In a recently released draft guidance document, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) describes general protocol design principles and approaches used to develop relevant documents for clinical trial sponsors, investigators, Institutional Review Boards (IRBs) and regulatory agencies.
The ICH explains in its Sept. 27 draft, “Clinical Electronic Structured Harmonised Protocol (CeSHarP),” that to date, “no internationally adopted harmonized standard has been established for the format and content of the clinical protocol to support consistency across sponsors and for the electronic exchange of protocol information.” The draft is expected to be used for clinical trials across various industries, including medical devices.
The M11 draft guidance further describes a clinical trial protocol template that can be used to aid sponsors, investigators, and other stakeholders in the “development of a protocol that is complete, free from ambiguity, well organized, and aligned with quality by design principles as set forth in other ICH guidelines.”
The draft goes on: “A protocol template is intended to provide value to parties that include sponsors, investigators, clinical site personnel, trial participants, ethics committees, and regulators.”
More information from the ICH on the protocol template can be found in a separate Sept. 27 draft guideline, found here.
The ICH says in its M11 document that the template was designed “based on general principles that would support a harmonized standard protocol to facilitate consistency and efficiency in the development, amendment, review, conduct and closeout of a clinical trial and the exchange of protocol information.”
Those general principles include:
- Building common-core content;
- Serving the needs of stakeholders;
- Defining content for electronic exchange;
- Designing for content reuse; and
- Maintaining flexibility.
Along with the draft guidance and draft template guideline document, a 344-page technical specification doc was also released with the goal of harmonizing essential information to be included in the protocol, including trial-specific information, while minimizing repetitions, variability in format, and core content.
As with the guidance, the draft template guideline and the tech specs are expected to be used across all types of clinical trials across various industries.
The ICH M11 draft is one of 15 ICH multidisciplinary guidances that don’t fit into one of the group’s Quality, Safety and Efficacy categories.
Areas and countries that are regulatory members of ICH include Europe, the U.S., Japan, Canada, Switzerland, Brazil, Mexico, Singapore, South Korea, U.K., China, Saudi Arabia, Chinese Taipei, and Turkey.
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