Update/Change information was extracted from Pinnacle21 Webinar about "Exploring Changes in SDTMIG 3.4 & ADaMIG1.3"
Domain Changes
| Change Type | Document | Domain | Class | Comment | Volunteer Review | Presentation Date |
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| Add | SDTM-IG 3.4 | BE | Biospecimen Events | from SDTMIG-PGx |
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| Add | SDTM-IG 3.4 | BS | Biospecimen Findings | from SDTMIG-PGx |
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| Add | SDTM-IG 3.4 | RELSPEC | Related Specimens | from SDTMIG-PGx |
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| Add | SDTM-IG 3.4 | GF | Genomics Findings | replaces PF from SDTMIG-PGx |
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| Add | SDTM-IG 3.4 | CP | Cell Phenotype Findings |
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| 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 |
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| Remove | SDTM-IG 3.4 | MO | Morphology | Domain Decomissioned |
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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 |
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| Update | SDTM-IG 3.4 | DA | Drug Accountability | Product Acccountability |
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| Update | SDTM-IG 3.4 | TS | Trial Summary Information | Trial Summary |
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| Update | SDTM-IG 3.4 | ?? |
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| Update | SDTM-IG 3.4 | ?? |
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| Update | SDTM-IG 3.4 | ?? |
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Structural definition changes
| Change Type | Document | Domain | Domain Structure in SDTM-IG 3.3 | Domain Structure in SDTM-IG 3.4 | Comment |
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| structural update | SDTM-IG 3.4 | DA | One record per drug accountability finding per subject | One record per product accountability finding per subject |
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| structural update | SDTM-IG 3.4 | SC | One record per characteristic per subject | One record per characteristic per visit per subject |
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| structural update | SDTM-IG 3.4 | SS | One record per finding per visit per subject | One record per status per visit per subject |
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| structural update | SDTM-IG 3.4 | SV | One record per subject per actual visit | One record per actual or planned visit per subject |
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| 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 |
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| 1 | Add | Model 2.0 | --BDAGNT | Binding Agent | Variable Qualifier | Perm | Findings |
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| 2 | Add | Model 2.0 | --CLSIG | Clinically Significant, Collected | Record Qualifier | Perm | Findings |
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| 3 | Add | Model 2.0 | --CNDAGT | Test Condition Agent | Record Qualifier | Perm | Findings |
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| 4 | Add | Model 2.0 | --CNTMOD | Contact Mode | Record Qualifier | Perm | Interventions, Events , Findings, SV |
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| 5 | Add | Model 2.0 | --COLSRT | Collected Summary Result Type | Record Qualifier | Perm | Findings |
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| 6 | Add | Model 2.0 | --EPCHGI | Epi/Pandemic Related Change Indicator | Record Qualifier | Perm | Interventions, Events , Findings, SV |
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| 7 | Add | Model 2.0 | --LLOD | Lower Limit of Detection | Variable Qualifier | Perm | Findings |
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| 8 | Add | Model 2.0 | --PDUR | Planned Duration | Timing | Perm | All Classes |
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| 9 | Add | Model 2.0 | --PTFL | Point in Time Flag | Timing | Perm | All Classes |
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| 0 | Add | Model 2.0 | --REASOC | Reasons for Occur Value | Record Qualifier | Perm | Interventiones, Events, SV |
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| 11 | Add | Model 2.0 | --RESSCL | Result Scale | Record Qualifier | Perm | Findings |
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| 12 | Add | Model 2.0 | --RESTYP | Result Type | Record Qualifier | Perm | Findings |
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| 13 | Add | Model 2.0 | --RLDEV | Relationship of Event to Device | Record Qualifier | Perm | Events |
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| 14 | Add | Model 2.0 | --TMTHSN | Test Method Sensitivity | Record Qualifier | Perm | Findings |
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| 15 | Add | Model 2.0 | --TSTCND | Test Condition | Variable Qualifier | Perm | Findings |
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| 16 | Add | Model 2.0 | --TSTOPO | Test Operational Objective | Variable Qualifier | Perm | Findings |
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New Variables for single domains (30)
| # | Domain | Variable Name | Variable Label | Role | Core | Comment | Volunteer Review | Presentation Date |
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| 1 | AE | AESINTV | Needs Intervention to Prevent Impairment | Record Qualifier | Perm | AE domain only |
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| 2 | AE | AEUNANT | Unanticipated Adverse Device Effect | Record Qualifier | Perm | AE domain only |
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| 3 | AE | AERLPRT | Rel of AE to Non-Dev-Rel Study Activity | Record Qualifier | Perm | AE domain only |
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| 4 | AE | AERLPRC | Rel of AE to Device-Related Procedure | Record Qualifier | Perm | AE domain only |
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| 5 | CP | CPSBMRKS | Sublineage Marker String | Record Qualifier | Perm | CP domain only |
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| 6 | CP | CPCELSTA | Cell State | Record Qualifier | Perm | CP domain only |
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| 7 | CP | CPCSMRKS | Cell State Marker String | Variable Qualifier | Perm | CP domain only |
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| 8 |
Timing0 | | CP | CPABCLID | Antibody Clone Identifier | Record Qualifier | Perm | CP domain only |
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| 9 |
Timing | Perm | | CP | CPMRKSTR | Marker String | Record Qualifier | Exp | CP domain only |
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| 0 | CP | CPGATE | Gate |
| Record Qualifier | Perm | CP domain only |
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| 11 | CP | CPGATDEF | Gate Definition | Record Qualifier | Perm | CP domain only |
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| 12 | CP | CPSPTSDT | Sponsor Test Description | Record Qualifier | Perm | CP domain only |
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| 13 |
| CP | CPTSTPNL | Test Panel | Grouping |
Record | Qualifier | Perm | CP domain only |
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| 14 | DM | RFCSTDTC | Date/Time of First Challenge Agent Admin | Record Qualifier | Perm | DM only |
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| 15 |
| DM | RFCENTC | Date/Time of Last Challenge Agent Admin | Record |
Variable | Qualifier | Perm | DM only |
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| 16 | GF | GFINHERT | Inheritability | Variable Qualifier | Perm |
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| 17 |
| GF | GFGENREF | Genome Reference | Variable |
Record | GF | GFCHROM | Chromosome Identifier | Variable |
Record | Qualifier | Perm |
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| 19 | GF | GFSYM | Genomic Symbol | Record Qualifier | Perm |
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| 20 | GF | GFSYMTYP | Genomic Symbol Type | Record Qualifier | Perm |
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| 21 | GF | GFGENLOC | Genetic Location | Record Qualifier | Perm |
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| 22 |
| GF | GFGENSR | Genetic Sub-Region | Record |
Variable | GF | GFSEQID | Sequence Identifier \n | Record Qualifier |
Timing | GF | GFPVRID | Published Variant Identifier | Record Qualifier |
Timing | Perm |
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| 25 | GF | GFCOPYID | Copy Identifier | Record Qualifier | Perm |
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| 62 |
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| Record Qualifier | Perm |
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| 27 |
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| Record Qualifier | Perm |
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| 28 |
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| Record Qualifier | Perm |
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| 29 |
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| Record Qualifier | Perm |
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| 30 |
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| Variable Qualifier | Perm |
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> Variables in Model but not used in SDTM-IG
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