GxP is a general term used to represent the FDA regulations governing Good Clinical Practice, Good Laboratory Practice, Good Manufacturing Practice, as well as Electronic Records and Electronic Signatures.
GxP Compliance refers to the compliance of the many processes implemented and executed as part of the research practices that are subject to these regulations.
The conduct of FDA-regulated human subject research at the University involves the complex interaction of many federal and state regulations as well as internal institutional policies that govern human subject research.
