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FDA (CDER)
GUIDANCE DRAFT
M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol
Published: 6/6/2025Detected: 3/20/2026

Summary preview

Defines a draft M11 technical specification for clinical electronic structured harmonised protocol representations, which may change how clinical trial protocols are authored, structured, and exchanged for regulatory…

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clinical
safety
labeling
quality
manufacturing
#clinical electronic protocol
#structured protocol
#harmonised representation
#regulatory submissions
#FDA CDER

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