Overview

This book 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 modularised 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 organisation conducting clinical trials or informed consent outside of a clinical trial. The estimated time for this program is 15-20 hours.

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9781594910326

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