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SDTM Implementation Guide Version 3.1.2 PowerPoint PPT Presentation


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SDTM Implementation Guide Version 3.1.2. Kurt Hellstern. Hands-on GmbH. Short Summary. Nothing Still domains, special purpose, events, etc. Still everything focussed on submissions of SAS Transport files Everything A lot of details. Highlights. Some new domains

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SDTM Implementation Guide Version 3.1.2

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Sdtm implementation guide version 3 1 2

SDTM

Implementation Guide

Version 3.1.2

Kurt Hellstern

Hands-on GmbH


Sdtm implementation guide version 3 1 2

Short Summary

  • Nothing

    • Still domains, special purpose, events, etc.

    • Still everything focussed on submissions of SAS Transport files

  • Everything

    • A lot of details


Sdtm implementation guide version 3 1 2

Highlights

  • Some new domains

  • Splitting domains

  • Some new variables

  • Some variables deleted

  • Long list of detail changes

  • No lists of controlled terminology


Sdtm implementation guide version 3 1 2

New Domains

  • ... as the work progresses

  • Reserved codes for sponsor defined domains: X, Y and Z

  • Special case FA: Findings AboutExample: AE Severity over time


Sdtm implementation guide version 3 1 2

Splitting Domains

FA  FAAE

FAEX

Rule: Must technically be equal for concatination


Sdtm implementation guide version 3 1 2

New / Deleted Variables

  • Example:

  • New:AEPRESP: pre specified Aes

  • Deleted:AEOCCUR: made no sence


Sdtm implementation guide version 3 1 2

Small Changes Everywhere

  • 3 pages of small changes in change log

  • Need to care about:

  • SITEID no longer unique within submission

  • New concept for Race

  • New concept for missing data

  • New properties: e.g RFSTDTC and RFENDTC now Record Qualifiers, but no longer Timing

  • Clarification reagrding ISO 8601 date format


Sdtm implementation guide version 3 1 2

Commitment

FDA does not yet accept datasets

based upon this version

CDISC expects commitment “soon“

Why don´t you task the risk?


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