Implications for SDTM

CDER Common Data Standards Issues Document ... - CDISC Portal

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More SDTM Specifics

• Include EPOCH, ELEMENT and ETCD in every

“subject-level” dataset (e.g., AE, LB, CM, EX, VS…)

• Split large datasets by --CAT, include both the

split and the complete datasets

– How big is “large”? Up to 400mb is OK, but ask your

review division

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

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

Six New SDTM Domains for Medical Devices

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

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

Brief Pain Inventory Short Form (BPI Short Form)

The SDTM Specifics: DS • Use EPOCH in DS to distinguish multiple disposition events • If DEATH occurs it’s the last record and has an EPOCH 10

More SDTM Specifics • Include EPOCH, ELEMENT and ETCD in every “subject-level” dataset (e.g., AE, LB, CM, EX, VS…) • Split large datasets by --CAT, include both the split and the complete datasets – How big is “large”? Up to 400mb is OK, but ask your review division 11

Page 1 and 2: CDER Common Data Standards Issues D
Page 3 and 4: The Documents • CDER published th
Page 5 and 6: CDER’s Rules of Thumb • Submit
Page 7 and 8: New Events Variables Variable Name
Page 9: New DM Variables Variable Name Vari
Page 14 and 15: Questions to Ponder • Prior to th

Implications for SDTM

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