SDTM Implementation Guide Version 3.1.2

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Presentation transcript:

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

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

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

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

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

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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