A Study on Management and Report of Adverse Event in Clinical Trials

국내 임상시험 이상반응의 IRB 보고 및 관리현황

  • Lee, Se-Hyun (Office of Human Research Protection, Catholic Medical Center, The Catholic University of Korea) ;
  • Kim, Yeong-In (Department of Neurology, Seoul St. Mary's Hospital, The Catholic University of Korea) ;
  • Yim, Hyeon-Woo (Department of preventive medicine, College of Medicine, The Catholic University of Korea) ;
  • Lee, Gwi-Hyang (Nicholas Cardinal Cheong Graduate School for Life, The Catholic University of Korea) ;
  • Choe, Byung-In (Office of Human Research Protection, Catholic Medical Center, The Catholic University of Korea)
  • 이세현 (가톨릭대학교 가톨릭중앙의료원 연구윤리사무국) ;
  • 김영인 (가톨릭대학교 서울성모병원 신경과) ;
  • 임현우 (가톨릭대학교 의과대학 예방의학과) ;
  • 이귀향 (가톨릭대학교 생명대학원) ;
  • 최병인 (가톨릭대학교 가톨릭중앙의료원 연구윤리사무국)
  • Received : 2011.11.25
  • Accepted : 2011.12.24
  • Published : 2011.12.30

Abstract

Background: This research is to identify the difficulties occuring in the course of managing the adverse events and the adverse event related standard operating procedure in the regulation of each institutional review board. Methods: In order to identify the issues of the management of adverse events of each institution, this research surveyed the IRB administrators in fifty two university hospitals nation-wide. This survey is conducted among one chairman and one IRB member from the IRB members per each IRB who have experience in reviewing adverse events. The survey also includes investigators and sponsors who engage in reporting adverse events. Results: The result of this survey demonstrates that the objects and the terms of adverse event reports provided by the Standard Operating Procedure and the KGCP of each institution are not very different from each other. However, according to the survey, any cases reported to the IRBs, although they are not specified as the object of reports in the institution, have been reviewed by the IRB members. To sum up the results of the survey, the major issues include ambiguous regulations on adverse event reports and reviews, the use of different report formats for each institution, and the difficulty with evaluating the causal relationship with Investigational Product. Conclusion: It is necessary to develop concrete and specified guidelines on the objects and the terms of reports, the standard for the causal relationship and the adequate measures for adverse events after review and to standardize the format of adverse event reporting.

Keywords

Acknowledgement

Supported by : 식약청

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