Clinical study report (CSR)

Comprehensive report of an individual study conducted in patients of any therapeutic, prophylactic, or diagnostic agent.

A CSR must include an explanation of critical design features of the study, methods and how the study was carried out, individual patient data, and details of analytical methods. The content of CSRs is specified in guideline E3 produced by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). They are submitted to regulatory authorities and ethics committees and are a key element of submissions for regulatory approval.

ICH Topic E 3 Structure and content of clinical study reports (EMA, 1996)

Guidance document: E3 Structure and content of clinical study reports

An insider’s guide to clinical study reports (Niche Science & Technology, 2019)