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The International Council for Harmonisation (ICH) has released a draft guideline which outlines a harmonized template for clinical trial protocols to support consistent reporting among sponsors. The ...

The International Council for Harmonisation (ICH) announced plans to develop two new guidelines on 26 November. One will focus on the use of real-world evidence (RWE) to inform regulatory ...

The International Council for Harmonisation (ICH) M11 Expert Working Group (EWG) (Clinical electronic Structured Harmonized Protocol (CeSHarP) has developed a clinical protocol template and technical ...

HL7 Vulcan and CDISC are announcing a project that will deliver an electronic exchange standard for the ICH M11 Clinical electronic Structured Harmonised Protocol (CeSHarP) “The project marks an ...

HL7 Vulcan and CDISC are announcing a project that will deliver an electronic exchange standard for the ICH M11 Clinical electronic Structured Harmonised Protocol (CeSHarP) A structured, harmonized, ...