EMA - ICH Guideline and Template for Consultation

15th November 2022

ICH Guideline and Template for Consultation

• ICH M11 guideline (Step 2b):

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.

The purpose of this guideline is to describe the general protocol design principles and approach used to develop the separate associated documents, the ICH M11 Clinical Electronic Structured Harmonised Protocol Template and the Technical Specification that are acceptable to all regulatory authorities of the ICH regions. The Template presents the format and structure of the protocol, including the table of contents, common headers, and contents. The Technical Specification presents the conformance, cardinality, and other technical attributes that enable the interoperable electronic exchange of protocol content.

• ICH M11 technical specification (Step 2b):

The purpose of this document is to serve as a technical representation of the ICH M11 protocol template. This Technical Specification 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.

• ICH M11 template (Step 2b):

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. Existing ICH Guidelines and ISO 14155 were considered in its development. The template is designed to enable modification suitable for the particular trial. Refer to the sections below for additional details and conventions related to flexibility.

Comments should be provided using this  template and sent to ich@ema.europa.eu by 26 February 2023.

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