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Clinical trials computer guidance needs clarification, HIMA tells FDA.

This article was originally published in The Gray Sheet

Executive Summary

GUIDANCE ON COMPUTERIZED SYSTEMS IN CLINICAL TRIALS NEEDS CLARIFICATION, HIMA SAYS in Nov. 3 comments to FDA. Asking FDA to better define the scope of the policy, the Health Manufacturers Association says it "seems appropriate for data entry systems" but not for a "computer program that communicates" with a device or devices "to gather data and deposit it into a database automatically."
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