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SDTMImplementation 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?