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 - - 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


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#PhUSE

SDTM ADaM Implementation FAQ Workshop

Peter Van Reusel and Amy Palmer, CDISC

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#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

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

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#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
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#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
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#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

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#PhUSE

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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#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
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#PhUSE