Transcript SDTM Implementation Guide Version 3.1.2

SDTM
Implementation Guide
Version 3.1.2
Kurt Hellstern
Hands-on GmbH
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Short Summary
• Nothing
• Still domains, special purpose, events, etc.
• Still everything focussed on submissions
of SAS Transport files
• Everything
• A lot of details
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Highlights
• Some new domains
• Splitting domains
• Some new variables
• Some variables deleted
• Long list of detail changes
• No lists of controlled terminology
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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
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Splitting Domains
FA 
FAAE
FAEX
Rule: Must technically be equal for concatination
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New / Deleted Variables
Example:
New:
AEPRESP: pre specified Aes
Deleted:
AEOCCUR: made no sence
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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
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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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