Six New SDTM Domains for Medical Devices

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CDISC • Examples of differences (CRF analysis): • AE -> 1 AE associated with multiple devices • Being worked on by SDS team (also applies to multiple drugs) • AE -> Relationship to multiple devices • Being worked on by Terminology team
CDISC • Examples of differences (CRF analysis): • AE -> <strong>for</strong> lab operators (not subjects) • Non-subject data domains under development • DV -> Protocol deviations <strong>for</strong> devices (instruments) • Add device identifier to domain
Page 1 and 2: Six New SDTM Domains for Medical De
Page 3 and 4: Setting the Stage • Blood screeni
Page 5 and 6: Setting the Stage • Classificatio
Page 7: Setting the Stage • Examples of r
Page 10 and 11: Setting the Stage • Most submissi
Page 12 and 13: Setting the Stage • The Device su
Page 16 and 17: CDISC • Public Review of these 6
Page 18 and 19: CDISC • Two new variables will be
Page 20: CONTACT INFORMATION Carey G. Smoak

Six New SDTM Domains for Medical Devices

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