ICH M11 Draft Guideline Reaches Step 2

On 21 October 2022 the ICH announced the ICH M11 draft guidelines reached step 2 of the ICH process.

This new guideline is proposed to provide comprehensive clinical protocol organization with standardized content, with: a Template which presents the format and structure of the protocol, including the table of contents, common headers, and contents; and a Technical Specification which presents the conformance, cardinality, and other technical attributes that enable the interoperable electronic exchange of protocol content.

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