GUIDELINE
ICH M11 Clinical Electronic Structured Harmonised Protocol Final Guidance
ABSTRACT — EDITORS' SUMMARY
Provides final ICH guidance for a harmonized digital clinical trial protocol, including a standardized template and technical specification for electronic exchange. Aims to create an internationally harmonized standard for protocol content and exchange to facilitate review by regulators, sponsors, ethics committees, and investigators.
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PDF · CANONICAL LINK http://www.fda.gov/regulatory-information/search-fda-guidance-documents/m11-clinical-electronic-structured-harmonised-protocol ↗ RELATED · SAME AUTHORITY