The report of the public webinar on “ICH M11: Clinical electronic Structured Harmonised Protocol (CeSHarP),” organized by the International Council for Harmonisation (ICH) and convened by the Clinical Trials Transformation Initiative (CTTI), is now available. More than 1,700 people registered for the webinar, which was held on January 26, 2023. 

The ICH M11 Expert Working Group (EWG) members, who are updating the guideline, explained the benefits and opportunities that will be created for stakeholders with the electronic exchange capabilities of an internationally harmonised structured protocol template. The EWG members presented an overview of the M11 Guideline and the associated protocol template and technical specification. In closing, EWG members answered common questions that were submitted by participants during the registration process. 

View the recording and slide deck of the webinar to learn more. 

For additional information on the ICH M11 Guideline, please see the ICH Guidelines site, M11 Draft Guideline, M11 Template, and M11 Technical Specification.