Clinical Trial Summary Report

Clinical trial summary report

On 21 July 2014, it became mandatory for sponsors to post clinical trial summary results on the European Clinical Trials Database (EudraCT).

Reporting to Competent Authorities

The European Medicines Agency web page provides information on content of Summary Results to be posted by sponsors to competent authorities including Commission Guideline — Guidance on posting and publication of result-related information on clinical trials in relation to the implementation of Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation (EC) No 1901/2006. Timelines for reporting are as follows:

When the EU Clinical Trials Regulations come into force, summary results will be required to contain the elements outlined in Annex IV of Regulation (EU) No 536/2014(pdf, 16.15 KB).

Reporting to the REC

The HRA website contains information on ‘End of Study’ and sets out the minimum requirements for the final summary report to the HREC.

Information for Participants

The EU Clinical Trials Register provides the public with a subset of the information held in the EU clinical trials database, EudraCT. When the EU Clinical Trials Regulations come into force, summary results to participants will be required as outlined in the European Commission Guidance; ‘Summaries of Clinical Trial Results for Laypersons (2017)’.

In addition, the HRA webpages offer guidance on providing information to participants at the end of a study.