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.
- EUPATI-Accademia del Paziente esperto (AdPEE) Toolbox Glossary: https://toolbox.eupati.eu/glossary/clinical-study-report/
More resources
- EMA Eu: FAQs Clinical Study Report submission, CTIS Training Programme – Module 13 Version 1.1 – October 2022: https://www.ema.europa.eu/system/files/documents/other/cttm13_-_faqs-en.pdf
- Massachusetts Institute of Technology (MIT). The Mayfield handbook of technical and scientific writing: https://web.mit.edu/course/21/21.guide/rep-resc.htm
- World Health Organization (WHO) Recommended format for “Public disclosure of clinical trial results”: https://www.who.int/clinical-trials-registry-platform/reporting-on-findings
