| 翻訳と辞書 |
| clinical study report ： ウィキペディア英語版 |
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.〔(Bellevue Medica: 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, 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;〔(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.〔(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.〔(Things Medical Writers Need for Clinical Study Reports (CSRs) )〕
==References==
〔
抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』
■ウィキペディアで「clinical study report」の詳細全文を読む
スポンサード リンク
| 翻訳と辞書 : 翻訳のためのインターネットリソース |
Copyright(C) kotoba.ne.jp 1997-2016. All Rights Reserved.
|
|