ICH and CDISC Collaborate to Support the Maintenance and Governance Process for ICH M11 Controlled Terminology
2024年7月19日 - 12:21AM
ビジネスワイヤ(英語)
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240718403503/en/
CDISC Contact: Melissa Kirwin mkirwin@cdisc.org