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The study needs one is not really very complicated. The following steps will get you thru the process. 1. You must have a completed SUNY IRB application packet filled out for the study. Make sure that you go to the IRB website (http://www.upstate.edu/researchadmin/irb/), so that you are using the most current version of the application. This will serve as the protocol information for the FDA. 2. You must fill out an FDA form #1571 and form #1572 with information about the study, the Principal In.
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