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5/15/17 – FDA, NIH issue final trial protocol

FDA and NIH have issued the final version of a clinical trial protocol template for phase 2 and phase 3 NIH-funded studies requiring investigational new drug or investigational device exemption applications. A standard protocol format will facilitate protocol review by regulators and others (e.g., institutional review boards) and will help investigators prepare protocols that are consistent and well organized according to the International Conference on Harmonisation (ICH) E6 Good Clinical Practice guidelines.

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