ICH M11 Expert Working Group Issues Final Presentation for Clinical Trial Protocol Standardisation

International Council for Harmonisation announced on May 12, 2026, that the ICH M11 Expert Working Group issued a final overview presentation at Step 4 of the ICH harmonisation process for ICH M11: The Clinical electronic Structured Harmonised Protocol (CeSHarP).

The guideline was adopted in November 2025.

About ICH M11

ICH M11 is a comprehensive guideline consists of three interconnected document that together standardise clinical trial protocol format, content, and exchange.

The three documents are:

• A harmonised guideline
• A clinical trial protocol template
• A technical specification to enable electronic exchange of protocol contents

Scope of Application

The documents apply to interventional clinical trials of medicinal products across:

• all phases
• all therapeutic areas

The announcement states that the scope includes:

• Pharmaceuticals
• Biologics
• Vaccines
• Drug-device combinations
• Cell or gene therapy products

Purpose of the Guideline

Prior to ICH M11 there was no globally harmonised standard for clinical trial protocol format and content.

This resulted in significant variability across trial sponsors and regions.

According to ICH, implementation of a common template and technical specification for clinical trial protocols will:

• Reduce inefficiencies
• Reduce difficulties in searching and reviewing protocols
• Allow electronic protocol exchange using an interoperable standard

Additional Resources

• The Step 4 overview presentation for ICH M11
• ICH M11 CeSHarP and associated documents
• The updated page on Electronic Standards for the Transfer of Regulatory Information (ESTRI)

For more information: ICH M11 Expert Working Group issues final overview presentation

Supporting Clinical Trial Documentation Processes

Standardised protocol structures and electronic exchange systems continue to support clinical research documentation and regulatory coordination activities.

Baupharma’s Clinical Research services support companies in clinical trial documentation and clinical operations activities.