In 2022, the ICH M11 Working Group released draft guidelines for a Clinical Electronic Structured Harmonized Protocol (CeSHarp). Key principles include "defining content for electronic exchange" and "design for content reuse." The guidelines aim to align various ongoing efforts effectively. The CDISC and TransCelerate collaboration on a Unified Study Definitions Model (USDM) will have its third release in April, providing a data model with controlled terminology and API specifications. In June 2023, CDISC and HL7 FHIR Accelerator Vulcan announced plans to use the USDM to advance the ICH M11 project. The presentation will discuss the opportunity to bring together collective expertise and established building blocks to innovate and digitalize clinical research, highlighting potential impacts on stakeholders.)

The Data Sharing Policy of the US NIH has been revised in conjunction with the progress of the GREI project, and Vivli is one of the seven repositories partnered with the NIH, providing a data sharing mechanism compliant with NIH's Policy. Vivli is also involved in reviewing the NIH's Common Data Elements in collaboration with CDISC. Additionally, we have commenced collaborative research with Duke University, the originator of the term ARO. We will have a presentation on the progress and changes in the surrounding environment since last year's announcement.

Since 2015, NHO Nagoya Medical Center has implemented CDISC standards in investigator-initiated study. As of 2024, these standards are employed in 9 investigator-initiated studies, 25 intervention studies, and 12 observational studies. The adoption of CDISC standards has unified terminology across trials through Controlled Terminology and standardized database structures and variable names using SDTM. This initiative has also standardized CRFs and operational processes, facilitated smoother inter-departmental communication, and promoted the secondary use of data. In this presentation, we will showcase case studies from NHO Nagoya Medical Center, highlighting achievements made possible by leveraging CDISC standards within the constraints of an Academic Research Organization (ARO).

We have established an "SDTM subteam for CDISC beginners" within the CDISC Japan User Group(CJUG) SDTM team, starting in December 2022. The primary purpose is to contribute to human resource development and promote CDISC implementation in AROs through knowledge and skills on CDISC by practicing SDTM data set creation through a mock protocol. We have completed EDC construction and the creation of the Trial Design Model. We are considering creating materials, including flowcharts, specific tasks, and templates at each stage for beginners unfamiliar with the workflow that will lead to the creation of SDTM datasets. Our team is gaining experience implementing CDISC standards in Japanese academia and creating materials that make it easier for team members to transfer their knowledge and skills to their respective organizations. In this workshop, we will introduce the roadmap of our team activities along with the achievements to date.

This presentation will summarise the major European initiatives, mostly public private partnerships involving academia, the pharmaceutical industry, and other stakeholders, to develop the use cases, information architectures and grow the market of commercial products that use hospital electronic health record data to improve the efficiency of clinical trial design and conduct. The talk will cover projects such as EHR4CR, EHR2EDC, EU Pearl, c4c and EHDEN, which have each focused on different points in the clinical trial life cycle or provided a data platform for large scale observational studies. The talk will conclude with the exciting outlook in Europe through the forthcoming European Health Data Space, and its prospects for scaling up the availability of large populations of patient summaries that could be queried for clinical trial purposes. The xShare project is now developing specifications to help enhance that opportunity.