SDTM ADaM Implementation FAQ Workshop Peter Van Reusel and Amy - PowerPoint PPT Presentation

SDTM ADaM Implementation FAQ Workshop Peter Van Reusel and Amy Palmer, CDISC #PhUSE

SDTM ADaM Implementation FAQ Project Background • The Standards Implementation Nuances sessions at the Mar 2016 North America CSS and Jun 2016 EU CSS surfaced various common challenges amongst SDTM and ADaM implementers and consumers • Industry in need of a forum and subsequent knowledgebase (FAQ) to address these challenges • Active collaboration across PhUSE, CDISC, and FDA #PhUSE

https://www.phuse.eu/wiki-feedback #PhUSE

Overview of Workshop • Update of what is new at CDISC • This hands on workshop is an extension of the PhUSE CSS “SDTM ADaM Implementation FAQ” project (under the Working Group “Optimizing Use of Data Standards”) – Project Co-Leads • Bhavin Busa • Kiran Kumar Kundarapu • Amy Palmer • Wendy Dobson #PhUSE

Workshop Agenda • CDISC – What’s New 20’ • Breakout sessions to discuss 4-6 SDTM ADaM Implementation topics 30’ • Overview of deliverables (past and future) for the SDTM ADaM FAQ Team 20’ – Highlights of Best Practices – https://www.phusewiki.org/wiki/index.php?title=SDTM _FAQ_Team_Responses • Discussion from breakout session 20’ • Next Steps #PhUSE

Workshop Organization • The workshop attendees are expected to bring their laptops to the workshop • Discussion leads are assigned per discussion topics to take notes and provide a read-out of the discussion • The actual discussion topics will be provided before workshop (1 Week) to allow attendees to read up on the topic #PhUSE

CDISC – What’s New • Current and upcoming development work by foundational teams • Preview of CDISC 2.0 Pilot • Other Initiatives - increasing clarity #PhUSE

SDTM ADaM Implementation Topics – White paper on ‘Best Practices for the Preparation of the ISS/ISE Datasets’ – White paper on ‘Best Practices for the Submission of Results from Event Adjudication Process’ – Actively addressing frequently asked questions on following sub-topics: • SDTM ADaM IG Nuances • Validation / Conformance Rules • Data Submissions (SDTM & ADaM) • Legacy SDTM Mapping • Trial Design Domains #PhUSE

#PhUSE