Clinical Trials Toolkit Routemap

Clinical Trial Summary Report

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Trial Close-Out Phase

The Clinical Trial Summary Report station follows the Statistical Data Analysis station and precedes the Dissemination of Results station. The Clinical Trial Summary Report is good practice and is relevant to all trials. This station is part of the 'trial close-out phase' group of stations.

Clinical Trial Summary Report

The amended Clinical Trials Regulations require a summary of trial results for clinical trials of investigational medicinal products (CTIMPs) and IMP/Device trials, including key outcomes, to be published in the public registry* where the trial is registered. This should occur:

  • Within 6 months of the global end of the trial for paediatric clinical trials
  • Within one year of the global end of the trial for non-paediatric clinical trials 

Once published, a confirmatory email should be sent to CT.Submission@mhra.gov.uk. Further details can be found on the MHRA webpages.

* The Health Research Authority (HRA) confirm that if the public registry does not have a results section, the results should be posted on a free-to-access, publicly available, searchable institutional website of the sponsor, funder or chief investigator.

Lay Summaries 

Under the amended Clinical Trials Regulations , lay summaries of the results should also be offered to participants or, where appropriate, the person who provided consent on their behalf within 12-months. An HRA Blog provides further detail.

Non-CTIMPs

The HRA confirms that a final report on the research should be provided to the REC within 12 months of the conclusion of the study. Guidance on ending a project is available on the HRA website. Transparency expectations, including the public posting of trial results, are available on the HRA website.

Further Reading

  • HRA: Make it Public: transparency and openness in health and social care research.
  • MHRA: Transitional arrangements for transparency for applications submitted before 28 April 2026.
  • MHRA: Completed paediatric studies: Submission, processing and assessment.
  • HRA Blog: Research transparency and transitional arrangements.