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:
- Within 12 month of the ‘end of trial’ (see End of Trial Declaration station) for trials involving adults
- Within six months of the ‘end of trial’ for paediatric trials (see section 2.2.2 of Commission Communication 2009/C28/01)
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 contain the elements outlined in Annex V of Regulation (EU) No 536/2014(pdf, 84.94 KB).
In addition, the HRA webpages offer guidance on providing information to participants at the end of a study.