Austin, Texas, USA and Geneva, Switzerland - 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.
