Optimizing the Use of Data Standards:SDTM/ADaM FAQ

2017 EU-CSS

24 May 2017

• 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

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

Emerging Trends & TechnologyReimagining Clinical Data

2017 EU-CSS

24 May 2017

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…

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