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

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

임상시험심사위원회의 개선방안: 지속관리를 중심으로

The Suggestions for Improving the Institutional Review Board (IRB) in Clinical Trials: Focusing on Continuing Management

  • 신희영 (전남대학교 의과대학 의생명과학교실, 전남대학교병원 임상시험센터)
  • Shin, Hee-Young (Department of Biomedical Science, Chonnam National University Medical School, Clinical Trial Center, Chonnam National University Hospital)
  • 투고 : 2011.02.28
  • 심사 : 2011.04.08
  • 발행 : 2011.06.30
⟨ 이전 논문 다음 논문 ⟩

초록

As Korea has increasing number of clinical trials in recent years, institutional review boards (IRBs) are facing new challenges. The IRB should review submitted documents and supervise clinical trials from the beginning to the end to protect human subjects. Although most IRBs invest much time and efforts to initial review, they rarely conduct proper continuing management at the moment. The purpose of this article is to describe challenges involving continuing management, which includes unanticipated problems, subject's complaints, site visit, and continuing review, and to provide suggestions for improving it. Above all, institutions should perceive the importance of continuing management and they should provide sufficient manpower and resources for the management.

키워드

참고문헌

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