{{Short description, Document providing much detail about the methods and results of a trialIn
medicine
Medicine is the science and practice of caring for a patient, managing the diagnosis, prognosis, prevention, treatment, palliation of their injury or disease, and promoting their health. Medicine encompasses a variety of health care pr ...
, a clinical study report (CSR) on a
clinical trial
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, diet ...
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-review
Peer review is the evaluation of work by one or more people with similar competencies as the producers of the work ( peers). It functions as a form of self-regulation by qualified members of a profession within the relevant field. Peer revie ...
ed academic paper. 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 ,_Statins_have_no_side_effects?_This_is_what_our_study_really_found_…,_Guardian_newspaper,_15_March_2014.html" ;"title="Ben Goldacre">Ben Goldacre , Statins have no side effects? This is what our study really found …, Guardian newspaper, 15 March 2014">Ben Goldacre">Ben Goldacre , Statins have no side effects? This is what our study really found …, Guardian newspaper, 15 March 2014/ref>
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; 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. Recommended prerequisites and content for producing a report conformant to ICH guidelines have been outlined by SE Caldwell.Things Medical Writers Need for Clinical Study Reports (CSRs) /ref> In the Nov 9, 2016 addendum to the ICH guidelines Canada and Switzerland were added to the countries which would accept the unified standard.