A second public consultation is now open on the Technical Specification (TS) of the ICH M11 Clinical Electronic Structured Harmonised Protocol. This aims to ensure clinical trials protocols follow a standardised format and can be electronically exchanged in a harmonised way across regulatory authorities. This is particularly useful for multi-centre and multi-national trials.

The updated TS incorporates refinements based on public feedback from the 2022 consultation and ongoing expert input. Stakeholders are invited to review and comment on the revised version until 22 April. Notably, the consultation focuses solely on the Technical Specification.

Find more details here