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Zdrowie i gospodarka · 10.05.1999

Guidance for Industry: Computerized Systems Used in Clinical Trials; Availability

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Computerized Systems Used in Clinical Trials.'' The guidance document provides guidance for computerized systems used to create, modify, maintain, archive, retrieve, or transmit clinical data intended for submission to FDA. Whether collected or reported electronically or in paper form, clinical data must meet certain quality standards, and this guidance is intended to provide information on how computerized systems can meet these standards.

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