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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Setting the Stage<br />

• Blood screening devices keep blood supply<br />

safe<br />

• Heart stents save peoples’ lives

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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

the Gray Areas Trickier Concepts and Beyond

Hamilton Depression Rating Scale 17-Item (HAMD 17)

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)

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

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

OVERVIEW • Introduction • Setting the Stage • 6 <strong>New</strong> <strong>SDTM</strong> <strong>Domains</strong> <strong>for</strong> <strong>Devices</strong> • Conclusion

Setting the Stage • Blood screening devices keep blood supply safe • Heart stents save peoples’ lives

Page 1: Six New SDTM Domains for Medical De
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 18 and 19: CDISC • Two new variables will be
Page 20: CONTACT INFORMATION Carey G. Smoak