ICH M11: CeSHarP

At the Kobe meeting in June 2018, the ICH (International Council for Harmonization) Assembly agreed on the establishment of informal working groups to finalize concept papers and develop business plans on three new topics for ICH harmonization (ICH Q13, ICH Q14, ICH M11). One of the working groups will cover the topic of ICH M11 "Clinical electronic Structured Harmonized Protocol (CeSHarP)".

The new topic was proposed to ICH by the PhRMA (Pharmaceutical Research and Manufacturers of America), the trade group representing companies in the pharmaceutical industry in the United States, in December 2017. Work will now begin on developing formal concept papers and work plans.

The new M11 topic will deal with the establishment of detailed electronic standards for clinical study protocols for use in electronic Common Clinical Trial Submissions (eCCTS). The work is part of the ICH M2 "ESTRI Electronic Standards for the Transfer of Regulatory Information" EWG Work Plan (which includes also the e-Trial Master File metadata harmonization (eTMF)).

Additionally, the revision of the Q&As for the electronic submission of Individual Case Study Reports, eICSRs, (E2B(R3)) has been adopted by the Assembly at the Kobe meeting (Step 4 of the ICH process).

For more details on the scope of these new harmonization activities please visit the ICH website.