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J Korean Soc Clin Pharmacol Ther. 2011 Jun;19(1):5-13. Korean. Clinical Trial.
Shin HY .
Department of Biomedical Science, Chonnam National University Medical School, Clinical Trial Center, Chonnam National University Hospital, Gwangju, Korea.

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.

Copyright © 2019. Korean Association of Medical Journal Editors.