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

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

임상시험의 질 보증을 위한 점검의 개념과 수행

Concept and Application of Audit for Quality Assurance in Clinical Trials

  • 김선하 (서울대학교 의과대학 예방의학교실,서울대학교병원 임상시험센터) ;
  • 김화정 (서울대학교 의과대학 예방의학교실,서울대학교병원 임상시험센터) ;
  • 박병주 (서울대학교 의과대학 예방의학교실,서울대학교병원 임상시험센터)
  • Kim, Seon-Ha (Department of Preventive Medicine, Seoul National University College of Medicine, Clinical Research Center, Seoul National University Hospital) ;
  • Kim, Hwa-Jung (Department of Preventive Medicine, Seoul National University College of Medicine, Clinical Research Center, Seoul National University Hospital) ;
  • Park, Byung-Joo (Department of Preventive Medicine, Seoul National University College of Medicine, Clinical Research Center, Seoul National University Hospital)
  • 발행 : 2003.12.30

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초록

According to the ICH GCP, an audit is defined as 'a systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor's SOPs, GCP, and the applicable regulatory requirement(s).' An audit usually starts with planning: then, follow in-house evaluation, actual survey at the center, preparation of the audit report, and submitting it, in that order. The audit conducted by the Clinical Research Center at Seoul National University Hospital identified some errors most frequently observed: absence of source documents (63.9% of total subject center), discrepancies between CRFs (Case Report Form) and source documents (61.1%), inappropriate handling of essential documents (52.8%), informed consents inappropriately acquired (36.1%), and violations of the protocol (22.2%). Like this well-planned and standardized audit would give a way to more qualified clinical trials.

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