CDISC Interchange2024presentation·Japan·Session 5: Regulatory Updates, Part IIDataset-JSON Pilot Report and Next Steps CDISC-27008D07 Asia-PacificSee metadata
CDISC Interchange2024presentation·Japan·Session 5: Regulatory Updates, Part IIUS FDA’s Study Data Policy Framework and Recent Activities CDISC-ED927110 Asia-PacificSee metadata
CDISC Interchange2024presentation·Europe·Session 5A: CORE ImplementationAdopt and Adapt CDISC CORE: A Sponsor's Reflections CDISC-7D79B961 EuropeSee metadata
CDISC Interchange2024presentation·Europe·Session 5A: CORE ImplementationOur Road to Adopting CORE: An Implementation Journey in SDTM Dataset Validation CDISC-DC23DCFA EuropeSee metadata
CDISC Interchange2024presentation·Europe·Session 5A: CORE ImplementationImplementing CDISC CORE in a Cloud Native, Regulated Environment Supporting Rare Disease Submissions CDISC-F668AE32 EuropeSee metadata
CDISC Interchange2024presentation·US·Session 5A: Concepts in PracticeBiomedical Concept/Analysis Concept Use Case - Protocol, Collection, Analysis, Mapping CDISC-96D6ADC1 North AmericaSee metadata
CDISC Interchange2024presentation·US·Session 5A: Concepts in PracticeAnalysis Concepts at Roche CDISC-052176B6 North AmericaSee metadata
CDISC Interchange2024presentation·US·Session 5A: Concepts in PracticeConcepts in Practice Presentation CDISC-841353AB North AmericaSee metadata
CDISC Interchange2024presentation·US·Session 5A: Concepts in PracticeActivity Concepts in OpenStudyBuilder CDISC-27622246 North AmericaSee metadata
CDISC Interchange2024presentation·Europe·Session 5B: COSALifting the Language Barrier: Choosing not to Choose CDISC-5EEB2991 EuropeSee metadata
CDISC Interchange2024presentation·Europe·Session 5B: COSAHow to Build a Global, Reusable, Shareable Metadata Flow with a Customer-Centric Focus CDISC-643EE7FD EuropeSee metadata
CDISC Interchange2024presentation·Europe·Session 5B: COSAOpen-Source Practicalities and the Legal Side CDISC-CB185256 EuropeSee metadata
CDISC Interchange2024presentation·US·Session 5B: RegulatoryFood Allergy Research with CDISC Standards CDISC-3B76FBA4 North AmericaSee metadata
CDISC Interchange2024presentation·US·Session 5B: RegulatoryICH Initiatives: M4Q(r2)/Q12/M11 and Global Harmonization; Impacts to Regulatory Submissions CDISC-8B6326C8 North AmericaSee metadata
CDISC Interchange2024presentation·US·Session 5B: RegulatoryConventional Wisdom for Conventional Units CDISC-7918D6F9 North AmericaSee metadata
CDISC Interchange2024presentation·US·Session 5B: RegulatoryNavigating Regulatory Compliance: Complexities around the EU Clinical Trials Regulation CDISC-A0DAC39A North AmericaSee metadata
CDISC Interchange2024presentation·US·Session 5C: Special Topics / Implementing CDISCStatus of CDISC Implementation and Outreach Activities in Japanese Academia CDISC-2C77093C North AmericaSee metadata
CDISC Interchange2024presentation·US·Session 5C: Special Topics / Implementing CDISCAdvancing Clinical Trial Diversity: Beyond the Traditional Race Categories CDISC-3D74F040 North AmericaSee metadata
CDISC Interchange2024presentation·US·Session 5C: Special Topics / Implementing CDISCADaM Adventures in Oncology CDISC-B9B3CB89 North AmericaSee metadata
CDISC Interchange2024presentation·US·Session 5D: End of Study Challenges (TMF Track)TMF Migrations and Transfers for Mergers and Acquisitions CDISC-AF9090B9 North AmericaSee metadata