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Zdrowie i gospodarka · 4.10.2004

Draft Guidance for Industry on Computerized Systems Used in Clinical Trials; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Computerized Systems Used in Clinical Trials." This document provides guidance about computerized systems that are used to create, modify, maintain, archive, retrieve, or transmit clinical data required to be maintained and/or submitted to FDA. This draft guidance, when finalized, will supercede the guidance of the same name issued in April 1999.

Source: Federal Register — Food and Drug AdministrationOpen original release →