治験審査委具合ハンドブック

摘要

The regulatory requirements for the Institutional Review Board (IRB) and its members are defined in the Good Clinical Practice (GCP) ordinance under the Pharmaceutical Affairs Law. Although training for its members to ensure the quality of their protocol review has been long desired, it has not been sufficiently developed in Japan.To develop an IRB handbook as an educational resource for IRB members, which is to be further discussed and refined by the members themselves.We have searched and gathered several materials in Japan and abroad which are used as or related to educational guidebook/handbook for members of the IRB or the ethics committee.Additionally, we conducted interviews and discussions with people engaged in IRB work.Based on this information and also on our own experience,we held three meetings to develop and discuss the text of this handbook.We developed an IRB handbook that would be useful for IRB members in Japan.Discussion : While this handbook is deemed useful, it does not cover all the aspects of GCP-regulated clinicaltrials conducted in Japan. It should therefore be developed further based on comments received from thosewho have tried it as an educational resource.