There is currently no internationally accepted, harmonized guidance or template for the format and content of clinical trial protocols. As a result, inconsistencies in content and structure among clinical protocols submitted to regulatory agencies complicate the review process, extend review timelines, increase the need for protocol amendments, delay study activations, and ultimately slow down drug development and patient access to new treatments. To address these difficulties, the International Council for Harmonisation (ICH) is developing a new harmonized guideline for clinical protocols, the Clinical electronic Structured Harmonised Protocol (CeSHarP), also called ICH M11. Want to learn more? The full article can be found here: https://lnkd.in/eUAW_q8Z