Good Clinical Practice and Good Laboratory Practice

Clinical and laboratory data used in national regulatory decisions are legally mandated to meet the written specification detailed under the rubric of “Good Clinical Practice” and “Good Laboratory Practice” (GLP). This chapter is written in two distinct sections that distinguish the two disciplines supporting clinical investigation: the first section “Good Clinical Practice” is written to advise the clinician investigator; it is based on the 1996 International Conference on Harmonization guidelines and incorporates the National Institute of Health regulations as well as Food and Drug Administration (FDA) regulations and guidance documents. The second section “Good Laboratory Practice” is written for the laboratory director with emphasis on specialized laboratory services that have not yet been incorporated into routine clinical practice. It is based on the FDA regulations for GLPs.