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UAB Policy on Use of and Investigation with Drugs, Biologics, Devices, or Test Articles under FDA Regulations - IRB POL021
Clinical investigations involving human subjects and drugs, biologics, devices or test articles are subject to review. In order to comply with federal regulations, the IRB will determine what types of applications and exemptions (when applicable) are required for the study. This document describes various types of studies and instructions for submission and compliance.
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