CDISC

Join us for CDISC’s first-ever Biomedical Concepts Hands-On Implementation training at the upcoming Europe Interchange! This half-day, in-person session will be held on 12 May from 2:00 PM – 6:00 PM and is ideal for those seeking foundational knowledge and practical skills in modeling and curating Biomedical Concepts (BCs) and Dataset Specializations. Led by CDISC experts Bess LeRoy and Dagmar Kottig-Roth, the training features guided activities, real-world examples, and hands-on exercises tied to the broader 360i ecosystem. Participants will leave equipped to review, provide feedback on, and create aligned BCs and Dataset Specializations. They will also earn a Certificate of Achievement and a digital badge upon successful completion of the training. Register: https://lnkd.in/eVRcadZ5

The CDISC+TMF Europe Interchange held in Geneva on 14-15 May will showcase keynote presentations on unique and powerfully important topics by experts in diverse fields. This includes distinguished speakers from the Vasee Moorthy MD PhD from the World Health Organization (WHO), Torsten Stemmler from BfArM (Federal Institute for Drugs and Medical Devices in Germany), Dimitrios Athanasiou MBA from the World Duchenne Organization. The full program is available now!  https://lnkd.in/erHrwZBx #cdisc2025europe #cleardataclearimpact

The FDA has released an updated Study Data Technical Conformance Guide, outlining key specifications and recommendations for standardized study data submissions. This update supports regulatory compliance for INDs, NDAs, ANDAs, and BLAs, reinforcing the importance of CDISC standards in ensuring high-quality, consistent data for regulatory review. #cleardataclearimpact

New Library Updates are now available! Biomedical Concepts Package 11 is now available! New CDISC Biomedical Concepts(BCs) and SDTM Dataset Specializations have been released. In addition, improvements and enhancements have been made to existing BCs and SDTM to improve consistency and accuracy: https://lnkd.in/ehpsQRu3 Controlled Terminology (CT) Package 59, developed in partnership with the NCI-EVS, includes updates to ADaM, CDASH, Define-XML, Protocol Entities, SDTM, and SEND Controlled Terminology: https://lnkd.in/eWWCa_M The Define-XML schema for Define-XML v2.1 has been updated to version 2.1.9 to reflect the 2025 Q1 CDISC Controlled Terminology Package 59. Details about what changed are provided in the ReadMe file. Changes in the updated enumeration schema include additional terms in StandardName (C170452) enumeration: • ADaM-OCCDSIG (C214535) • ADaMIG-MD (C214532) • ADaMIG-NCA (C214533) • ADaMIG-popPK (C214534) Use this link https://lnkd.in/dCwBCdBR to download the updated schemas. Older versions can be found at the archive: https://lnkd.in/eMAYKhcA #cleardataclearimpact

CDISC proudly celebrates our collaboration with partners in advancing standardized and harmonized data collection for pediatric clinical trials! In partnership with conect4children, Newcastle University, and John Walton Muscular Dystrophy Research Centre @ Newcastle University, we are driving innovation in pediatric research through the power of standardized data. Key milestones include: • Publication of the Pediatrics User Guide v1.0 – A comprehensive resource guiding the use of CDISC standards to structure pediatric clinical trial data, supporting data sharing and big data analysis. (https://lnkd.in/dmjweAfT) • CDISC Pediatrics User Network (CPUN) – a volunteer-led group, fosters collaboration and provides a feedback loop for implementing CDISC standards in pediatric research. (https://lnkd.in/e7HxREMe) • Upcoming Free Training – CDISC Pediatrics On-Demand Training launches end of April 2025! This self-paced course will provide practical insights into implementing the Pediatrics User Guide v1.0 to optimize pediatric clinical trial data. Stay tuned for more details! • Scholarly Contributions – Advancing pediatric research data standards through recent publications: • CDISC Standards for Pediatric Data: Current Progress and Future Directions – Frontiers in Medicine https://lnkd.in/eREqKdS6 • Applying CDISC Standards to Pediatric Research: Lessons from the c4c Consortium – MDPI Data Journal https://lnkd.in/eaV3tPYF A heartfelt thank you to our partners and volunteers for their dedication to advancing pediatric clinical research through the power of data! #cleardataclearimpact #pediatrics #pediatricclinicaltrials

Imagine a world without CDISC, where confusion slows progress and critical data is hard to find... For over 20 years, Sandra Minjoe has been at the forefront of implementing and shaping CDISC standards. As a longtime volunteer and industry expert, she has witnessed firsthand how CDISC has transformed clinical research - eliminating inefficiencies, improving communication, and ensuring data is easily accessible. As we celebrate CDISC’s 25th anniversary, Sandra reflects on the critical role CDISC plays in driving progress. Watch her share why she believes the industry could not function without it. We invite you to be part of our next chapter. Support our mission, become a member, and help shape the future of clinical research. Donate today: https://lnkd.in/eHxv96DB Join the CDISC Community: https://lnkd.in/gNBmAcxZ #CDISC2025

We are thrilled to welcome Dr. Torsten Stemmler, Head of GCP Inspections at BfArM, as our TMF keynote speaker in Geneva on 14–15 May for the CDISC+TMF Europe Interchange. With deep expertise in GCP inspections, regulatory guidelines, and AI in clinical research, Dr. Stemmler will provide critical insights into ICH E6 R3 and the TMF in his keynote address. • Keynote Presentation – ICH E6 R3 and the TMF | Wednesday, 14 May • Panel Discussion – Culture Change Driving Inspection Success | Wednesday, 14 May • Panel Discussion – Risk-Based Approaches in Line with ICH E6 R3 | Wednesday, 14 May • Expert Commentary – ISF Model Discussion with Jamie Toth | Thursday, 15 May Don’t miss this opportunity to engage with leading experts and shape the future of clinical trial oversight. Register now to secure your spot! https://lnkd.in/eVRcadZ5 #cdisc2025europe #cleardataclearimpact #tmf

The latest OpenStudyBuilder release introduces key enhancements, including improvements to concepts, events, and study definitions. CDISC is proud to support advancements in structured study definitions, ensuring greater efficiency and interoperability in clinical research. Learn more about the latest updates from Katja Glass and the OpenStudyBuilder team: https://lnkd.in/em7NQu-c

Join authorized CDISC-instructor, Bhavin Busa, for the ARS Hands-on Implementation Training to be held in Boston on 11 April! Seats are limited – reserve your space now: https://lnkd.in/g2Kf2i3u Analysis results play a crucial role in the drug development process, providing essential information for regulatory submission and decision-making. However, the current state of analysis results reporting is suboptimal, with limited standardization, lack of automation, and poor traceability. Currently, analysis results (tables, figures, and listings) are often presented in static, PDF-based reports that are difficult to navigate and vary between sponsors. Moreover, these reports are expensive to generate and offer limited reusability. To address these issues, the CDISC Analysis Results Standard (ARS) team has developed a logical model to support consistency, traceability, and reuse of results data. This hands-on implementation training will provide an in-depth overview of the ARS model and practical examples illustrating the implementation of the model using common safety displays. Training to be hosted by Clymb Clinical. #cleardataclearimpact

The International Council for Harmonisation (ICH) has opened a second public consultation on the M11 Clinical electronic Structured Harmonised Protocol (CeSHarP) Technical Specification (ICH Official web site: https://lnkd.in/gY4pKERw). This consultation allows stakeholders to review and comment on the updated specification, which aligns with the refined protocol template based on prior public feedback and ongoing expert input. CDISC is excited about our work with ICH to support the maintenance and governance of ICH M11 controlled terminology and look forward to continued collaboration as we move towards a digital protocol world.