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2011 (v.19 no.2)

The Journal of Korean Society for Clinical Pharmacology and Therapeutics

Korean Society for Clinical Pharmacology and Therapeutics
Semiannual
ISSN: 1225-5467

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

    Sehyun Lee, Yeong-In Kim, Hyeonwoo Yim, Gwihyang Lee, Byungin Choe

    J Korean Soc Clin Pharmacol Ther | v.19, no.2, pp.98-108, Dec, 2011

    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.

    Keyword

    Adverse event (AE), Suspected unexpected serious adverse reaction (SUSAR), Review and reporting of adverse event, Institutional review board (IRB)