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| Change Type | Document | Domain | Domain Structure in SDTM-IG 3.3 | Domain Structure in SDTM-IG 3.4 | Comment | Volunteer | Presentation Date |
|---|---|---|---|---|---|---|---|
| structural update | SDTM-IG 3.4 | DA | One record per drug accountability finding per subject | One record per product accountability finding per subject | |||
| structural update | SDTM-IG 3.4 | SC | One record per characteristic per subject | One record per characteristic per visit per subject | |||
| structural update | SDTM-IG 3.4 | SS | One record per finding per visit per subject | One record per status per visit per subject | |||
| structural update | SDTM-IG 3.4 | SV | One record per subject per actual visit | One record per actual or planned visit per subject | More impact, check also details in new variable | ||
| structural update | SDTM-IG 3.4 | TI | One record per I/E crierion | One record per I/E criterion | typo in criterion |
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