국내 임상시험 이상반응의 IRB 보고 및 관리현황 = A Study on Management and Report of Adverse Event in Clinical Trials

다국어 초록 (Multilingual 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.

참고문헌 (Reference)

• 1 신희영, "임상시험심사위원회의 개선방안: 지속관리를 중심으로" 대한임상약리학회 19 (19): 5-13, 2011
• 2 식품의약품안전청 의약품본부 임상관리팀, "임상시험 이상반응보고 업무지침" 2007
• 3 식품의약품안전청, "임상시험 관련 순회교육. 임상시험 정책방향" 2011
• 4 식품의약품안전청, "약사법 시행규칙 별표3의2의약품임상시험관리기준"
• 5 "ICH-GCP E2A. Guideline for Industry. Clinical Safety Data Management: Definitions and standards for Expedited Reporting"
• 6 "Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events"
• 7 U.S. Department of Health and Human Services Food and Drug Administration, "Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs-Improving Human Subject Protection January 2009 Procedural"