An unabridged report of a clinical study written for regulators following the E3 reporting guidelines developed by the regulatory-industry collaborative effort International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). CSRs represent the most complete synthesis of the planning, execution, and results of a clinical trial. CSRs contain some of the same information as journal articles (i.e rationale, objectives, methodology, results, discussion/conclusion), but are substantially more detailed with numerous large tables and figures, and datasets not constrained by page limits. In addition, CSRs generally contain, as appendices, important study documents including the study protocol and amendments, statistical analysis plan and amendments, case report forms (CRFs), patient information sheet, certificates of analysis, informed consent forms, and individual patient listings among others.
Often referred to by its acronym, CSR.
Browse or download a sample CSR:
- 8,027 page CSR for AstraZeneca trial 5077US/0049
- 175 page CSR body and 4749 pages of appendices for Rowtasha trial MA-CT-10-002
- Download 107 clinical study reports: 77 for Tamiflu (oseltamivir) and 30 for Relenza (zanamivir)
Screenshot below: table of contents page from CSR of Tamiflu (oseltamivir) trial M76001 (source)
