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KMID : 0391020060140020152
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Journal of Korean Society for Clinical Pharmacology and Therapeutics
2006 Volume.14 No. 2 p.152 ~ p.160
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A Questionnaire Survey for Evaluating Current Needs and Preferred Model of Joint Institutional Review Boards in Korea
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Kim Hwa-Jung
Kim Ock-Joo
Park Byung-Joo
Kim Seon-Ha
Lee Seung-Mi
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Abstract
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Background: Rapidly increasing scale of multicenter clinical studies (MCTs) is pressing the need of joint institutional review boards(IRB) in Korea. The purpose of this survey was to evaluate demand for joint IRE and appropriate form.
Methods: We constructed a questionnaire on the present IRE state on MCTs, agreement for joint IRB, ideal organization and operation method. This questionnaire was sent by mail to active clinical trial investigator group and head or secretary of all IREs registered to KFDA.
Results: Totally 187 participants replies, with 67.4% of investigators and 32.6% of head of IRBs. 79.9% responders reported repeated review on same MCT among each participating IRBs, and proportion of for and against of joint IBE were 74.3%, 24.1% respectively.
Discussion: Construction of joint IRB is supposed to have various strengths such as activation of MCTs due to reduced unnecessary review process, efficacy increment due to standardized review standards and resolutions. Before, preparatory works are necessary for successful achievement.
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KEYWORD
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Joint institutional review boards, Multicenter clinical studies, Questionnaire
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