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 Agencylink opens in a new page 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 1901/2006link opens in a new page. 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’link opens in a new page and sets out the minimum requirements for the final summary report to the HREC.

Information for Participants

The EU Clinical Trials Registerlink opens in a new page 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 contain the elements outlined in Annex V of Regulation (EU) No 536/2014(pdf, 84.94 KB).

In addition, the HRA webpageslink opens in a new page offer guidance on providing information to participants at the end of a study.