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Agent GCP and the Bloody Consent Form Manual and CD, Informed Consent and Institutional Review Boards in Clinical Trials, For Beginner to Advanced, For ... Also Relevant to Biomedical Ethics
Agent GCP and the Bloody Consent Form Manual and CD Informed Consent and Institutional Review Boards in Clinical Trials For Beginner to Advanced For Also Relevant to Biomedical Ethics Author:Daniel Farb, Bruce Gordon This 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. The manual accompanying the CD provides a copy of regulations. Agent GCP is THE way to learn FDA regulation... more »s. 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 any organization 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. You will need Internet access to e-mail us your unique key and receive a password key. License is for one user on one computer. An additional computer owned by the same user will generally be approved at the discretion of the publisher.« less