A clinical study report (CSR) is a document containing extensive details about the plan, methods and conduct of the study so that it is clear how the study was carried out. This report should provide a clear explanation of how the design features of the study were chosen and include the results of the trial.
A CSR should also provide enough data to allow the key analyses of data to be repeated, should the regulatory authorities wish to do so.
It is a central part of any application for a new medicine to receive marketing authorization, and it must meet the requirements of the regulatory authority that has to assess the application.
Glossary
Clinical study report (CSR)
