clinical study report | csr clinical study | csr clinical trial
A clinical study report (CSR) is the most critical document produced from a clinical trial, providing regulators and stakeholders with a comprehensive, unbiased account of the study’s design, methodology, results, and conclusions. Unlike journal articles, a CSR follows strict ICH E3 guidelines and serves as the foundation for regulatory submissions and product approvals. This guide explains what a clinical study report is, its structure, types, challenges, regulatory updates, automation, and best practices.