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SDTM Implementation Guide Version 3.1.2

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Presentation on theme: "SDTM Implementation Guide Version 3.1.2"— Presentation transcript:

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 About Example: 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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