Do you know why rules, regulations and standards exist? What exactly is Good Clinical Practice and how does this help protect patients and data integrity?

The key players in a clinical investigation are infamously made up of Sponsors, monitors, investigative sites, and patients.  A fundamental part of the team is also the Institutional Review Board (IRB), as they oversee the conduct of clinical research. Per the FDA’s IRB information sheet, “IRBs are responsible for continuing review of ongoing research to ensure that the rights and welfare of human subjects are protected.” That’s a tall order!