Six New SDTM Domains for Medical Devices

Carey Smoak - CDISC Portal

ePAPER READ

DOWNLOAD ePAPER

digitalinfuzion.com

You also want an ePaper? Increase the reach of your titles

YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.

START NOW

Setting the Stage

• The Device sub-team is a cooperative

effort between:

• CDRH and CBER at the FDA

• Industry experts

• Members of the CDISC CDASH/SDS teams

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

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

Hamilton Depression Rating Scale 21-Item (HAMD 21)

SDTM Metadata Repositories Governance Versioning i

Hamilton Depression Rating Scale 17-Item (HAMD 17)

the Gray Areas Trickier Concepts and Beyond

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

Setting the Stage • The Device sub-team is a cooperative effort between: • CDRH and CBER at the FDA • Industry experts • Members of the CDISC CDASH/SDS teams

CDISC • CRF Analysis of 138 CRFs from various device companies • Compared to CDASH domains • Identified differences • Recommended solutions

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 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

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?