M11 Clinical Electronic Structured Protocol

FDA has published the International Council for Harmonization (ICH) M11 Guideline, M11 Electronic Structured Harmonized Protocol, describing the processes and procedures directing the conduct and analysis of a clinical trial of medicinal products in humans. The document says that to date no internationally adopted harmonized standard has been established for the format and content of the clinical protocol to support consistently across sponsors and for the electronic exchange of protocol information.

“Variability in format and core content among sponsors contributes to inefficiencies and difficulties in searching, reviewing, and assessing clinical trial protocols,” the guidance says. “Use of the clinical trial protocol template aids the sponsor or sponsor-investigator in the development of a protocol that is complete, free from ambiguity, well organized, and aligned with quality by design principles as set forth in other ICH guidelines.”

FDA also published with the guideline a template and technical specifications.