Clinical study report

In medicine, a clinical study report (CSR) on a clinical trial is a very long and detailed document giving 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]

References

  1. ↑ Bellevue Medica: writing your first clinical study report
  2. ↑ Ben Goldacre, Statins have no side effects? This is what our study really found …, Guardian newspaper, 15 March 2014
  3. ↑ ICH Web site
  4. ↑ ICH: Structure and content of clinical study reports E3
  5. ↑ Things Medical Writers Need for Clinical Study Reports (CSRs)
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