The FDA has issued a draft version of the International Council for Harmonization’s (ICH) M11 guideline, which provides sponsors with a standardized electronic protocol template, for public comment before publishing it as an officially implemented FDA final guidance.

The guideline covers the format, content and sharing of trial protocols, aiming to enable consistent, efficient exchange of protocol information between sponsors, sites, regulators, IRBs, ethics committees and other stakeholders.

It is based on five principles:

• Building common core content;
• Serving stakeholder needs;
• Defining content that will be electronically exchanged;
• Designing for content reuse; and
• Maintaining flexibility.

The template is designed to help sponsors and sponsor-investigators create protocols that are “complete, free from ambiguity, well-organized and aligned with quality-by-design principles” laid out in other ICH guidelines, M11 reads. The guideline also includes a lengthy technical specification document that recommends details to include for protocol components.

Comments on the draft guidance are due by Feb. 21.

Access the M11 draft guideline here: https://bit.ly/3C7QhRa.

Access the M11 template here: https://bit.ly/3Vw2iqu.

Access the M11 technical specifications here: https://bit.ly/3G3brkD.