Federal Register #FDA-2022-D-3054

FDA Issues Final Guidance on M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP)

This announcement from the Food and Drug Administration (FDA) provides industry stakeholders with final guidance on the M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP): - Issued by the FDA, part of the Department of Health and Human Services - Developed under the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) - Guidance package includes: - Guidance document outlining recommendations for digital clinical trial protocols - Standardized protocol template for harmonized content and structure - Technical specification document detailing data fields and electronic exchange standards - Aims to standardize and harmonize the structure, terminology, and data exchange for clinical trial protocols internationally - No procurement, products, part numbers, or purchase quantities are requested - No vendors or OEMs are involved; this is an informational notice only

Description

The Food and Drug Administration (FDA) announces the availability of a final guidance for industry entitled "M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP)." This guidance, prepared under the International Council for Harmonisation (ICH), includes a guidance document, a template, and a technical specification document. It provides rationale and recommendations for implementing a harmonized digital clinical trial protocol with standardized content and formatting to facilitate electronic exchange of clinical protocol information. The guidance aims to create an internationally harmonized standard to aid regulators, sponsors, ethical oversight bodies, investigators, and other stakeholders in reviewing and assessing clinical trial protocols.

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