At the end of a clinical trial, a Study Report must be produced, regardless of the success of the trial. The report should provide a clear explanation on the study design and all the relevant information about its conduction so that there is no ambiguity about how the study was carried out. The trial Sponsor or a delegate shall provide a summary of the CSR within one year of the end of the trial to the main Ethics Committee (EC) and the Competent Authority of the concerned member State(s).
