The International Council for Harmonisation (ICH) M11 Expert Working Group (EWG) (Clinical electronic Structured Harmonized Protocol (CeSHarP) has developed a clinical protocol template and technical specification to ensure clinical study protocols are prepared in a consistent manner and provided to users in a harmonised data exchange format acceptable to all regulatory authorities of the ICH regions. This protocol and electronic exchange format will facilitate the streamlining and exchange of protocol information and support future tool development.
ICH and CDISC (Clinical Data Interchange Standards Consortium) have signed a Memorandum of Understanding (MOU) collaborating to support the maintenance and governance of ICH M11 controlled terminology. This collaboration focuses on the use of CDISC’s unified governance process and terminology services for the long-term support of ICH M11 controlled terminologies and focuses on the curation and maintenance of these controlled terminologies. Specific responsibilities include following the robust CDISC standards development process for public review, publication and ensuring they are freely available to all and that the process is transparent for the public.
“CDISC is thrilled to partner with ICH on this protocol initiative towards the establishment and maintenance of controlled terminology for a future digital protocol where study design information is driving better research and review of products,” said Chris Decker, CDISC President and CEO.
ICH and CDISC will support these goals and align activities to support the development, adoption, and implementation of these controlled terminologies.
About CDISC
Clinical Data Interchange Standards Consortium (CDISC) is a global non-profit organization that develops and advances data standards of the highest quality to transform incompatible formats, inconsistent methodologies, and diverse perspectives into a robust framework for generating accessible clinical research data. Driven by the belief that the true measure of data is its impact, CDISC convenes a global community of research experts representing a range of experiences and backgrounds to harness the collective power to drive more meaningful clinical research.
About ICH
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a global organization that brings together regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical development, including, quality, safety, efficacy, terminologies, and electronic standards, with a goal to develop international ICH guidelines and, as relevant, technical specifications.
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