The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS

Origin/Publisher:

FDA

Document Type:
GUIDANCE FOR INDUSTRY
Content:
This document addresses issues pertaining to computerized systems used to create, modify, maintain, archive, retrieve, or transmit clinical data intended for submission to the Food and Drug Administration (FDA).

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