Recently on 21-December-2022, U.S Food and Drug Administration announced the availability of a draft guidance for industry entitled “M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP),” and two supplemental documents entitled “M11 Template” and “M11 Technical Specification”.
The draft guidance provides recommendations for a harmonized clinical trial protocol including the organization of standardized content and formatting.
The draft template identifies headers, common text, and a set of data fields and terminologies that will be the basis for efficiencies in data exchange.
The technical specification recommends the use of an open, non-proprietary standard to enable electronic exchange of clinical protocol information.
The purpose of the draft guidance and the supporting documents is to create an international standard for the content and exchange of clinical trial protocol information facilitating review and assessment by regulators, sponsors, ethical oversight bodies, investigators, and other stakeholders.
The clinical protocol describes the processes and procedures directing the conduct and analysis of a clinical trial of medicinal product(s) in humans. To date, no internationally adopted harmonised standard has been established for the format and content of the clinical protocol to support consistency across sponsors and for the electronic exchange of protocol information.
This template is intended for interventional clinical trials of drugs, vaccines, and drug/device combinations intended to be registered as drugs. The template is suitable for all phases of clinical research and all therapeutic areas. The template is designed to enable modification suitable for the particular trial.
The purpose of this document is to serve as a technical representation of the ICH M11 protocol template. This Technical Specification (TS) is to be aligned with the latest version of the ICH M11 Guideline and protocol template, but with flexibility in addressing data exchange needs per ICH and those of regional authorities.