Zdrowie i gospodarka · 28.03.2005
Draft Guidance for Industry on Using a Centralized Institutional Review Boards Process in Multicenter Clinical Trials; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Using a Centralized IRB Process in Multicenter Clinical Trials." The draft guidance is intended to assist sponsors, institutions, institutional review boards (IRBs), and clinical investigators involved in multicenter clinical research in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's regulations by facilitating the use of a centralized IRB review process.