Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP)," and two supplemental documents entitled "M11 Template," and "M11 Technical Specification." The draft guidance, template, and technical specification were prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonisation. The draft guidance provides recommendations for a harmonized clinical trial protocol including the organization of standardized content and formatting. The draft template identifies headers, common text, and a set of data fields and terminologies that will be the basis for efficiencies in data exchange. The technical specification recommends the use of an open, non-proprietary standard to enable electronic exchange of clinical protocol information. The intent of the draft guidance and supporting documents is to create an international standard for the content and exchange of clinical trial protocol information facilitating review and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.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2022-D-3054] AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP),” and two supplemental documents entitled “M11 Template,” and “M11 Technical Specification.” The draft guidance, template, and technical specification were prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonisation. The draft guidance provides recommendations for a harmonized clinical trial protocol including the organization of standardized content and formatting. The draft template identifies headers, common text, and a set of data fields and terminologies that will be the basis for efficiencies in data exchange. The technical specification recommends the use of an open, non-proprietary standard to enable electronic exchange of clinical protocol information. The intent of the draft guidance and supporting documents is to create an international standard for the content and exchange of clinical trial protocol information facilitating review and assessment by regulators, sponsors, ( printed page 78697) ethical oversight bodies, investigators,…
Other Federal Register documents from the same docket.
M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP); International Council for Harmonisation; Guidance for Industry; Availability
M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol; International Council for Harmonisation; Draft Technical Specification; and Template; Availability
Citation: 87 FR 78696
