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

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

Improving the Efficiency of IRB through Joint IRB in Multicenter Clinical Trials in Korea

공동심사위원회를 통한 임상시험심사위원회 효율성 제고

  • Shin, Hee-Young (Department of Biomedical Science, Chonnam National University Medical School, Clinical Trial Center, Chonnam National University Hospital)
  • 신희영 (전남대학교 의과대학 의생명과학교실, 전남대학교병원 임상시험센터)
  • Received : 2009.04.10
  • Accepted : 2009.04.30
  • Published : 2009.06.30

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Abstract

As there has been substantial increase in the number of multicenter clinical trials in Korea, sponsors and investigators are concerned about the duplication of effort and delay by multiple IRB reviews. To enhance the efficiency of IRB in multicenter studies, the introduction of joint IRB or central IRB has been discussed. Although the Korean Good Clinical Practice(KGCP) was revised to accept centralized IRB review process in 2007, joint IRB has not been used in most institutions. Two models of joint IRB, single non-profit IRB and multiple lead IRBs, are applicable considering the current situations of IRB in Korea. The concept and operation of the two models have been described in this article. The governmental initiative and operational guidelines are the prerequisites for the successful implementation of the nationwide joint IRB in Korea.

Keywords

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