Domain Changes
| Change Type | Document | Domain | Class | Comment | Volunteer Review | Presentation Date |
|---|---|---|---|---|---|---|
| Add | SDTM-IG 3.4 | BE | Biospecimen Events | from SDTMIG-PGx | ||
| Add | SDTM-IG 3.4 | BS | Biospecimen Findings | from SDTMIG-PGx | ||
| Add | SDTM-IG 3.4 | RELSPEC | Related Specimens | from SDTMIG-PGx | ||
| Add | SDTM-IG 3.4 | GF | Genomics Findings | replaces PF from SDTMIG-PGx | ||
| Add | SDTM-IG 3.4 | CP | Cell Phenotype Findings | |||
| Add | Model 2.0 | RELSPEC | Related Specimens | n/a | n/a | |
| Add | Model 1.8 (SEND-IG) | AC | Challenge Agent Characterization | Only for nonclinical Animal Rule studies | ||
| Remove | SDTM-IG 3.4 | MO | Morphology | Domain Decomissioned |
Label Changes (total of 5 label changes for domains?)
| Change Type | Document | Domain | Label in SDTM-IG 3.3 | Label in SDTM-IG 3.4 | Comment |
|---|---|---|---|---|---|
| Update | SDTM-IG 3.4 | DA | Drug Accountability | Product Acccountability | |
| Update | SDTM-IG 3.4 | TS | Trial Summary Information | Trial Summary | |
| Update | SDTM-IG 3.4 | ?? | |||
| Update | SDTM-IG 3.4 | ?? | |||
| Update | SDTM-IG 3.4 | ?? | |||
Structural definition changes
| Change Type | Document | Domain | Domain Structure in SDTM-IG 3.3 | Domain Structure in SDTM-IG 3.4 | Comment |
|---|---|---|---|---|---|
| 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 |
Variable changes multiple domains (16)
| # | Change Type | Document | Variable Name | Variable Label | Role | Core | Observation Class | Comment | Volunteer Review | Presentation Date |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | Add | Model 2.0 | --BDAGNT | Binding Agent | Variable Qualifier | Perm | Findings | |||
| 2 | Add | Model 2.0 | --CLSIG | Clinically Significant, Collected | Record Qualifier | Perm | Findings | |||
| 3 | Add | Model 2.0 | --CNDAGT | Test Condition Agent | Record Qualifier | Perm | Findings | |||
| 4 | Add | Model 2.0 | --CNTMOD | Contact Mode | Record Qualifier | Perm | Interventions, Events , Findings, SV | |||
| 5 | Add | Model 2.0 | --COLSRT | Collected Summary Result Type | Record Qualifier | Perm | Findings | |||
| 6 | Add | Model 2.0 | --EPCHGI | Epi/Pandemic Related Change Indicator | Record Qualifier | Perm | Interventions, Events , Findings, SV | |||
| 7 | Add | Model 2.0 | --LLOD | Lower Limit of Detection | Variable Qualifier | Perm | Findings | |||
| 8 | Add | Model 2.0 | --PDUR | Planned Duration | Timing | Perm | All Classes | |||
| 9 | Add | Model 2.0 | --PTFL | Point in Time Flag | Timing | Perm | All Classes | |||
| 0 | Add | Model 2.0 | --REASOC | Reasons for Occur Value | Record Qualifier | Perm | Interventiones, Events, SV | |||
| 11 | Add | Model 2.0 | --RESSCL | Result Scale | Record Qualifier | Perm | Findings | |||
| 12 | Add | Model 2.0 | --RESTYP | Result Type | Record Qualifier | Perm | Findings | |||
| 13 | Add | Model 2.0 | --RLDEV | Relationship of Event to Device | Record Qualifier | Perm | Events | |||
| 14 | Add | Model 2.0 | --TMTHSN | Test Method Sensitivity | Record Qualifier | Perm | Findings | |||
| 15 | Add | Model 2.0 | --TSTCND | Test Condition | Variable Qualifier | Perm | Findings | |||
| 16 | Add | Model 2.0 | --TSTOPO | Test Operational Objective | Variable Qualifier | Perm | Findings |
New Variables for single domains (30)
| # | Domain | Variable Name | Variable Label | Role | Core | Comment | Volunteer Review | Presentation Date |
|---|---|---|---|---|---|---|---|---|
| 1 | AE | AESINTV | Needs Intervention to Prevent Impairment | Record Qualifier | Perm | |||
| 2 | AE | AEUNANT | Unanticipated Adverse Device Effect | Record Qualifier | Perm | |||
| 3 | AE | AERLPRT | Rel of AE to Non-Dev-Rel Study Activity | Record Qualifier | Perm | |||
| 4 | AE | AERLPRC | Rel of AE to Device-Related Procedure | Record Qualifier | Perm | |||
| 5 | CP | CPSBMRKS | Sublineage Marker String | Record Qualifier | Perm | |||
| 6 | CP | CPCELSTA | Cell State | Record Qualifier | Perm | |||
| 7 | CP | CPCSMRKS | Cell State Marker String | Variable Qualifier | Perm | |||
| 8 | Timing | Perm | ||||||
| 9 | Timing | Perm | ||||||
| 0 | Record Qualifier | Perm | ||||||
| 11 | Record Qualifier | Perm | ||||||
| 12 | Record Qualifier | Perm | ||||||
| 13 | Record Qualifier | Perm | ||||||
| 14 | Record Qualifier | Perm | ||||||
| 15 | Variable Qualifier | Perm | ||||||
| 16 | Variable Qualifier | Perm | ||||||
| 17 | Record Qualifier | Perm | ||||||
| 18 | Record Qualifier | Perm | ||||||
| 19 | Record Qualifier | Perm | ||||||
| 20 | Record Qualifier | Perm | ||||||
| 21 | Record Qualifier | Perm | ||||||
| 22 | Variable Qualifier | Perm | ||||||
| 23 | Timing | Perm | ||||||
| 24 | Timing | Perm | ||||||
| 25 | Record Qualifier | Perm | ||||||
| 62 | Record Qualifier | Perm | ||||||
| 27 | Record Qualifier | Perm | ||||||
| 28 | Record Qualifier | Perm | ||||||
| 29 | Record Qualifier | Perm | ||||||
| 30 | Variable Qualifier | Perm | ||||||
> Variables in Model but not used in SDTM-IG
11 listed in P21 Presentation
> Existing Permissible Variables added to SDTM-IG...
35 variables listed in P21 presentation...
> Variables Expanded Use in SDTM-IG 3.4
2 listed in P21 presentation
> Variables Removed in SDTM-IG 3.4
15 listed in P21 presentation
+ one which is reduced now to Associated Persons domains only (APID)
> Variables Label Changes in SDTM-IG 3.4 (compared to 3.3)
10 variables listed in P21 presentation
> Variables Label Changes in Model 2.0 (compared against 1.8)
7 variables listed in P21 presentation
> Variables Changes
- ISO8601 udpates
- TSVALNF
> Variables Codelist Assignments Changes in SDTM-IG 3.4
21 variables listed in P21 presentation
> 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
> Variables Label Changes in Model 2.0 (compared against 1.8)
7 variables listed in P21 presentation
> Variable Core values changed in SDTM-IG 3.4
7 variables listed in P21 presentation
> Variable order changed in SDTM-IG 3.4
2 variables listed in P21 presentation
> Assumptions for domains changed in SDTM-IG 3.4
8 domains listed in P21 presentation
> Inconsistencies between Model 2.0 and SDTM-IG 3.4
20 Role inconsistencies listed in P21 presentation
#####################
> Conformance Rule V2.0 - changes...
3 Conf Rules removed (for 3.2 and 3.3)
4 Conf Rules added (for 3.2 and 3.3)
59 New conformance rules added for SDTM-IG 3.4 listed in P21 presentation
25 existing Conf Rule have a Rule Version change