Routemap

Clinical Trial Summary Report

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.

A summary of results for clinical trials of investigational medicinal products should be published in the registry where the clinical trial is registered within 6 months of the end of trial for paediatric clinical trials or within one year of the end of trial for non-paediatric clinical trials.

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