Clinical study report [CSR]

A clinical study report is a document containing extensive detail 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 results of the trial. A clinical study report should also provide enough individual patient 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 authorisation, and it must meet the requirements of the regulatory authority that has to assess the application.

Recording and reporting clinical trial results
Clinical trial results are recorded in a clinical study report (CSR) in a prescribed manner; however, access to the CSR is usually limited. Summarised information from the CSR comes into the public domain via a number of routes.
Clinical study results: Publication
After they are published, clinical study results should be critically reviewed and assessed for such things as reliability, bias, significance, and fit with existing literature.

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Clinical study report [CSR]

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