CLR 560 - GXPs, ICH, and Quality Audits

Credits: 3

In-depth study of regulations governing the design and execution of clinical research. The role of IRBs, history of GXPs, principals of GLPs, GMPs, and GCPs are reviewed. The incorporation of compliance and quality assurance in clinical research, as well as auditing strategies, compliance inspections and auditing techniques reviewed.

Click here for the Spring 2025 Class Schedule.