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 draft guideline, as well as the template and specifications for the template, were endorsed by the ICH Assembly on 27 September and released for public consultation on 21 October.
The guideline aims to have clinical trial protocol templates that are “complete, free from ambiguity, well organised, and aligned with quality by design principles as set forth in other ICH guidelines.”


The purpose of this guideline is to describe the general protocol design principles and approach  used to develop the separate associated documents, the ICH M11 Clinical Electronic Structured  Harmonised Protocol Template [Template] and the Technical Specification that are acceptable to  all regulatory authorities of the ICH regions. The Template presents the format and structure of the  protocol, including the table of contents, common headers, and contents. The Technical  Specification presents the conformance, cardinality, and other technical attributes that enable the  interoperable electronic exchange of protocol content.