Clinical study report

{{Short description|Document providing much detail about the methods and results of a trial}}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.[https://bellevuebiomedical.com/wp-content/uploads/2018/02/Writing-Your-First-Clinical-Study-Report.pdf Bellevue Biomedical: Writing your first clinical study report] Results of trials are usually reported in a briefer academic journal paper, but methodological flaws are often glossed over in the briefer paper. Ben Goldacre, [https://www.theguardian.com/science/blog/2014/mar/14/statins-side-effects-study-placebo-ben-goldacre Statins have no side effects? This is what our study really found …], Guardian newspaper, 15 March 2014

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;[http://www.ich.org/ ICH Web site] 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.[http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E3/E3_Guideline.pdf ICH: Structure and content of clinical study reports E3] Recommended prerequisites and content for producing a report conformant to ICH guidelines have been outlined by SE Caldwell.[http://biotechinkspots.com/medical-writing-how-to/48-things-medical-writers-need-for-clinical-study-reports/48 Things Medical Writers Need for Clinical Study Reports (CSRs)] In the Nov 9, 2016 addendum to the ICH guidelines Canada and Switzerland were added to the countries which would accept the unified standard.