FDA GUIDANCE · FINALMay 20, 2026

M11 Clinical Electronic Structured Harmonised Protocol: Guidance Document, M11 Template, and Technical Specification Document

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Guidance details are published by the U.S. FDA; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA. The authoritative text is on fda.gov.

Status

Final

Topic

ICH-Multidisciplinary

Issue date

May 20, 2026

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