Drug Evaluation Committee The sponsor's view on the use of joint IRBs, etc. (including central IRBs)
Clinical Evaluation Subcommittee
April 2012
The GCP Ministerial Ordinance of March 2008 abolished the principle of establishing an IRB for each medical institution, and the scope of use of joint IRBs, central IRBs, etc. (hereinafter referred to as "joint IRBs, etc.") was expected to expand and each medical institution was expected to actively utilize them, but they are not necessarily widely used. 5 examined the reasons for the lack of progress in the introduction and utilization of joint IRBs, etc., and discussed specific measures to promote their use. Since it is important to improve the function of IRB examination as well as the efficiency of joint IRBs, the report also includes the requirements for joint IRBs. In order for joint IRBs to spread, it is essential that not only medical institutions but also sponsors understand the importance of joint IRBs and that both parties utilize joint IRBs.
The sponsor's view on the use of joint IRBs, etc. (including central IRBs) (672KB)
Deliverables of the Drug Evaluation Committee Return to list of all deliverables