ICH M11 guideline, clinical study protocol template and technical specifications - Scientific guideline

The purpose of this new harmonised guideline is to introduce the clinical protocol template and the technical specification to ensure that protocols are prepared in a consistent fashion and provided in a harmonised data exchange format acceptable to the regulatory authorities. The ICH M11 Clinical Electronic Structured Harmonised Protocol Template provides comprehensive clinical protocol organization with standardized content with both required and optional components. The Technical Specification that are acceptable to all regulatory authorities of the ICH regions presents the conformance, cardinality, and other technical attributes that enable the interoperable electronic exchange of protocol content with a view to develop an open, non-proprietary standard to enable electronic exchange of clinical protocol information.

Keywords: protocol, harmonised template, interventional clinical trials, technical specification, data exchange, non proprietary standard

Current version

ICH M11 guideline, clinical study protocol template and technical specifications - Step 2b

Consultation dates: 26/10/2022 to 26/02/2023 Draft: consultation closed Reference Number: EMA/CHMP/ICH/778799/2022

English (EN) (770.99 KB - PDF)

Overview of comments received on ICH M11 guideline, clinical study protocol template and technical specifications

English (EN) (232.11 KB - PDF)

ICH M11 technical specification - Step 2b

Consultation dates: 26/10/2022 to 26/02/2023 Draft: consultation closed Reference Number: EMA/CHMP/ICH/778800/2022

English (EN) (3.05 MB - PDF)

Overview of comments received on ICH M11 technical specification

English (EN) (168.48 KB - PDF)

ICH M11 template - Step 2b

Consultation dates: 26/10/2022 to 26/02/2023 Draft: consultation closed Reference Number: EMA/CHMP/ICH/778801/2022

English (EN) (1.1 MB - PDF)

Overview of comments received on ICH M11 template

English (EN) (1.21 MB - PDF)