Six New SDTM Domains for Medical Devices

05.09.2015 • Views

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Six New SDTM Domains for Medical Devices

Carey Smoak - CDISC Portal

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CDISC<br />

• Two new variables will be needed:<br />

• Generic device identifiers<br />

• Unique device identifiers

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Using ODM Messages to Integrate Clinical Trial Systems and Improve Data Quality

define.xml.v2 row-level metadata

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

Study Data Reviewer’s Guide

Hamilton Depression Rating Scale 21-Item (HAMD 21)

Trial Design Domains

SDTM Metadata Repositories Governance Versioning i

Hamilton Depression Rating Scale 17-Item (HAMD 17)

the Gray Areas Trickier Concepts and Beyond

Hamilton Depression Rating Scale 17-Item (HAMD 17)

ADAS_COG v1 85pt Detailed Annotated CRF.pdf - CDISC Portal

Brief Pain Inventory Short Form (BPI Short Form)

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

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

CDISC • Two new variables will be needed: • Generic device identifiers • Unique device identifiers

CONCLUSION • 6 <strong>New</strong> <strong>SDTM</strong> Device domains are almost ready <strong>for</strong> public review!

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 16 and 17: CDISC • Public Review of these 6
Page 20: CONTACT INFORMATION Carey G. Smoak