Six New SDTM Domains for Medical Devices

Carey Smoak - CDISC Portal

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Setting the Stage

• Classification of Devices

• intended use of the device and also upon

indications for use

• Class I – minimal risk to the user

• enemas, crutches, elastic bandages, bedpans

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Screener and Opioid Assessment for Patients with Pain- Revised (SOAPP -R)

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Modified Hachinski Ischemic Scale NACC Version (MHIS-NACC) v.1.0

Brief Pain Inventory Short Form (BPI Short Form)

Setting the Stage • Devices are used in combination with pharmaceutical products: • Drug-eluting heart stents • Companion diagnostics and targeted therapies

Setting the Stage • Classification of Devices • intended use of the device and also upon indications for use • Class I – minimal risk to the user • enemas, crutches, elastic bandages, bedpans

Page 1 and 2: Six New SDTM Domains for Medical De
Page 3: Setting the Stage • Blood screeni
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 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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