Six New SDTM Domains for Medical Devices
Carey Smoak - CDISC Portal
Carey Smoak - CDISC Portal
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CDISC<br />
• Examples of differences (CRF analysis):<br />
• AE -> <strong>for</strong> lab operators (not subjects)<br />
• Non-subject data domains under development<br />
• DV -> Protocol deviations <strong>for</strong> devices<br />
(instruments)<br />
• Add device identifier to domain