Zdrowie i gospodarka · 18/06/1997

Draft Guidance for Industry: Computerized Systems Used in Clinical Trials; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled ``Guidance for Industry: Computerized Systems Used in Clinical Trials.'' The draft guidance document addresses issues pertaining to computer systems used to generate, collect, maintain, and transmit clinical data intended for submission to FDA in support of marketing or research applications. The data, whether collected or reported electronically or in paper form, must meet certain quality standards, and this draft guidance document is intended to provide information on how these standards might be met by computerized systems.