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A set of 52 cards containing questions and answers about the FDA Regulations relating to consent and ethics, investigator responsibilities and Form FDA 1572. The questions are based on 21 CFR Parts 50 and 56 (current on the FDA website May 2011, FDA Guidance on Investigator Responsibilities (October 2009) and FDA Guidance on Form FDA 1572 (May 2010). Still current May 2014.
Ideal for anyone needing to learn or brush up their skills on the FDA regulations.
A complementary set (Part 1) provides even more questions.