Implications for SDTM

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

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Questions to Ponder

• Prior to these documents, a case could be made

for using “pure” SDTM as an internal data

standard. Is that still a valid strategy? If not,

what should the new strategy be?

• How will our processes need to change to

support production of the new SDTM?

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Questions to Ponder • Prior to these documents, a case could be made for using “pure” SDTM as an internal data standard. Is that still a valid strategy? If not, what should the new strategy be? • How will our processes need to change to support production of the new SDTM? 14

Thank you! Questions? John Brega: JBrega@PharmaStat.com 15

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 and 10: New DM Variables Variable Name Vari
Page 11 and 12: More SDTM Specifics • Include EPO

Implications for SDTM

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