FDA publishes new M11 technical specification for electronic harmonized clinical protocols (CeSHarP)
The FDA has released the new version of the M11 Technical Specification, which accompanies the development of the structured and harmonized electronic clinical protocol (CeSHarP) in the context of the international harmonization process (ICH M11). This document represents an essential step towards the digitization and global standardization of clinical trial protocols.
What is CeSHarP?
CeSHarP is an electronic clinical protocol model with a standardized structure, developed within the framework of the ICH:
Facilitate the electronic exchange of data between sponsors, CROs and regulatory authorities;
Reduce redundancies and inconsistencies in protocol documents;
Streamlining the regulatory submission, review and approval processes.
What does this new specification contain?
The M11 Technical Specification details all the structural components, variables, data types, compliance rules and content reuse that must be followed when building a harmonized clinical protocol. It is organized into elements such as:
Identification of the trial (title, phase, sponsor, versions);
Investigational products (codes, names, manufacturer);
Regulatory data (IND, IDE, CT, NCT numbers, etc.);
Hierarchical structure of elements (TOC, cardinality, reuse).
Impact for sponsors and manufacturers
This initiative represents a significant step forward in the international interoperability of clinical data:
Reduction of errors and rework;
Speeding up the submission and review processes;
Compatibility with global electronic systems (e.g. CTIS, CDISC).
In practice, medical device manufacturers promoting clinical trials or collaborating with CROs should start adapting their clinical protocols to this new electronic structure, ensuring that they comply with the emerging requirements of the different regulatory markets, such as the FDA, EMA and PMDA.
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