The Clinical Trial Summary Report stationfollows 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.
It is a requirement to publish a summary of results for clinical trials of an investigational medicinal products (CTIMPs) 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.
The clinical trial summary report should be posted on the public register(s) where the trial was originally registered (see the Unique Trial Number Station). The MHRA do not require a copy of the clinical trial summary report but do require the sponsor (or their delegate) to send a brief confirmatory email to CT.Submission@mhra.gov.uk once the result-related information has been uploaded. Further details can be found on the MHRA webpages.
The HRA website contains information on ‘End of Study’ and sets out the minimum requirements for the final summary report to the HREC as well as guidance on providing information to participants at the end of a study.