and regulatory teams do to stay ahead

🗂️ When You Need It

🔍 Common Misunderstandings

• Foreign Trials Still Count: Even if conducted outside the U.S., if the data supports a U.S. submission, Form 3674 applies.
• Sponsor vs. CRO: Responsibility rests with the sponsor, even if a CRO is managing the registry process.

🧩 Public Trust Boost

Scenario: A cardiovascular trial was registered early, and results were posted promptly on clinicaltrials.gov.
Outcome: The transparency led to increased exposure, higher patient enrollment in follow-up studies, and positive feedback from advocacy groups.
Lesson: Compliance isn’t just about avoiding penalties—it builds credibility.

⏱️ Clinical Trial Disclosure Compliance Timeline (U.S.)

🌍 How Other Regulators Address Trial Disclosure

💡 Tip!

Harmonize registry entries across CT.gov, CTIS, and ANZCTR to avoid mismatched trial metadata.

🧬Commonly Faced Challenges

Here’s where most people run into challenges with this form:

• ✅ Determining whether the clinical trial is “applicable”
  Not every study qualifies as an “applicable clinical trial” (ACT). Figuring out if a trial meets the ACT criteria can be tricky — it depends on the type of product, the phase, whether it has U.S. sites, and if it falls under FDA jurisdiction. Many sponsors struggle to correctly interpret the FDA and NIH definitions.
• ✅ Matching the submission timelines
  FDA requires you to certify at the time of NDA, BLA, IND, IDE, PMA, or 510(k) submissions. But ClinicalTrials.gov has its submission deadlines (see above). Ensuring you’re aligned on both sides is a compliance headache.
• ✅ Accurate and complete reporting
  Even if you certify on the form, if the actual records on ClinicalTrials.gov are missing or incomplete, you can still face FDA or NIH enforcement. So, it’s not just filing the form — it’s about ensuring the underlying data is right.
• ✅ Understanding the penalties
  Some companies underestimate the risks. Certifying compliance when you’re not compliant can lead to civil monetary penalties or other regulatory action.
• ✅ Coordination across teams
  The regulatory team submitting the FDA application may not be the same team handling ClinicalTrials.gov reporting. Poor internal coordination can lead to gaps or mistakes.

🧠 Note

The FDA is considering harmonization with EU CTIS data requirements post-2025, which could introduce multi-region certification checks.

🛠️What You Can Do: Best Practices for Global Sponsors, Regulatory, & Clinical Teams

• Use a Centralized Registry Tracker: Avoid data mismatch across CT.gov, CTIS, and protocols.
• Verify Start Dates & Primary Endpoints: Ensure consistency between registry and submission.
• Train Functional Teams: Educate clinical ops and medical writing teams on what qualifies as an “applicable trial.” Don’t assume the regulatory handles it alone.
• Integrate into SOPs: Make Form 3674 and registry updates part of your documented workflows.
• Audit early: Validate ClinicalTrials.gov entries before major submissions

✅ Sponsor Readiness Checklist

Conclusion: Compliance as a Strategic Advantage

In a landscape where trial transparency is increasingly linked to public accountability, early and consistent registration practices give sponsors a distinct advantage. It ensures regulatory momentum, avoids costly surprises, and positions your organization as a credible, ethical leader in clinical research.

And with global regulators moving toward harmonization, it’s never been more important to think beyond the U.S. Form 3674 and build a global clinical trial disclosure strategy that supports your submissions across borders.

📩 Need help with Form 3674 or global registry strategy?

Let’s streamline your process.
🔗 Ask for:

• Form 3674 sample package
• Global trial registration tracker (Excel template)
• Regulatory compliance calendar (customized to your pipeline)