M11 Clinical electronic Structured Harmonised Protocol (CeSHarP)
M11 EWG Clinical electronic Structured Harmonised Protocol (CeSHarP)
This topic was endorsed by the ICH Management Committee in November 2018. This new guideline is proposed to provide comprehensive clinical protocol organization with standardised content, with both required and optional components. The guideline will outline two main sets of harmonised approaches:
a template to include identification of headers, common text and a set of data fields and terminologies which will be the basis for efficiencies in data exchange,
a technical specification that uses an open, non-proprietary standard to enable electronic exchange of clinical protocol information.
Endorsed Documents (Click the links below for complete guidelines)
*These Guidelines Belongs to ICH website.
