📄FDA Announces M11 Technical Specification for Clinical Trials
M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol; International Council for Harmonisation; Draft Technical Specification; and Template; Availability
Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of the revised draft technical specification entitled "M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol (CeSHarP)" and a supplemental document entitled "M11 Template." The revised draft technical specification and template were prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The revised draft technical specification recommends the use of an open, nonproprietary standard to enable electronic exchange of clinical protocol information. The template identifies headers, common text, and a set of data fields and terminologies that will be the basis for efficiencies in data exchange. These ICH documents 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. This revised draft technical specification and updated template revise and replace the draft versions of the same titles issued in December 2022.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The revised M11 Technical Specification establishes critical compliance requirements for clinical trial protocols, impacting businesses in pharmaceuticals and clinical research. The use of standardized protocol information fosters efficient regulatory submissions, enhancing the drug development process.