SDTM Implementation Guide Version 3.1.2

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
dont you task the risk?