With a goal of facilitating the seamless exchange of clinical trial protocols, the International Council for Harmonization (ICH) has published draft recommendations for their structure and content.

The ICH M11 draft guideline provides general protocol design principles for sponsors, investigators, IRBs, regulatory agencies and other stakeholders through a template that promotes “consistency and efficiency in the development, amendment, review, conduct and closeout of a clinical trial and the exchange of protocol information.” The template was designed based on five principles:

• Building common core content;
• Serving the needs of stakeholders;
• Defining content for electronic exchange;
• Designing for content reuse; and
• Maintaining flexibility.

Per the guideline, ICH advises designing protocols with an eye for minimizing repetition and including essential information for trial conduct at the top. Similarly, the M11 guideline recommends that sponsors include trial-specific information in the main body of the protocol and reference/general details in an appendix section.

In addition to the template, the M11 guideline comes with a comprehensive technical specification document that goes in depth on the information that should be included for the various components of a protocol.

Access the M11 guidelines here: https://bit.ly/3TOKzua.

Access the M11 template here: https://bit.ly/3Neq088.

Access the M11 technical specifications here: https://bit.ly/3TXkQj0.