Clinical Trials in India, Africa, Asia
*Carolyn A. Carroll, Stat Tech, Inc. 

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Since the immediate neighborhood in which my class is being held has a "tent" village, I am particularly mindful of the ethical guidelines AND the difficulty of being certain that someone with little education truly understands the meaning of the information being conveyed in the informed consent document. Since informed consent documents and processes are a part of CDM, as an exercise I've asked my students to draft some examples in local languages for potential subjects with varying educational backgrounds. We will attempt at least a focus group facsimile via other students.