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Clinical Trial Registration During U.S. Government Shutdown

October 24, 2025

Background

The International Committee of Medical Journal Editors (ICMJE) requires that all interventional clinical trials be prospectively registered in a publicly accessible registry (e.g., ClinicalTrials.gov) prior to the enrollment of the first participant. This requirement is intended to ensure transparency, prevent selective reporting, and safeguard the credibility of published research.

As a result of the current U.S. government shutdown, the ClinicalTrials.gov website states, “Because of a lapse in government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted”.
 

Institutional Position

The University of Alberta Clinical Trials Office (CTO) recognizes the importance of compliance with ICMJE requirements and remains committed to transparency in clinical research. However, given the extraordinary circumstances of the U.S. government shutdown, the CTO has determined the following:

• Evidence of Registration Efforts
  Study teams who have initiated but cannot complete trial registration in ClinicalTrials.gov due to the shutdown may begin participant enrollment provided they retain clear documentation of attempted registration (e.g., screenshots, error messages, or email confirmations).

• Post-Shutdown Requirement
  Once ClinicalTrials.gov functionality is restored, trial registration must be completed without delay, with records updated to reflect accurate enrollment dates.

Rationale

This approach balances regulatory and ethical responsibilities by ensuring that:

• Trials are not unnecessarily delayed due to circumstances outside of investigators’ control.
• Participant access to time-sensitive interventions is not compromised.
• Registration requirements are met in good faith and retroactively reconciled once systems are operational.

Action for Study Teams

1. Attempt to initiate registration in ClinicalTrials.gov as per normal process.
2. Document any errors, access issues, or confirmation notices as evidence.
3. Maintain this documentation as a Note-to-File* in the Trial Master File (TMF) or Investigator Site File (ISF).
4. Complete registration as soon as ClinicalTrials.gov access is restored.
    

Follow along and subscribe to the CTO Connect Newsletter to keep up to date with the status of Clinicaltrials.gov 

*Already a member of the community of researchers? Click here to go directly to the template Note-to-File (fillable PDF format). Need access to the template Note-to-File? Click here to request.

Questions?

For assistance with documentation or registration once systems are operational, please contact the CTO.