Implications for SDTM

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The SDTM Specifics: DM • 8 new variables are added: – Actual Arm and Arm Code – Dates of First and Last Study Treatment Exposure – Dates of Informed Consent and End of Participation – Date of Death and Subject Death Flag • Some may be redundant with RFSTDTC or RFENDTC • All are Required or Expected 8
New DM Variables Variable Name Variable Label Type Controlled Terms, Codelist or Format ACTARMCD Actual Arm Code Char * ACTARM D Actual Arm Char * RFXSTDTC Date/Time of First Study Treatment Exposure Char ISO 8601 RFXENDTC Date/Time of Last Study Treatment Exposure Char ISO 8601 RFICDTC Date/Time of Informed Consent Char ISO 8601 RFPENDTC Date/Time of End of Participation Char ISO 8601 DTHDTC Date of Death Char ISO 8601 DTHFL Subject Death Flag Char (NY) *Note that labels are too long for two of the variables… 9
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: New Events Variables Variable Name
Page 11 and 12: More SDTM Specifics • Include EPO
Page 14 and 15: Questions to Ponder • Prior to th

Implications for SDTM

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