Zdrowie i gospodarka · 16.03.2006
Guidance for Industry on Using a Centralized IRB Process in Multicenter Clinical Trials; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Using a Centralized IRB Process in Multicenter Clinical Trials." The guidance is intended to assist sponsors, institutions, institutional review boards (IRBs), and clinical investigators involved in multicenter clinical research in meeting the requirements of FDA regulations by facilitating the use of a centralized IRB review process.