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M11 Template: Clinical Electronic Structured Harmonised Protocol December 2022


Not for implementation. Contains non-binding recommendations.

Docket Number:
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research, Office of Regulatory Policy

This template is intended for interventional clinical trials of drugs, vaccines, and drug/device combinations intended to be registered as drugs. The template is suitable for all phases of clinical research and all therapeutic areas. Existing ICH Guidelines and ISO 14155 were considered in its development. The template is designed to enable modification suitable for the particular trial. Refer to the sections below for additional details and conventions related to flexibility.

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2022-D-3054.

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