Good Clinical Practice

Abstract

Good clinical practice (GCP) is an international quality standard that is provided by the International Council on Harmonization (ICH), an international body that defines standards, which governments can transpose into regulations for all phases of clinical trials involving human subjects. GCP applies to the trial sponsor team, the institutional review boards (IRB)/ethics committees (EC) and the investigator site teams. This chapter describes the GCP concepts, a GCP historical timeline, and how GCP in all phases of clinical trials and drug development through regulatory approval is the standard for clinical research.