clinical study report

A clinical study report (CSR) is a detailed document that summarizes the results of a clinical trial, which tests new medical treatments or interventions. It includes information about how the study was conducted, the data collected, and the outcomes observed. The CSR aims to provide a clear and comprehensive overview of the trial’s methodology and findings, ensuring transparency and supporting regulatory review by authorities like the FDA. Ultimately, it helps assess the treatment's safety and effectiveness, guiding future medical decisions and research.