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Good Clinical Practice (GCP): FDA-regulated Clinical Trials

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.  Many countries have adopted GCP principles as laws and/or regulations.  The Food and Drug Administration’s (FDA’s) regulations for the conduct of clinical trials, which have been in effect since the 1970s, address both GCP and HSP.  These FDA regulations and guidance documents are accessible from the FDA web site.  International GCP Guidance documents on which FDA has collaborated and that have been adopted as official FDA guidance are also available.