5 Key Takeaways

• Clinical study reports (CSRs) are the definitive scientific records used by regulators to assess drug safety and effectiveness.
• Global standards such as ICH E3 and frameworks like CORE Reference and TransCelerate guide CSR structure and content.
• A complete CSR includes detailed sections covering study design, methods, results, and supporting documentation.
• Common CSR challenges include data inconsistencies, incomplete appendices, and weak version control.
• Early planning, cross-functional collaboration, and experienced medical writing are essential for high-quality, compliant CSRs.