A Clinical Trials Manual from the Duke Clinical Research Institute: Lessons From A Horse Named Jim

A comprehensive guide to conducting clinical trials. The text provides historical context for regulatory development, citing events like the contaminated diphtheria antitoxin from a horse named Jim and the thalidomide tragedy, which led to significant legislation. It details the practical aspects of running a clinical trial at an investigative site, covering topics such as the management of study documents, the rigorous processes for handling investigational drugs and devices, and the necessary procedures for study start-up and close-out. Furthermore, the manual outlines the ethical and regulatory framework governing research, emphasizing the principles of Good Clinical Practice (GCP), the role of the Institutional Review Board (IRB), the detailed requirements for informed consent, and the mandatory processes for adverse event reporting and data management.You can listen and download our episodes for free on more than 10 different platforms:https://linktr.ee/pharmacy_simpleProduced by:https://www.podcaistudio.com/