This course provides an introduction to Good Clinical Practice (GCP) in clinical research according to International Conference on Harmonisation (ICH) Guidelines and also US Food and Drug Administration (FDA) regulations. Topics include: conducting clinical trials in accordance with GCP; regulations established by international regulatory bodies; the roles and responsibilities of investigators and sponsors; protection of human subjects by obtaining informed consent; the composition and responsibilities of the Institutional Review Board (IRB), IRB review process; Standard Operating Procedures (SOPs) at the study site; compliance and accountability during a clinical trial; protocol violations and deviations; and GCP consequences.