Book Description

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.