Implications for SDTM
CDER Common Data Standards Issues Document ... - CDISC Portal
CDER Common Data Standards Issues Document ... - CDISC Portal
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CDER’s Rules of Thumb<br />
• Submit <strong>SDTM</strong><br />
• Document it with define.xml and define.pdf<br />
• If you submit <strong>SDTM</strong>, also submit ADSL<br />
• Derive ADaM datasets from the submitted <strong>SDTM</strong><br />
• Ensure traceability from CRF to <strong>SDTM</strong> to ADaM<br />
• Use CDISC controlled terminology<br />
• Use MedDRA as it comes from the dictionary, use a<br />
single version <strong>for</strong> the ISS, don’t include numeric<br />
codes<br />
• Don’t use Suppquals as a wastebasket<br />
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