US EditionSecond public consultation on the ICH M11 Technical Specification - Fondazione Gianni Benzi Onlus
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Second public consultation on the ICH M11 Technical Specification - Fondazione Gianni Benzi Onlus
A second public consultation is now open on the Technical Specification (TS) of the ICH M11 Clinical Electronic Structured Harmonised Protocol. This aims to ensure clinical trials protocols follow a standardised format and can be electronically exchanged in a harmonised way across regulatory authorities. This is particularly useful for multi-centre and multi-national trials. The updated TS incorporates refinements based on public feedback from t…
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