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# Clinical Trial Protocol Template Finalized
- URL: https://www.fdaweb.com/clinical-trial-protocol-template-finalized/
- Published: 2017-05-02T12:00:00.000Z
- Updated: 2026-09-14T22:21:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138598

CBER director **Peter Marks** says FDA and the National Institutes of Health have released a finalized [template ](http://osp.od.nih.gov/office-clinical-research-and-bioethics-policy/clinical-research-policy/clinical-trials?ref=fdaweb.com)for investigators to use when organizing clinical trial protocols. Writing in an *FDA Voice* blog post, Marks says issuance of the template “is likely to contribute important efficiencies to the process of protocol development, saving medical product development time and money.”

The final version is intended for clinical investigators who are writing protocols for Phase 2 and 3 NIH-funded studies requiring IND or IDE applications. He says it also could be helpful to other investigators conducting studies of medical products not regulated by FDA. It provides both instructional and sample text and reflects input from the public through nearly 200 comments from over 60 individuals. It was harmonized, Marks writes, with a separate protocol template recently developed by the private sector Transcelerate Biopharma for industry-sponsored research.

“Having a standard protocol format will facilitate review of protocols by regulators and others,” Marks says. “We believe that the template will help investigators prepare protocols that are consistent and well-organized, contain all the information necessary for the clinical trial to be properly reviewed, and follow the International Conference on Harmonization E6 good clinical practice guidelines.”