FDA Clinical Trials and Human Subject Protection

Adherence to the principles of good clinical practices (GCPs), including adequate human subject protection (HSP) is universally recognized as a critical requirement to the conduct of research involving human subjects.  The Food and Drug Administration’s (FDA’s) regulations for the conduct of clinical trials address both GCP and HSP.  FDA regulations and guidance documents are accessible from this site as well as international GCP guidance documents on which FDA has collaborated and that have been adopted as official FDA guidance.

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