ICH M11 guideline, clinical study protocol template and technical specifications - Scientific guideline
HumanScientific guidelines
The purpose of this new harmonised guideline is to introduce the clinical protocol template and the technical specification to ensure that protocols are prepared in a consistent fashion and provided in a harmonised data exchange format acceptable to the regulatory authorities. The ICH M11 Clinical Electronic Structured Harmonised Protocol Template provides comprehensive clinical protocol organization with standardised content with both required and optional components. The Technical Specification (TS) that are acceptable to all regulatory authorities of the ICH regions presents the conformance, cardinality, and other technical attributes that enable the interoperable electronic exchange of protocol content with a view to develop an open, non-proprietary standard to enable electronic exchange of clinical protocol information.
Rationale for a second public consultation on the Technical Specification:
The ICH M11 Expert Working Group (EWG) has now completed the TS, incorporating the refinements needed to ensure its alignment with the updated template. This updated version of the template reflects public feedback from the 2022 consultation and additional input from the EWG’s ongoing work. A second public consultation on the TS is being conducted to provide the public with an opportunity to review and comment on the updated version.
Role of the M11 Protocol Template in supporting the second public consultation on the Technical Specification:
To assist with the review and public comment on the completed TS, the updated template is being provided as a reference document. It is important to emphasise that the purpose of this consultation is to seek public comment on the TS alone. The template is included solely to aid in the review and understanding of the TS and is not open for public comment during this consultation, as it was thoroughly reviewed during the 2022 public consultation period.
Keywords: protocol, harmonised template, interventional clinical trials, technical specification, data exchange, non proprietary standard