ICH M11 draft Guideline on Clinical electronic Structured Harmonised Protocol (CeSHarP), Technical Specification & Template bereiken Step 2 van het ICH proces

De International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) bracht op 22 oktober 2022 het nieuws dat de ICH M11 draft Guideline on Clinical electronic Structured Harmonised Protocol (CeSHarP), de Technical Specification en het Template op 27 september 2022 Stap 2 van het ICH proces hebben bereikt.

“This new guideline is proposed to provide comprehensive clinical protocol organisation with standardised 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.”

bron: ICH M11 ‘draft Guideline reaches Step 2 of the ICH process’ (21-10-2022)

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Guideline

• M11 Draft Guideline
• M11 Template
• M11 Technical Specification

Endorsed documents

• M11 Concept Paper
• M11 Business Plan
• M11 Work Plan