Abstract
To provide an efficient and high quality institutional review board (IRB) review for multicenter trials, a joint IRB (JIRB) was established in Taiwan in March 1997. The JIRB was authorized by 24 local IRBs to review 20 multicenter trials in the first year. The average time for protocol approval is 34.5 days. This new JIRB mechanism has improved Taiwan's competitiveness in successfully attracting multicenter trials, even Food and Drug Administration pre-New Drug Approval (NDA) trials, to Taiwan. The concept, objectives, review process, performance, and impact of the JIRB will be reviewed in this article.
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