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Optimizing the Use of Data Standards:SDTM/ADaM FAQ
2017 EU-CSS
24 May 2017
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• Industry lacks a common knowledge base for SDTM and ADaM implementation issues in clinical research
• Provides a forum for industry, CDISC, and other experts to collaboratively address SDTM and ADaMimplementation challenges• Co-sponored by CDISC
• (Very) active sub-teams• IG Nuances• Validation / Conformance Rules• Data Submissions• Trial Design Domains
SDTM/ADaM FAQ: Project Overview
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Facilitators: • Chris Price, Roche • Scott Bahlavooni, d-wiseAgenda:• Project overview and update• CDISC 2017-2018 Roadmap• Roundtable discussion: I need help….• FAQ breakout • Summary and next steps
SDTM/ADaM FAQ: EU-CSS Agenda
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Emerging Trends & TechnologyReimagining Clinical Data
2017 EU-CSS
24 May 2017
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We think like this…We live like this…What if we did this?
02
02
…why do we do this?If we work like this…
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Facilitators: • Scott Bahlavooni, d-wiseAgenda:• Overview and objectives• Explore a problem statement • Demonstration• Hands-on breakout exercise
• Laptops are helpful, but not required• Exercise debrief• Summary and next steps
Reimagining Data: EU-CSS Agenda
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