| 翻訳と辞書 |
MedDRA
MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical terminology dictionary (and thesaurus) used by regulatory authorities in the pharmaceutical industry during the regulatory process, from pre-marketing to post-marketing activities, and for data entry, retrieval, evaluation, and presentation. In addition, it is the adverse event classification dictionary endorsed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
Originally available in English and Japanese, MedDRA is now also translated into Chinese, Czech, Dutch, French, German, Hungarian, Italian, Portuguese and Spanish. MedDRA is widely used internationally, including in the United States, European Union, and Japan. Its use is currently mandated in Europe and Japan for safety reporting.
== Organization of the dictionary ==
The MedDRA dictionary is organized by System Organ Class (SOC), divided into High-Level Group Terms (HLGT), High-Level Terms (HLT), Preferred Terms (PT) and finally into Lowest Level Terms (LLT).〔(【引用サイトリンク】url=http://www.meddramsso.com/public_faq_meddra.asp )〕 In addition, the MedDRA dictionary includes Standardized MedDRA Queries (SMQs). SMQs are groupings of terms that relate to a defined medical condition or area of interest.
Individual cases are usually coded for data entry at the most specific (LLT) level, and outputs of counts or cases are usually provided at the PT level. The higher levels (HLT, HLGT and SOC) as well as SMQ are used for searching and for organisation and subtotalling of outputs.
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「MedDRA」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.
|
|