다기관 임상시험에서의 공동IRB의 필요성 및 IRB심사의 시스템화 전략 모색

초록

Purpose : Recently, with the development of science and technology and the expansion of research scale, the number of multicenter clinical trials involving more than one institution is increasing. Accordingly, byestablishing a standard and computerized system for IRB examination, we intend to present a strategy that can be expected to shorten the examination period and reduce examination costs with an efficientexamination system. Methods : The necessity of joint IRB and regulations for operation were reviewed. The points to be considered for the establishment of the e-IRB system were reviewed. Results : It confirmed that the need for a joint IRB was clear. Problems and solutions to be solved for the concrete realization of the joint IRB were presented. Functions and interlocking methods for reviewingdomestic and foreign regulations and system construction were presented. Conclusion : Through this paper, it is expected that medical institutions will become aware of the importance and necessity of an efficient and flexible joint IRB in line with the rapidly changing medicalindustry. In fact, it is expected that it will be able to contribute to understanding the precautions on how to organize and operate a joint IRB.

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