1 / 8

SDTM Implementation Guide Version 3.1.2

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

kelsie-ball
Download Presentation

SDTM Implementation Guide Version 3.1.2

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  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 don´t you task the risk?

More Related