2026 Europe Interchange Call for Abstracts - CDISC Abstracts

Instructions

 

Please use the form below to submit your abstract for consideration. PLEASE MAKE SURE TO PRESS THE SUBMIT BUTTON AT THE BOTTOM OF THE FORM. You should see a confirmation page after successful submission.

 

2026 Europe Interchange Call for Abstracts - CDISC Abstracts

 

Theme: The Future is Connected: Standards and AI Powering Digital Transformation

Abstracts Due: Friday, 9 January 2026

 

We welcome abstracts for the 2026 Europe Interchange on any of the CDISC topics listed below. Related use cases are encouraged. We want to hear your success stories even if they do not fit into the topic areas mentioned.

 

Accelerating Digital Transformation through End-to-End Automation and Validation with CDISC360i and Open-Source Tools

  • Experiences in adopting the Digital Data Flow (DDF): exploring digital protocol creation, ICH M11, the USDM standard and automated study builds.
  • Integrating the DDF with upstream and downstream processes: examining challenges, benefits, and potential extensions.
  • Leveraging open-source tools to enable standards-based automation across the clinical data lifecycle.
  • Implementing CDISC Open Rules – Hands-on experience with custom rule development, AI-assisted rule authoring and automated dataset validation through CORE.
  • CDISC360i End-to-End Data Flow and Concept Modelling – Demonstrating metadata-driven workflows and automated transformations powered by biomedical and analysis concepts.

 

CDISC Foundational Standards

  • Early adoption of SDTM 3.0 and SDTMIG 4.0. Use cases of new domains like EA or DC. Implications of change to NS--.
  • Early adoption of SDTM 3.0 and SENDIG 4.0. Use cases of new domains like PI or SX. Implications of change to NS--.
  • Community updates of what will be new in CDASH 2.0 and CDASHIG 3.0.
  • Examples on ADaM ADA and PP datasets. Use of the new ADaM + IG 3.0.

 

Innovation in Clinical Trials

  • Exploiting Decentralized Trials, including Digital Endpoints, Master Protocols, Patient and Rare Disease Registries, Secondary use of Legacy Clinical Trials.
  • New Ways of Working That Simplify Processes and Improve Quality, Streamlining Clinical Trial Processes, Leveraging AI for Data Insights, Improving Patient Selection and Recruitment.
  • Frameworks for AI in Clinical Trials, CDISC Standards and AI Integration -learnings from hackathons and ideas to shape future innovation.

 

Real World Data Use Cases

  • Real World Data (RWD): Experiences of RWD/RWE in Regulatory Decision-Making for Drugs and Biologics. Use of CDISC and other industry standards (OMOP Data Model, HL7 FHIR, etc.), including conversions between standards, regulatory guidance, progress, and barriers.
  • Electronic Health Records (EHR), Integration of EHR data in clinical research, standardization and interoperability, regulatory considerations and ruture directions.
  • Digital Health Technologies (DHT), the role of DHT in enhancing clinical trials, regulatory framework and challenges, future perspectives on DHT in clinical research.
  • Use cases describing the use of CDISC standards in academic research and challenges for academia.
  • Use of CDISC standards in healthcare data systems, including eSource/direct to patient apps.
  • Use of CDISC standards for data harmonization to facilitate data sharing and reuse.

 

Global Regulatory Submissions

  • Submission to FDA/PMDA/NMPA learnings, do's and don'ts, provide proper documentation.
  • Submitting around the Globe, submission experience with other Health Authorities e.g. EMA, Canada, etc.
  • Experience and adherence to FDA division guidance (e.g., CBER Vaccine, CDER NASH, etc.) vs CDISC standards (e.g., differences, deviations from the standards, special requests).
  • Experience integrating data from multiple studies in support of Integrated Summary of Safety (ISS) and Integrated Summary of Effectiveness (ISE).
  • Imagine Data Submission in 2041: how technology, standards and industry initiative can accelerate data submission (e.g. open source, new data exchange formats).
Contact Information
Abstract Submission
General Topic

Upload paper (not required).

After uploading, you MUST also hit the "Submit" button at the bottom of the form to submit your abstract. If your abstract should be accepted, please note that your submitted summary will be used in our online program.

One file only.
30 MB limit.
Allowed types: pdf, doc, docx.
Submission Guidelines:
  1. All author(s) approve submitting this work for presentation.
  2. The author(s) agree(s) to materially confine their presentations to information in the abstract if accepted for presentation.
  3. The author(s) acknowledges that, should their abstract be selected, only two speakers can present during any one presentation, and only one speaker can receive the Speaker Rate. Additional speakers will need to register at their membership rate.
  4. I acknowledge that if I am unable to present and fail to notify the planners and my session chair in a timely fashion, this may affect my ability to present at future CDISC Interchanges.
  5. Submission of the contact details provided are those of the presenter of the abstract. The primary author will be notified about the status of the abstract and is responsible for informing the other authors about the status of the abstract.
  6. That abstract author(s) agree(s) to avoid commercial content and refrain from overt selling of a product or service during their presentations.
  7. That most presentation time slots are expected to be 30 minutes total. This includes a 2-minute introduction, 20 minutes for presentation, 5 minutes for Q&A, and 3 minutes for transition between tracks.
  8. Submission of the abstract constitutes consent of all authors that CDISC will make presentation(s) and paper(s) available online, whether in video or PDF format, to the conference attendees, and after six (6) months, to the CDISC member community.
  9. If, after confirming their participation in the Interchange, the author(s) are unable to present due to extenuating circumstances, the author(s) should first attempt to determine and notify their session chair and planners of an appropriate replacement.

WE LOOK FORWARD TO RECEIVING YOUR CONTRIBUTION!

Questions?

If you have any questions on the suitability of an abstract or about the submission process, please contact CDISC at events@cdisc.org.

I confirm that I am submitting this abstract as CDISC content for the EU Interchange.