Clinical trial report

You are required to submit the clinical trial report to the reviewing committee (MREC or CCMO) within one year of the end of the trial (worldwide). The CCMO does not send a confirmation of receipt. Do you need to submit the clinical trial report to an MREC? Ask the MREC in question what their policy is.

The competent authority must also receive the clinical trial report within one year of the end of the study (worldwide). The competent authority does not send a confirmation of receipt.

A model of a clinical trial report for research with a medicinal product can be found in ICH E3 Guideline on the contents and structure of clinical study reports (CPMP/137/95).

The CCMO statement publication policy gives the viewpoint of the CCMO on how they think the publication of clinical trial results should be carried out.

Research with a medicinal product: clinical trial results in EudraCT and the EU Clinical Trial Register

As of the autumn of 2014 the EMA has launched a new functionality to the EudraCT database for the reporting of the results of all approved clinical trials, which fall under the European Directive 2001/20/EC. This initiative is based on the European Commission Guideline concerning posting and publication of result-related information on clinical trials, the European Commission Guideline 2012/C 302/03.

For clinical research with medicinal products which falls under Directive 2001/20/EC, and which ended on or after 21 July 2014, the sponsor needs to add data of results to EudraCT. The results for most trials must be reported within 12 months after the end of the study. For trials that ended before 21 July 2014, sponsors will need to submit the results retrospectively.

Results will be published 15 days after a valid report in EudraCT, in the public EU Clinical Trial Register with the exception of most phase I trials in adults. If the sponsor does not report the results  (for most trials 15 months after the end of study) within the prescribed period in EudraCT, the study will be highlighted, which will be visible in the public EU Clinical Trials Registry.

Sponsors need to register on the EudraCT website to be able to add this data to EudraCT.

The current obligation to submit of the study report to the MREC and the Competent Authority, within one year after the end of study, remains unchanged.

More information can be found at the website of EMA.