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

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Presentation on theme: "1 SDTM Implementation Guide Version 3.1.2 Kurt Hellstern Hands-on GmbH."— Presentation transcript:

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

2 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 3 Highlights Some new domains Splitting domains Some new variables Some variables deleted Long list of detail changes No lists of controlled terminology

4 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 5 Splitting Domains FA FAAE FAEX Rule: Must technically be equal for concatination

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

7 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 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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