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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. Subjects are modularized so that learners can take one subject out of sequence should they need to. At the completion, learners will have obtained a superb knowledge of informed consent and IRB regulations. This course consists of 9 smaller courses and a final exam and covers all the regulations on informed consent procedures and Institutional Review Boards (IRBs)--that is, the regulations of Good Clinical Practices in 45 CFR 46, 21 CFR 50, 21 CFR 56, and other regulations. It is useful for anyone conducting clinical trials or informed consent outside of a clinical trial. Time estimate: 15-20 hours. 826 pages on CD. 67 pages in the manual. For convenience, the CD and the manual contain the text of relevant regulations. You must have Internet Explorer 4.0 or higher running on your computer. Supported operating systems are Windows 95, 98, 98 SE, ME, 2000, or XP. The CD is licensed to play once on any Windows computer; the borrower may purchase the program after that. One library reference activation is included in the price.
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4 star review from Foreword Reviews: The discovery, after World War II, of the Nazi doctors’ shocking experimentation on people caused the United States to pass laws requiring the ethical treatment of human subjects during experiments. This CD with accompanying manual is meant to teach doctors these laws.
UniversityofHealthCare is a company devoted to designing training CDs for health professionals. Dr. Farb provides the medical expertise. Mr. Gordon’s experience in writing stand-up routines for nationally known comics, and doing production work on "Dynasty" and "Love Boat," is evident throughout the CD.
The CD contains ten lessons, or "episodes." They are called episodes because each one advances the story of Dr. Michelle Coquette, the Director of Clinical Trials for Oncophrenics Pharmaceutical Corporation. Michelle, with the help of Agent GCP, discovers that there are problems with her company’s testing of its new antidepressant drug, Cheerasil. An informed consent form with blood on it is a tip-off that the researchers are not following proper procedures when obtaining consent from the study subjects.
The plot is skimpy, but it keeps the reader interested in learning the laws. The CD is a surprisingly fast and lively read. In addition to resembling an episode on a television show, each lesson is like a game show. Worked into the lessons are multiple choice questions about the laws. The questions are constructed in a fun way; there is usually one humorous wrong answer. It is entertaining to be able to interact with the computer. It makes it more likely that the reader will finish all the lessons and, hence, learn the laws.
The CD’s clip art and pictures are a little raw, but this adds to the zany game show effect. Michelle is presented in a way that could be construed as sexist. She has to flirt with the computers to get them to help her. Female readers may be annoyed by this, but it does add to the overall TV-show motif.
This CD is an entertaining way for doctors, pharmaceutical company scientists, and other researchers to learn about the laws governing such issues as informed consent and the role of Institutional Review Boards (IRBs) in clinical research.About the Author:
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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Book Description University Of Health Care, 2004. Paperback. Condition: New. Seller Inventory # DADAX1594910324
Book Description University Of Health Care, 2004. Condition: New. book. Seller Inventory # M1594910324
Book Description University Of Health Care, 2004. Paperback. Condition: New. Ships with Tracking Number! INTERNATIONAL WORLDWIDE Shipping available. Buy with confidence, excellent customer service!. Seller Inventory # 1594910324n