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?