Provide a solid knowledge base for conducting clinical research with human subjects. Includes two introductory courses on the FDA regulations. One session covers 21 CFR Parts 312 and 812, and the other covers 21 CFR Parts 50, 56, 54, and 11. It also includes a course comparing 21 CFR Parts 312 and 812.
Additionally, the Foundation Package includes good clinical practice with an overview of the history of clinical research. The Human Subjects Protection course reviews 21 CFR Part 50 in more detail as well as HIPAA in research. The Package also includes a course on our signature FAIR Shake(TM) technique, which teaches the learner to take an otherwise complicated maze of requirements and break them down into four simple areas that can be applied to solving clinical research questions.
The approximate time to complete each course and quiz is noted next to each course topic.