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# FDA, NIH Developing Template for Phase 2-3 Protocols
- URL: https://www.fdaweb.com/fda-nih-developing-template-for-phase-2-3-protocols/
- Published: 2016-03-18T12:00:00.000Z
- Updated: 2026-09-14T20:50:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135132

> FDA and the National Institutes of Health (NIH) are [developing a template](http://blogs.fda.gov/fdavoice/index.php/2016/03/fda-and-nih-release-a-draft-clinical-trial-protocol-template-for-public-comment/?ref=fdaweb.com) with instructional and sample text for NIH-funded investigators to use when writing protocols for Phase 2 or 3 clinical trials that require IND or IDE submissions. Their goal is to make it easier for investigators to prepare protocols that are consistently organized and contain all necessary information proposed trials to be properly reviewed. The draft template follows International Conference on Harmonization E6 Good Clinical Practice standards. The agencies are seeking comments and feedback on the template, particularly perspectives on the utility of such a template and whether the instructional and sample text is clear and readable.