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Clinical Trial Registration Following Resumption of U.S. Government Services

December 04, 2025

Background

In our October 24th CTO Connect Newsletter we provided the following information on public registration of trials on ClinicalTrials.gov during the shutdown of the U.S. government. 

"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”.

The University of Alberta Clinical Trials Office (CTO) issued interim guidance directing investigators to retain clear documentation of attempted registration (e.g., screenshots, error messages, or email confirmations) and to update records, as applicable, once ClinicalTrials.gov functionality has been restored.  

Updated Information

The U.S. government has now reopened and functionality of ClinicalTrials.gov has been restored.

Action for Study Teams

Registration of trials initiated during the shutdown, and updates to existing trials

1. Maintain documentation of registration attempts undertaken during the disruption as a Note-to-File* in the Trial Master File (TMF) or Investigator Site File (ISF).

2. Complete registration now that ClinicalTrials.gov access has been restored.

Registration of upcoming trials

1. Start trial registration on ClinicalTrials.gov as per normal process.

Follow along and subscribe to the CTO Connect Newsletter to keep up to date with the latest updates in clinical trials. 

*A template Note-to-File is available on the CTO Clinical Trial Resource Portal. 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.