CDISC Interchange2023presentation·Europe·Session 6: Track A- Updates Towards RegulatoryFDA‐CTP and CDISC Project to Develop Tobacco Related Standards to Achieve Efficiencies for All Stakeholders CDISC-DB9A3469 EuropeSee metadata
CDISC Interchange2023presentation·Europe·Session 6: Track A- Updates Towards RegulatoryInternational Council on Harmonization (ICH) Progress Towards and Internationally Harmonized Clinical Electronic Structured Harmonized Protocol (CESharP) CDISC-DF5E4A02 EuropeSee metadata
CDISC Interchange2023presentation·Europe·Session 6: Track B- CORE ImplementationLeveraging CORE for Real Time Validation – No More Endless Iterations CDISC-71B5009B EuropeSee metadata
CDISC Interchange2023presentation·Europe·Session 6: Track B- CORE ImplementationHow the new CDISC Open Rules Engine (CORE) can Improve the Speed and Quality of Dataset Deliverables in Clinical Trials CDISC-79AF7C6C EuropeSee metadata
CDISC Interchange2023presentation·Europe·Session 6: Track B- CORE ImplementationTales from the Journey of a CORE Developer CDISC-684C57F3 EuropeSee metadata
CDISC Interchange2023presentation·Europe·Session 6: Track B- CORE ImplementationHow we Achieved Real Time Validation by Integrating CORE into our Django (Python) Clinical Trial Platform CDISC-E71DBA2A EuropeSee metadata
CDISC Interchange2023presentation·Europe·Session 6: Track B- CORE ImplementationHow to Extend and Run CORE CDISC-FDEB237C EuropeSee metadata
CDISC Interchange2023presentation·Europe·Session 6: Track C- Submission ExperienceThe Journey of a 100 Million Records Submission CDISC-141A2C50 EuropeSee metadata
CDISC Interchange2023presentation·Europe·Session 6: Track C- Submission ExperienceBalancing Quality and Efficiency - a Novo Nordisk Submission Example CDISC-356574D1 EuropeSee metadata
CDISC Interchange2023presentation·Europe·Session 6: Track C- Submission ExperienceEnsuring That a Define-XML is Submission Ready CDISC-D265C699 EuropeSee metadata
CDISC Interchange2023presentation·US·Session 6A: Digital Data FlowDigital Data Flow: Breaking the Document Paradigm with Digital Data Flow from Protocol Design to Electronic Data Capture CDISC-7A6C2C1C North AmericaSee metadata
CDISC Interchange2023presentation·US·Session 6A: Digital Data FlowAutomating Study Set-up through Digitalized Protocol CDISC-40AEEABF North AmericaSee metadata
CDISC Interchange2023presentation·US·Session 6A: Digital Data FlowFrom Medical Writing to Data Management: Key Considerations for Successfully Adopting the Unified Study Definitions Model (USDM) and Enabling Digital Data Flow (DDF) CDISC-F1E3EDC4 North AmericaSee metadata
CDISC Interchange2023presentation·China·Session 6A: Preparation for Data Submission 2It's Easy Peasy Submitting Data to the China NMPA, Really ?? CDISC-0CBD9B97 ChinaSee metadata
CDISC Interchange2023presentation·China·Session 6A: Preparation for Data Submission 2Best Practice of Define-XML v2.1/Define-XML v2.1最佳实践 CDISC-C3029087 ChinaSee metadata
CDISC Interchange2023presentation·China·Session 6A: Preparation for Data Submission 2Experience and Problems Encountered During the Whole FDA BLA Submission and Review Cycle of an Oncology Drug CDISC-D508198B ChinaSee metadata
CDISC Interchange2023presentation·China·Session 6B: Academic and Information TechnologyCurrent Status, Limitations and Trends of CDISC Academic Research CDISC学术研究现况、局限性及趋势 CDISC-35366AEC ChinaSee metadata
CDISC Interchange2023presentation·China·Session 6B: Academic and Information TechnologyHow Invisible Encoding put Impact on Data Storage and Display 看不见的编码是如何影响数据的储存以及显示 CDISC-F784C83D ChinaSee metadata
CDISC Interchange2023presentation·US·Session 6B: CDISC Foundational, Part IICurrent and Forthcoming ADaM Publications CDISC-1B688F5D North AmericaSee metadata
CDISC Interchange2023presentation·US·Session 6B: CDISC Foundational, Part IIADaM Discussion Topics: PARQUAL, ADPL, and NADIR CDISC-23F92E49 North AmericaSee metadata