What is a clinical study report?

A clinical study report (CSR) is a document that provides a detailed summary of the results of a clinical trial. The CSR is prepared by the sponsor of the trial (typically a pharmaceutical company or medical device manufacturer) and includes information on the design, conduct, and results of the trial.

The CSR is a comprehensive document that includes a range of information, including:

• A description of the treatment being studied and the study population
• The study protocol and any amendments to it
• The inclusion and exclusion criteria for the study
• The number and characteristics of the study sites and participants
• The results of the study, including any efficacy and safety data
• A summary of the statistical analyses conducted
• Any adverse events or other safety issues that were reported during the trial

The CSR is used by regulatory agencies, such as the US Food and Drug Administration (FDA), to evaluate the safety and effectiveness of a new medical treatment, drug, or device. It is also used by the sponsor of the trial to support the marketing and use of the treatment in clinical practice.