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Getting Started
A
Guide for Investigators and Research Staff
What is research?
Research is defined by the DHHS Common Rule as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
The FDA defines research (or clinical investigation) as any experiment that involves a test article, one or more human subjects, and that is subject FDA regulations. Reflecting the regulatory purview of the FDA, test article refers to any drug for human use, biological product for human use, medical device for human use, human food additive, color additive, electronic product, or any other article subject to FDA regulations.
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