2025 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.

 

2025 Europe Interchange Call for Abstracts - CDISC Abstracts

Abstracts Due: Friday, 17 January 2025

We welcome abstracts for the 2025 Europe Interchange on any of the CDISC topics listed below.

 

New Data Sources

  • 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 Future Directions
  • Digital Health Technologies (DHT), The Role of DHT in Enhancing Clinical Trials, Regulatory Framework and Challenges, Future Perspectives on DHT in Clinical Research

Digital Design

  • 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
  • The influence of the DDF on drug development

CDISC Foundational Standards

  • CDASH/IG 1.3/3.0
  • SDTM/IG 2.2/4.0
  • ADaM/IG 3.0/1.4
  • SEND/IG 2.2/4.0
  • Define-XML v2.1
  • LAB Model 2.0

Innovation in Clinical Trials and CDISC Standards

  • Modernization of Clinical Trials and Impact on CDISC Standards: Decentralized Trials, including Digital Endpoints, Master Protocols, Patient and Rare Disease Registries
  • New Ways of Working That Simplify Processes and Improve Quality, Streamlining Clinical Trial Processes, Enhancing Data Quality Through Automation
  • Applications of AI to Extract Value from Clinical Trials and Real World Data, Leveraging AI for Data Insights, Improving Patient Selection and Recruitment
  • Regulatory and CDISC Positioning on Usage of AI, Guidance and Frameworks for AI in Clinical Trials, CDISC Standards and AI Integration
  • Accessing the Standard Library for SDTM/CDASH in an Easy and Innovative Way, Innovative Approaches to Standard Library Access, Training and Support for Effective Use

Open Source Usage, Including CORE, OAK, COSMoS

  • Experience in adopting the CDISC Open Rules: Rules Authoring Tool, creation of data conformance rules or implementation of the Rules Engine
  • Exploring various tools for validation of data: SEND, SDTM, ADaM, Define-XML etc.
  • Experience utilizing Open Source tools

CDISC in Academic 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
  • Non-standard implementation of CDISC standards
  • Use of CDISC standards for data harmonization to facilitate data sharing and data reuse including:
    • Individual Participant-Level Data (IPD) Meta-Analysis
    • Data Integration
    • Opportunities across the life sciences data sharing (FAIRified) ecosystem post anonymization of critical GDPR data

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 Authoritiese.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 fasten data submission (e.g. open source, new data exchange formats)

CDISC 360i End-to-End Adoption

  • Biomedical concepts, analysis concepts and extensions
  • Automation of data flow - demonstration of end-to-end flow and automated transformations

Analysis Results Standards - ARS

  • From theory to practice - implementation challenges
  • Automation
  • Supportive software and formats
  • Experiences from volunteers and contributors

 

OTHER CDISC STANDARDS TOPICS

You are welcome to submit an abstract on any CDISC model experience, its implementation and associated planning. Related use cases are encouraged. We want to hear your success stories even if they do not fit into the topic areas mentioned.  CDISC is an open and multidisciplinary standard which interfaces with many areas and we are eager to hear about your experiences working with standards.

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.

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. 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.
  4. 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.
  5. That abstract author(s) agree(s) to avoid commercial content and refrain from overt selling of a product or service during their presentations.
  6. 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.
  7. 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 Europe Interchange.