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SDTM Implementation Guide Version 3.1.2

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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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slide1

SDTM

Implementation Guide

Version 3.1.2

Kurt Hellstern

Hands-on GmbH

slide2

Short Summary

  • Nothing
    • Still domains, special purpose, events, etc.
    • Still everything focussed on submissions of SAS Transport files
  • Everything
    • A lot of details
slide3

Highlights

  • Some new domains
  • Splitting domains
  • Some new variables
  • Some variables deleted
  • Long list of detail changes
  • No lists of controlled terminology
slide4

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
slide5

Splitting Domains

FA  FAAE

FAEX

Rule: Must technically be equal for concatination

slide6

New / Deleted Variables

  • Example:
  • New: AEPRESP: pre specified Aes
  • Deleted: AEOCCUR: made no sence
slide7

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
slide8

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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