Clinical study report

In medicine, a clinical study report (CSR) on a clinical trial is a document, typically very long, providing much detail about the methods and results of a trial. A CSR is a scientific document addressing efficacy and safety, not a sales or marketing tool; its content is similar to that of a peer-reviewed academic paper.[1] Results of trials are usually reported in a briefer academic journal paper, but methodological flaws are often glossed over in the briefer paper.[2]

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a body bringing together the regulatory authorities and pharmaceutical industry of Europe, Japan and the US to discuss scientific and technical aspects of drug registration;[3] in 1995 it produced a tripartite harmonised ICH guideline on the format and content of a study report to be acceptable in all three ICH regions.[4] Recommended prerequisites and content for producing a report conformant to ICH guidelines have been outlined by SE Caldwell.[5] In the Nov 9, 2016 addendum to the ICH guidelines Canada and Switzerland were added to the countries which would accept the unified standard.