This topic was endorsed by the ICH Management Committee in November 2018. This new guideline is proposed to provide comprehensive clinical protocol organisation with standardised content, with:
- A Template which presents the format and structure of the protocol, including the table of contents, common headers, and contents;
- A Technical Specification which presents the conformance, cardinality, and other technical attributes that enable the interoperable electronic exchange of protocol content.
The Technical Specification document and Template had reached Step 2b on 27 September 2022 and entered public consultation. They have been updated by the M11 EWG following the comments received. The Technical Specification is now being submitted for a second round of public consultations, and the Template is provided as a support to the consultation.
