Clinical Study Report (CSR)

A Clinical Study Report (CSR) is a detailed document that presents the results of a clinical trial, which tests new drugs or treatments on people. It summarizes the study's design, methods, findings, and conclusions, including how safe and effective the treatment was. A CSR is crucial for regulatory approvals, helping health authorities assess whether a new medication should be made available to the public. It typically includes data analyses, patient demographics, and a discussion of the implications of the findings, ensuring transparency and scientific integrity in the research process.