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

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SDTM ADaM Implementation FAQ Workshop

Peter Van Reusel and Amy Palmer, CDISC

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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

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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

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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

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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

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CDISC – What’s New

• Current and upcoming development work by

foundational teams

• Preview of CDISC 2.0 Pilot
• Other Initiatives - increasing clarity

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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

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