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Research Study Regulatory Binder - PowerPoint PPT Presentation


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PURPOSE. The purpose of your regulatory binder should serve three-fold:Streamline work processes by compiling all study related documentation in one placeAllowing ease of access to most current documentation to all personnel with minimal effort A tool for monitoring regulations and standards set by federal departments (FDA, HHS, OHRP), your sponsor (NIH), and local regulatory bodies (IRB).

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