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SDTM Implementation Guide Version 3.1.2

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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  1. SDTM Implementation Guide Version 3.1.2 Kurt Hellstern Hands-on GmbH

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

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

  4. 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

  5. Splitting Domains FA  FAAE FAEX Rule: Must technically be equal for concatination

  6. New / Deleted Variables • Example: • New: AEPRESP: pre specified Aes • Deleted: AEOCCUR: made no sence

  7. 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

  8. 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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