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?

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.

• Helena Sviglin, FDA-CDER
• Korey Hendricks, BMS
• Scout, National LGBT Cancer Network
• Garo Kiledjian, SGM Alliance

1. Import CDISC data into JMP Clinical software
2. Basic JMP Clinical function
3. Create safety and data quality reports automatically according to clinical trial data
4. Follow FDA NDA safety template to understand the drug safety analysis with figures and tables in NDAs and CRs from JMP Clinical reports such as Demographics, Interventions, Events, Findings, Patient Profiles and Narratives
5. Explore adverse event reporting strategies such as comparing FMQ (FDA Medical Queries) and SMQ (Standardized Medical Queries)

CDISC Open Rules Engine (CORE) experts will provide a hands-on Workshop where you will learn the ins and outs of CORE.

We will show you how to create existing CDISC conformance, regulatory, and sponsor-specific rules, along with data quality checks using the CORE Rules Editor.

Attendees are encouraged to bring their laptops and ensure they are set up with a cdiscID .

• Jesse Anderson, FDA-CDER
• Helena Sviglin, FDA-CDER
• Yuki Ando, PMDA
• Chrissie Cai, FDA-CTP
• Lisa Lin, FDA-CBER