Agent GCP and the Bloody Consent Form 5 Users: Informed Consent and Institutional Review Boards in Clinical Trials, For Beginner to Advanced, For ... Also Relevant to Biomedical Ethics

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. 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 any organization conducting clinical trials or informed consent outside of a clinical trial. Time estimate: 15-20 hours. 826 pages. For convenience, the CD contains the text of some of the 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. The multiuser CDs are designed for organizations that wish to train and test a number of people at a discounted price and retain the information in the course for future reference. Each user who passes successfully with a score of 80 may print a certificate of completion. Each CD may only be activated on one computer and contains tests for up to the number specificed in the title.