Agent GCP and the Bloody Consent Form Guidebook

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UniversityOfHealthCare, 2005 - Law - 332 pages
Agent GCP is THE way to learn FDA regulations. The exciting, suspenseful, and sometimes zany plot of a murder in a clinical trial is interweaved with interactivity and teaching of FDA regulations in an unforgettable manner. At the completion, learners will have obtained a superb knowledge of informed consent and IRB regulations. This course covers all the regulations on informed consent procedures and Institutional Review Boards (IRBs)—that is, Good Clinical Practices in 45 CFR 46, 21 CFR 50, 21 CFR 56, and other regulations. It is useful for any person or organization participating in clinical trials. The book contains useful aids including a glossary, a list of resources, model consent forms, and texts of regulations. Those readers who wish to have an accompanying program with interactivity should also purchase the CD version.

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About the author (2005)

M. DANIEL FARB, M.D., CEO of UniversityOfHealthCare and UniversityOfBusiness, is a leader in the field of interactive management and healthcare e-learning. He received a BA in English Literature from Yale (where he set an academic record and studied with writers like Robert Penn Warren), an M.D. from Boston University, a degree in Executive Management from the Anderson School of Business at UCLA, and is currently working on a degree at UCLA in International Trade. He is a practicing ophthalmologist. He also has received two patents in ophthalmology and is working on others, has worked with the World Health Organization in Geneva and the National Institutes of Health in Washington, D.C. He has written scientific and popular articles, and has worked as a newspaper reporter. He helped Dr. Robbins edit one of the editions of Robbins' "Pathology" textbook for readability. He wrote an article on humor for the Massachusetts Review. He has experience in theater and television, including acting, directing, and stage-managing. He has programmed his own patient records database. He has written and edited hundreds of e-learning courses. Dr. Farb is a member of the American Academy of Ophthalmology, the Union of American Physicians and Dentists, the AOJS, the American Association of Physicians and Surgeons, the American Society for Training and Development (ASTD), the E-Learning Forum, the Southern California Biomedical Council, the PDA (Parenteral Drug Association), and the Medical Marketing Association. BRUCE GORDON is the Creative Director for UniversityOfHealthCare. After receiving a BA in Economics from UCLA, he began a freelance writing career that included technical writing (such as a manual for Princess Cruise Lines), stand-up comedy routines for nationally known comedians, and screenplay writing. He has done production support work with famous Hollywood personalities on such well-known productions as Aaron Spelling's "Dynasty" and "Love Boat" TV shows. An audio-visual software specialist, he is a versatile artist, with published works in a variety of media, including music, motion graphics, and digital video short film.

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