Upon completion of a clinical trial, the sponsor is required to prepare a detailed report on the study.
Clinical Study Report
The content of CSRs is detailed in the ICH guideline E3. A clinical study report provides a clinical and statistical description, presentations and analyses of the completed study. The clinical study report should include an explanation of the critical design features, the plan, methods and conduct of the study, individual patient data and details of analytical methods.
CSR in the European Union
In the European Union, sponsors must submit the CSR summary within one year of the end of their clinical trial to regulatory authorities and ethics committees. The results of most clinical trials are published in the EU clinical trials registry and are therefore accessible to the general public. This information replaces the need to submit the CSR summary in some cases. The CSR will support a future marketing authorisation application.
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