Critical Review of Trial Results
1. What is a clinical study report?
The clinical study report (CSR) is the formal document describing the results of a clinical trial. It therefore represents a fundamental building block in the argument for use of the treatment in humans. The results of all clinical trials conducted in humans must be recorded in a clinical study report.
The E3 Guideline defines the type of report to be used for most clinical trials conducted in three major geographic regions (Europe, Japan, and the United States) (link).
This report usually runs to several hundred pages. Clinical study reports are prepared by the trial sponsor and forwarded to regulatory authorities.
Access to such reports or even summary data will be possible in the future via the EU database: here.