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ISBN: 1932634630Издательство: UniversityOfHealthCare
Год издания: 2003
Book DescriptionThis title is part of the UniversityOfHealthCare/ UniversityOfBusiness Interactive Training Library, which offers authoritative, clearly written material in an interactive form for better comprehension and documentation of completion. Themanual accompanying the CD provides a copy of regulations. 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 regulationsin 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...