Regulatory & Documentation
ICH M11 (Common Protocol Template)
ICH M11 is the international harmonized standard, published by the International Council for Harmonisation, that defines a Common Protocol Template (CPT) and machine-readable Technical Specification for clinical trial protocols.
M11 standardizes section ordering, headings, and key data elements across protocols globally, enabling automated downstream document generation (ICFs, SAPs, CSRs), regulatory submission interoperability, and cross-trial analytics. Regulators including FDA, EMA, and PMDA have published implementation roadmaps; FDA has signalled M11 alignment as a 2025; 2026 expectation.
Adopting M11 manually is non-trivial because legacy protocol templates rarely map 1:1. AI-assisted protocol tooling (Kitsa KScribe) supports both legacy and M11-structured outputs from a single source, easing the transition.
Related terms
Clinical Trial Protocol
A clinical trial protocol is the master document that defines a clinical study's objectives, design, methodology, statistical considerations, and operational conduct, and that all investigators must follow to ensure scientific validity and participant safety.
Good Clinical Practice (GCP)
Good Clinical Practice (GCP) is the international ethical and scientific quality standard, codified in ICH E6, for designing, conducting, recording, and reporting clinical trials that involve human participants.
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