What is a Clinical Study Report (CSR)?
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.
What is a Clinical Study Report (CSR)?
A clinical study report (CSR) is a detailed scientific document that describes the methodology, conduct, and results of a clinical trial. According to the International Council for Harmonisation (ICH) E3 guideline, the CSR offers a transparent and objective account of the trial and serves as the foundation for regulatory submissions to agencies including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
In contrast to journal publications, which typically present findings in a condensed format, a CSR provides comprehensive details. The report includes study design and objectives, efficacy and safety outcomes, statistical analyses, and appendices containing supporting data.
The primary purpose of the CSR is to enable regulators and reviewers to assess whether the investigational product demonstrates sufficient safety and efficacy to warrant approval or continued development.
Fact: A Phase III clinical study report can run to over 1,000 pages, reflecting the complexity of late-stage trials and regulatory scrutiny.
Read Full Article on Clinion: Clinical Study Report (CSR): The Definitive Guide for 2026
Clinion’s CSR Automation
Clinion’s CSR Automation streamlines report preparation by using AI to extract information directly from the protocol, SAP, and TLFs. This process can automatically generate up to 70% of the content in a format aligned with ICH E3 guidelines. Medical writers then review and refine the draft, ensuring accuracy, context, and compliance before finalization.