Six New SDTM Domains for Medical Devices

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CDISC • Public Review of these 6 SDTM domains • Device Information • Device In-Use Properties • Device Subject-Relationship • Device Events • Device Exposure • Device Tracking and Disposition
Device Domains ER Diagram Device Specifications (Generic) Device Deployment With or Without Subject Contact (Specific Device) Device In Use Properties DU Device Contact with Subjects (Specific Device) Image Generation*? Image Results Subject-Device Relationships DR Demographics Device Information DI Device Tracking & Disposition DT Device Exposure DX Subject Exposure * Device Events DE Adverse Events * Subject Disposition Domain Capturing Device-Related Data Device Domains Specifically for Imaging Clinical Domains * Domain not developed yet or not yet customized for Device trials Version September 2011
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 14 and 15: CDISC • Examples of differences (
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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