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PLEASE NOTE: All listed webinars are in US Eastern time, unless otherwise indicated.
Introducing the TMF Investigator Site File (ISF) v1 (Japan/Asia Pacific)
The CDISC TMF team is pleased to announce the release of the Investigator Site File (ISF) v1!
Join us for a webinar that will introduce the model, provide guidance on how to use it, and address any questions.
Language
English
Overview and discussion of major scope changes in SDTMIG v4.0 and SDTM v3.0
Language
English
360i Phase 2: From Vision to Implementation - Lessons Learned and the Road Ahead
Join the CDISC leadership team to learn about the next phase of the 360i Initiative.
CDISC 360i is transforming clinical research by digitizing study design through analysis, making metadata interoperable across the entire study lifecycle. With reusable standards and end-to-end automation, 360i reduces manual tasks, increases data quality, enables AI, ensures traceability and consistency, and empowers the industry to deliver clinical trial results faster, more efficiently, and at a lower cost — accelerating the delivery of new therapies to patients.
In this webinar, CDISC will share details on the next steps in the 360i Initiative, including:
- Digital Transformation needs, stakeholders, and opportunities
- Art of the Possible: vision of how connected standards and digital protocols can drive automated study build and workflows
- Highlights of 360i Phase 1 achievements and findings
- Overview of what’s new in 360i Phase 2, including Analysis Concepts, Digital Data Transfer Agreements, and enhanced automation capabilities that will build on Phase 1 findings to generate analysis artifacts.
- Call For Action: opportunities to contribute and collaborate
Join the conversation to see what’s coming next in 360i and how you can help shape the future of digitally-enabled, standards-based clinical research.
Speakers
- Chris Decker, CEO and President, CDISC
- Peter Van Reusel, Chief Standards Officer, CDISC
- Julie Smiley, Chief Information Officer, CDISC
Language
English
Overview and discussion of major scope changes in SENDIG v4.0
Language
English
Members Only: CRF Specializations and their Relation to CDISC Biomedical Concepts
Biomedical Concepts (BCs) are a foundational component of CDISC 360i, enabling automation, interoperability, and seamless data flow from study design through analysis by making clinical concepts computable rather than narrative-only. This webinar offers a brief re-orientation to CDISC Biomedical Concepts and SDTM Dataset Specializations including a summary of the BC accomplishments (2022 - present). The session will also include an introduction to 'CRF Specializations' which provide machine-readable metadata describing CRF assessments linked to BCs, another key step towards achieving the CDISC 360i vision.
Agenda:
- Re-Orientation to CDISC BCs and SDTM Dataset Specializations
- CDISC BC Curation Accomplishments (2022-present)
- CDISC CRF Specializations (Introduction, Assumptions, Data Model)
- CDISC 360i Update
Language
English
How AI and Standards Work Together: Insights from the CDISC AI Innovation Biomedical Concepts Acceleration Challenge
Biomedical Concepts (BCs) play a critical role in connecting data seamlessly from protocol through analysis and regulatory submission (a foundational goal of 360i). This webinar will discuss how BCs enable semantic interoperability by highlighting use cases from the CDISC AI Innovation Challenge, focused on Biomedical Concepts Acceleration. Participants demonstrated how AI and machine learning can streamline the development and curation of BCs by leveraging existing standards and data. Join us for insights, lessons learned, and live demonstrations showing how the acceleration of identification and creation of BCs provides a semantic layer across CDISC foundational standards.
Agenda
- Overview of the AI Biomedical Concepts Acceleration Challenge and Key Learnings (10 minutes)
- AI BC Acceleration Demonstration #1: Saama (10 minutes)
- AI BC Acceleration Demonstration #2: Lindus Health (10 minutes)
- Q&A Session (10 minutes)
Speakers
- Julie Smiley, Chief Information Officer, CDISC
Language
English
