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 | Volunteer | Presentation Date |
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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 | More impact, check also details in new variable |
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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 |
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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 |
Timing | CP | CPABCLID | Antibody Clone Identifier | Record Qualifier | Perm | CP domain only |
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Timing | Perm | CP | CPMRKSTR | Marker String | Record Qualifier | Exp | CP domain only |
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0 | CP | CPGATE | Gate |
0 | 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 |
Record CP | CPTSTPNL | Test Panel | Grouping 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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Variable DM | RFCENTC | Date/Time of Last Challenge Agent Admin | Record Qualifier | Perm | DM only |
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16 | GF | GFINHERT | Inheritability | Variable Qualifier | Perm | GF only |
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Record GF | GFGENREF | Genome Reference | Variable Qualifier | Perm | GF only |
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18 |
| GF | GFCHROM | Chromosome Identifier | Variable |
Record Record GF | GFSYM | Genomic Symbol | Variable Qualifier | Perm | GF only |
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20 |
Record GF | GFSYMTYP | Genomic Symbol Type | Variable Qualifier | Perm | GF only |
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21 |
Record GF | GFGENLOC | Genetic Location | Variable Qualifier | Perm | GF only |
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22 | GF | GFGENSR | Genetic Sub-Region | Variable Qualifier | Perm | GF only |
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23 |
| GF | GFSEQID | Sequence Identifier \n | Variable Qualifier |
Timing | GF | GFPVRID | Published Variant Identifier | Variable Qualifier |
Timing | GF | GFCOPYID | Copy Identifier | Variable |
Record 62 | GF only |
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26 | IS | ISMSCBCE | Molecule Secretet by Cells | Variable |
Record Record Qualifier | | RELSPEC | REFID | Specimen ID | Identifier | Req |
PermRecord RELSPEC | SPEC | Specimen Type | Variable Qualifier | Perm |
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29 |
Record Qualifier | RELSPEC | PARENT | Specimen Parent | Identifier | Exp |
Perm |
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30 | RELSPEC | LEVEL | Specimen Level | Variable Qualifier |
Perm
> Variables in Model but not used in SDTM-IG
11 listed in P21 Presentation
Var Name | Var Label | Type | CT/Format | Role | Observation Class | Usage restrictions | SDTM Model | Volunteer | Presentation Date |
--REASPF | Reason Test Performed | Char |
| Record Qualifier | Findings |
| Introduced in SDTM v2.0 |
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--CHDY | Day of Obs Rel to Challenge Agent | Num |
| Timing | All Classes |
| Introduced in SDTM v1.8 |
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--CHSTDY | Start Day of Obs Rel to Challenge Agent | Num |
| Timing | All Classes | Not in Findings class domains | Introduced in SDTM v1.8 |
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--CHENDY | End Day of Obs Rel to Challenge Agent | Num |
| Timing | All Classes |
| Introduced in SDTM v1.8 |
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--FTDOSD | Factor for Toxic/Physiologic Dose Descr | Num |
| Variable Qualifier | Interventions |
| Introduced in SDTM v1.8 |
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--TDOSD | Toxic/Physiologic Dose Descr | Char |
| Record Qualifier | Interventions |
| Introduced in SDTM v1.8 |
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--XDY | Day of Obs Relative to Exposure | Num |
| Timing | All Classes |
| Introduced in SDTM v1.8 |
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--XSTDY | Start Day of Obs Relative to Exposure | Num |
| Timing | All Classes | Not in Findings class domains | Introduced in SDTM v1.8 |
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--XENDY | End Day of Obs Relative to Exposure | Num |
| Timing | All Classes |
| Introduced in SDTM v1.8 |
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--RSTIND | Restraint Indicator | Char |
| Record Qualifier | Interventions, Findings | Not in human clinical trials | Introduced in SDTM v1.8 |
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--RSTMOD | Restraint Mode | Char |
| Record Qualifier | Interventions, Findings | Not in human clinical trials | Introduced in SDTM v1.8 |
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> Existing Permissible Variables added to SDTM-IG...
35 variables listed in P21 presentation...
# | 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 |
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2 | --ANMETH | Analysis Method | Char | (LBANMET) for LB or (PKANMET) for PP | Record Qualifier | Perm | LB and PP domains |
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3 | --DRVFL | Derived Flag | Char | (NY) | Record Qualifier | Perm | IS domain |
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4 | --ELTM | Planned Elapsed Time from Time Point Ref | Char | ISO8601 duration | Timing | Perm | IS domain |
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5 | --ENDTC | End Date/Time of Specimen Collection | Char | ISO8601 datetime or interval | Timing | Perm | IS domain |
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6 | --ENDY | Study Day of End of Element | Num |
| Timing | Perm | SE domain |
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7 | --ENDY | Study Day of End of Specimen Collection | Num |
| Timing | Perm | IS domain |
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8 | --EVINTX | Evaluation Interval Text | Char |
| Timing | Perm | QS domain |
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9 | --LNKGRP | Link Group ID | Char |
| Identifier | Perm | DA domain |
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10 | --LNKID | Link ID | Char |
| Identifier | Perm | DA domain |
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11 | --METHOD | Method of Test or Examination | Char | (QRSMTHOD) | Record Qualifier | Perm | QS and RS domains |
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12 | NHOID | Non-host Organism ID | Char |
| Identifier | Perm | IS domain |
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13 | --NRIND | Reference Range Indicator | Char | (NRIND) | Variable Qualifier | Exp | IS domain |
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14 | --OCCUR | Occurence | Char | (NY) | Record Qualifier | Exp | SV domain |
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15 | --ORNRHI | Reference Range Upper Limit in Orig Unit | Char |
| Variable Qualifier | Exp | IS domain |
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16 | --ORNRLO | Reference Range Lower Limit in Orig Unit | Char |
| Variable Qualifier | Exp | IS domain |
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17 | --PRESP | Pre-specified | Char | (NY) | Variable Qualifier | Exp | SV domain |
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18 | --RFTDTC | Date/time of Reference Time Point | Char | ISO8601 datetime or interval | Timing | Perm | IS domain |
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19 | --SPCCND | Specimen Condition | Char | (SPECCOND) | Record Qualifier | Perm | IS domain |
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20 | --SPCUFL | Specimen Usability for the Test | Char | (NY) | Record Qualifier | Perm | IS domain |
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21 | --SPCUFL | Specimen Usability for the Test | Char | (NY) | Record Qualifier | Perm | LB domain |
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22 | SPDEVID | Sponsor Device Identifier | Char |
| Identifier | Perm | AE domain |
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23 | --STDY | Study Day of Start of Element | Num |
| Timing | Perm | SE domain |
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24 | --STNRC | Reference Range for Char Rslt-Std Units | Char |
| Variable Qualifier | Perm | IS domain |
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25 | --STNRHI | Reference Range Upper Limit-Std Units | Num |
| Variable Qualifier | Exp | IS domain |
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26 | --STNRLO | Reference Range Lower Limit-Std Units | Num |
| Variable Qualifier | Exp | IS domain |
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27 | --TOX | Toxicity | Char |
| Variable Qualifier | Perm | VS domain |
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28 | --TOXGR | Standard Toxicity Grade | Char |
| Record Qualifier | Perm | CE and VS domains |
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29 | --TPT | Planned Time Point Name | Char |
| Timing | Perm | IS domain |
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30 | --TPTNUM | Planned Time Point Number | Num |
| Timing | Perm | IS domain |
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31 | --TPTREF | Time Point Reference | Char |
| Timing | Perm | IS and PP domains |
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32 | --TSTDTL | Test Detail | Char |
| Variable Qualifier | Perm | IS domain |
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33 | VISIT | Visit Name | Char |
| Timing | Perm | SC domain |
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34 | VISITDY | Planned Study Day of Visit | Num |
| Timing | Perm | SC domain |
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35 | VISITNUM | Visit Number | Num |
| Timing | Perm | SC domain |
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> 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 |
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> Variables Removed in SDTM-IG 3.4
15 listed in P21 presentation
+ one which is reduced now to Associated Persons domains only (APID)
# | Domain | Var Name | Var Label | Type | CT (old) | Role | Core (old) | Usage restrictions (new) | IG Assumptions/Revision history | Volunteer | Presentation Date |
1 | FT | FTEVAL | Evaluator | Char | (EVAL) | Record Qualifier | Perm | Not in QS, FT and clinical classifications use case of RS | "--EVAL and -_EVALID must not beused to model QRS data in SDTM… If needed, supplemental qualifiers may be used to represent this data." |
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2 | LB | LBSTREFC | Reference Result in Standard Format | Char |
| Variable Qualifier | Exp |
| "Revised Core value for LBSTREFC to Perm (from Exp)." and "LBORREF, LBSTREFC, and LBSTREFN were removed because there is no clear use case." |
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3 | MS | MSENDTC | End Date/Time of Observation | Num |
| Timing | Perm |
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4 | MS | MSENDY | Study Day of End of Observation | Num |
| Timing | Perm |
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5 | MS | MSENRF | End Relative to Reference Period | Char | (STENRF) | Timing | Perm |
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6 | MS | MSENRTPT | End Relative to Reference Time Point | Char | (STENRF) | Timing | Perm |
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7 | MS | MSENTPT | End Reference Time Point | Char |
| Timing | Perm |
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8 | MS | MSMODIFY | Modified Reported Name | Char |
| Synonym Qualifier | Perm |
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9 | MS | MSSPCUFL | Specimen Usability for the Test | Char | (NY) | Record Qualifier | Perm |
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10 | MS | MSSTRF | Start Relative to Reference Period | Char | (STENRF) | Timing | Perm |
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11 | MS | MSSTRTPT | Start Relative to Reference Time Point | Char | (STENRF) | Timing | Perm |
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12 | MS | MSSTTPT | Start Reference Time Point | Char |
| Timing | Perm |
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13 | QS | QSEVAL | Evaluator | Char | (EVAL) | Record Qualifier | Perm | Not in QS, FT, and clinical classifications use case of RS |
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14 | UR | URSPCUFL | Specimen Usability for the Test | Char | (NY) | Record Qualifier | Perm |
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15 | UR | URSPEC | Specimen Material Type | Char | (SPECTYPE) | Record Qualifier | Perm |
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> Variables Label Changes in SDTM-IG 3.4 (compared to 3.3)
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 |
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> Variables Label Changes in Model 2.0 (compared against 1.8)
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 |
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> Variables Changes
Topic | Details | Volunteer | Presentation Date |
Variables Changes | ISO8601 udpates TSVALNF |
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> 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 |
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> 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
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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 |
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and IG3.4)
+ 1 Role value correction in SDTM-IG 3.4 |
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> Variable Core values changed in SDTM-IG 3.4
7 variables listed in P21 presentation
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Topic | Details | Volunteer | Presentation Date |
Variable Core values changed in SDTM-IG 3.4 | 7 variables listed in P21 presentation |
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> Variable order changed in SDTM-IG 3.4
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 |
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> Assumptions for domains changed in SDTM-IG 3.4
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 |
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> Inconsistencies between Model 2.0 and SDTM-IG 3.4
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 |
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> Conformance Rule V2.0 - changes...
3 Conf Rules removed (for 3.2 and 3.3)
...