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GUIDANCE FINAL
M11 Clinical Electronic Structured Harmonised Protocol: Guidance Document, M11 Template, and Technical Specification Document
Published: 5/20/2026Detected: 5/23/2026

Summary preview

Establishes and harmonizes an M11 Clinical Electronic Structured Harmonised Protocol framework for structuring, submitting, and technically implementing clinical protocol information in an electronic, standardized…

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clinical
safety
labeling
quality
manufacturing
#clinical protocol
#electronic submission
#structured data
#ICH
#template

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