FDA and NIH Clinical Trial Protocol Template Documents Updated and Available for Public Comment

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FDA and NIH have updated the clinical trial protocol template for Phase 2 and Phase 3 IND (investigational new drug / investigational device exemption) studies.

Public comments can be submitted by April 17, 2016 via a form found on the NIH Office of Clinical Research and Bioethics Policy website under the Clinical Trial Protocol Template Documents section.

Download the protocol template shell here.

Download the instructions here.

Submit public comments on these new templates here.