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# Clinical Electronic Structured Protocol Template
- URL: https://www.fdaweb.com/clinical-electronic-structured-protocol-template/
- Published: 2026-05-21T12:00:00.000Z
- Updated: 2026-09-14T13:39:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161183

FDA has published the International Council for Harmonization (ICH) *M11 Template: Clinical Electronic Structured Harmonized Protocol*, which is intended for interventional clinical trial protocols and is said to be suitable for all phases and therapeutic areas of clinical research. The [document](https://www.fda.gov/media/164117/download?ref=fdaweb.com) is marked “For Reference Only.” It says that existing ICH guidances were considered during the development of the template.