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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 | |||
| 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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| # | Var Name | Var Label | Type | CT/Format | Role | Core | Included in IG | Volunteer | Presentation Date |
| 1 | --ACNDEV | Action Taken with Device | Char | (DEACNDEV) | Record Qualifier | Perm | AE domain | ||
| 2 | --ANMETH | Analysis Method | Char | (LBANMET) for LB or (PKANMET) for PP | Record Qualifier | Perm | LB and PP domains | ||
| 3 | --DRVFL | Derived Flag | Char | (NY) | Record Qualifier | Perm | IS domain | ||
| 4 | --ELTM | Planned Elapsed Time from Time Point Ref | Char | ISO8601 duration | Timing | Perm | IS domain | ||
| 5 | --ENDTC | End Date/Time of Specimen Collection | Char | ISO8601 datetime or interval | Timing | Perm | IS domain | ||
| 6 | --ENDY | Study Day of End of Element | Num | Timing | Perm | SE domain | |||
| 7 | --ENDY | Study Day of End of Specimen Collection | Num | Timing | Perm | IS domain | |||
| 8 | --EVINTX | Evaluation Interval Text | Char | Timing | Perm | QS domain | |||
| 9 | --LNKGRP | Link Group ID | Char | Identifier | Perm | DA domain | |||
| 10 | --LNKID | Link ID | Char | Identifier | Perm | DA domain | |||
| 11 | --METHOD | Method of Test or Examination | Char | (QRSMTHOD) | Record Qualifier | Perm | QS and RS domains | ||
| 12 | NHOID | Non-host Organism ID | Char | Identifier | Perm | IS domain | |||
| 13 | --NRIND | Reference Range Indicator | Char | (NRIND) | Variable Qualifier | Exp | IS domain | ||
| 14 | --OCCUR | Occurence | Char | (NY) | Record Qualifier | Exp | SV domain | ||
| 15 | --ORNRHI | Reference Range Upper Limit in Orig Unit | Char | Variable Qualifier | Exp | IS domain | |||
| 16 | --ORNRLO | Reference Range Lower Limit in Orig Unit | Char | Variable Qualifier | Exp | IS domain | |||
| 17 | --PRESP | Pre-specified | Char | (NY) | Variable Qualifier | Exp | SV domain | ||
| 18 | --RFTDTC | Date/time of Reference Time Point | Char | ISO8601 datetime or interval | Timing | Perm | IS domain | ||
| 19 | --SPCCND | Specimen Condition | Char | (SPECCOND) | Record Qualifier | Perm | IS domain | ||
| 20 | --SPCUFL | Specimen Usability for the Test | Char | (NY) | Record Qualifier | Perm | IS domain | ||
| 21 | --SPCUFL | Specimen Usability for the Test | Char | (NY) | Record Qualifier | Perm | LB domain | ||
| 22 | SPDEVID | Sponsor Device Identifier | Char | Identifier | Perm | AE domain | |||
| 23 | --STDY | Study Day of Start of Element | Num | Timing | Perm | SE domain | |||
| 24 | --STNRC | Reference Range for Char Rslt-Std Units | Char | Variable Qualifier | Perm | IS domain | |||
| 25 | --STNRHI | Reference Range Upper Limit-Std Units | Num | Variable Qualifier | Exp | IS domain | |||
| 26 | --STNRLO | Reference Range Lower Limit-Std Units | Num | Variable Qualifier | Exp | IS domain | |||
| 27 | --TOX | Toxicity | Char | Variable Qualifier | Perm | VS domain | |||
| 28 | --TOXGR | Standard Toxicity Grade | Char | Record Qualifier | Perm | CE and VS domains | |||
| 29 | --TPT | Planned Time Point Name | Char | Timing | Perm | IS domain | |||
| 30 | --TPTNUM | Planned Time Point Number | Num | Timing | Perm | IS domain | |||
| 31 | --TPTREF | Time Point Reference | Char | Timing | Perm | IS and PP domains | |||
| 32 | --TSTDTL | Test Detail | Char | Variable Qualifier | Perm | IS domain | |||
| 33 | VISIT | Visit Name | Char | Timing | Perm | SC domain | |||
| 34 | VISITDY | Planned Study Day of Visit | Num | Timing | Perm | SC domain | |||
| 35 | VISITNUM | Visit Number | Num | Timing | Perm | SC domain |
> Variables Expanded Use in SDTM-IG 3.4
2 listed in P21 presentation
| Topic | Details | Volunteer | Presentation Date |
| Variables Expanded Use in SDTM-IG 3.4 | 2 listed in P21 presentation |
> Variables Removed in SDTM-IG 3.4
...
10 variables listed in P21 presentation
| Topic | Details | Volunteer | Presentation Date |
| Variables Label Changes in SDTM-IG 3.4 (compared to 3.3) | 10 variables listed in P21 presentation |
...
7 variables listed in P21 presentation
| Topic | Details | Volunteer | Presentation Date |
| Variables Label Changes in Model 2.0 (compared against 1.8) | 7 variables listed in P21 presentation |
...
> Variables Changes
- ISO8601 udpates
- TSVALNF
| Topic | Details | Volunteer | Presentation Date |
| Variables Changes | ISO8601 udpates TSVALNF |
> Variables Codelist Assignments Changes in SDTM-IG 3.4
21 variables listed in P21 presentation
| Topic | Details | Volunteer | Presentation Date |
| Variables Codelist Assignments Changes in SDTM-IG 3.4 | 21 variables listed in P21 presentation |
...
+ 1 Role value correction in SDTM-IG 3.4
| Topic | Details | Volunteer | Presentation Date |
| Variable Role values changed in Model 2.0 | 10 variables listed in P21 presentation (3 inconsistencies now between Model 2.0 and IG3.4) + 1 Role value correction in SDTM-IG 3.4 |
...
7 variables listed in P21 presentation
| Topic | Details | Volunteer | Presentation Date |
| Variable Core values changed in SDTM-IG 3.4 | 7 variables listed in P21 presentation |
...
2 variables listed in P21 presentation
| Topic | Details | Volunteer | Presentation Date |
| Variable order changed in SDTM-IG 3.4 | 2 variables listed in P21 presentation |
...
8 domains listed in P21 presentation
| Topic | Details | Volunteer | Presentation Date |
| Assumptions for domains changed in SDTM-IG 3.4 | 8 domains listed in P21 presentation |
...
20 Role inconsistencies listed in P21 presentation
| Topic | Details | Volunteer | Presentation Date |
| Inconsistencies between Model 2.0 and SDTM-IG 3.4 | 20 Role inconsistencies listed in P21 presentation |
...