임상약리학회지 (Journal of Korean Society for Clinical Pharmacology and Therapeutics)

대한임상약리학회 (Korean Society for Clinical Pharmacology and Therapeutics)
권호 표지

약물 부작용 사례 코딩용어체계: MedDRA를 중심으로

A Review on Coding Dictionary for Safety Data: with Focus on the MedDRA

  • 안희정 (서울대학교병원 임상시험센터) ;
  • 김선하 (서울대학교 의과대학/서울대학교병원 의학연구협력센터, 서울대학교 의과대학 예방의학교실) ;
  • 한서경 (서울대학교 의과대학/서울대학교병원 의학연구협력센터) ;
  • 박병주 (서울대학교병원 임상시험센터, 서울대학교 의과대학/서울대학교병원 의학연구협력센터, 서울대학교 의과대학 예방의학교실)
  • Ahn, Hee-Jung (Clinical Research Center, Seoul National University Hospital) ;
  • Kim, Seon-Ha (Medical Research Collaborating Center, Seoul National University College of Medicine/ Seoul National University Hospital, Department of Preventive Medicine, Seoul National University College of Medicine) ;
  • Hahn, Seo-Kyung (Medical Research Collaborating Center, Seoul National University College of Medicine/ Seoul National University Hospital) ;
  • Park, Byung-Joo (Clinical Research Center, Seoul National University Hospital, Medical Research Collaborating Center, Seoul National University College of Medicine/ Seoul National University Hospital, Department of Preventive Medicine, Seoul National University College of Medicine)
  • 발행 : 2005.06.30

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초록

Costart, Whoart, and MedDRA have been widely used for classification of drug safety data for the purpose of analysis and retrieval. MedDRA is, however, different from the other dictionaries in many aspects, mainly in size, granularity, and its structure. The MedDRA is characterized by its hierarchical and, multiaxial features and its regular update, which can have an impact on the safety data analysis as well as a presentation of the data. The MedDRA is globally preferred as it is continuously updated by reflecting users requests, and many pharmaceutical companies and regulatory authorities required MedDRA as a compulsory for electronic transmissions. Therefore, understanding the coding system of MedDRA is very important for clinical investigators before they use it to record and report their drug safety data. An appropriate use of coding system should enhance the applicability of drug safety database.

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