2023 US Interchange Program
Program is subject to change.
All times in US Eastern Time
Click each session to expand to see the presentations, speakers, and summaries.
Session 1: Opening Plenary
Salons 1-4 (Lobby Level)
For the last 20 years, we have navigated from binding folders in boxes, to study data standardization, and electronic submissions. The new landscape is bringing new types of data and technology is continuously evolving around us. In some areas, we have transformed process and capabilities yet in others, we remain stuck in rigid frameworks that have gone unquestioned for decades. The aim of this presentation is to leave you pondering: Is it possible to transform drug development and regulatory assessments?
Session 2: Second Opening Plenary
Salons 1-4 (Lobby Level)
Session 3A: Digitization and AI
Salons 1-3 (Lobby Level)
Session 3B: Business Optimization
Salon 4 (Lobby Level)
Session 3C: ARS Hands-On Workshop
Junior Ballroom (Lower Level)
This workshop will train attendees on the Analysis Results Standards (ARS) model and provide in-depth exploration of key concepts, available examples, and documentation. Through real-world use cases and implementation examples from the CDISC ARS Hackathon, we'll demonstrate the practical application of ARS and discuss the next steps for adopting it in your organization. We will provide practical insights and hands-on exercises to equip you with the knowledge and skills to leverage the CDISC ARS model effectively.
Note: Attendees are encouraged to bring their laptops to actively participate in the training exercises and maximize their learning experience.
Session 4A: Real World Data + Implementation
Salons 1-3 (Lobby Level)
Session 4B: CDISC Foundational, Part I
Salon 4 (Lobby Level)
Non-standard variables (NSVs) are used to represent concepts in SDTM datasets that cannot be represented using standard variables found in the SDTM model. Published NSVs can be found in CDISC IGs, TAUGs, and QRS supplements. However, the non-standard nature of these variables mean that different labels for the same concept and the same label for different concepts may appear across published documents. Therefore some kind of formalism is needed to support the efficient generation and re-use of NSVs. In order to address this challenge, a standards team was formed to identify the extent of the issue, perform an analysis, and deliver a solution. We will describe the NSV Registry, an accessible repository that serves as a reference for searching, requesting, and curating non-standard variables, in order to drive consistency in implementing CDISC Standards.