Final ICH M11 CeSHarP Guideline

The ICH M11 guideline, "Clinical Electronic Structured Harmonized Protocol (CeSHarP)", has been adopted and is now in the implementation phase.

Background

The new guideline outlines the general principles for developing the associated documents: the protocol template and the technical specification.

These documents are intended to assist stakeholders (i.e., those who use and exchange protocol information), including sponsors, investigators, investigator site staff, trial participants, institutional review boards/ethics committees, and regulators, in the development, amendment, review, conduct, and closeout of a clinical trial. Therefore,

• The protocol template presents the format and structure of the protocol, including the table of contents, common headers, and content instructions.
• The technical specification presents the data elements and technical attributes (e.g., definition, conformance, and cardinality) that enable the electronic exchange of interoperable protocol content.

More information is available on the ICH website under the Multidisciplinary Guidelines.