SDTM-IG 3.3/-Model 1.7 to SDTM-IG 3.4/-Model 2.0 changes...

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
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
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
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
1	AE	AESINTV	Needs Intervention to Prevent Impairment	Record Qualifier	Perm	AE domain only
2	AE	AEUNANT	Unanticipated Adverse Device Effect	Record Qualifier	Perm	AE domain only
3	AE	AERLPRT	Rel of AE to Non-Dev-Rel Study Activity	Record Qualifier	Perm	AE domain only
4	AE	AERLPRC	Rel of AE to Device-Related Procedure	Record Qualifier	Perm	AE domain only
5	CP	CPSBMRKS	Sublineage Marker String	Record Qualifier	Perm	CP domain only
6	CP	CPCELSTA	Cell State	Record Qualifier	Perm	CP domain only
7	CP	CPCSMRKS	Cell State Marker String	Variable Qualifier	Perm	CP domain only
8	CP	CPABCLID	Antibody Clone Identifier	Record Qualifier	Perm	CP domain only
9	CP	CPMRKSTR	Marker String	Record Qualifier	Exp	CP domain only
0	CP	CPGATE	Gate	Record Qualifier	Perm	CP domain only
11	CP	CPGATDEF	Gate Definition	Record Qualifier	Perm	CP domain only
12	CP	CPSPTSDT	Sponsor Test Description	Record Qualifier	Perm	CP domain only
13	CP	CPTSTPNL	Test Panel	Grouping Qualifier	Perm	CP domain only
14	DM	RFCSTDTC	Date/Time of First Challenge Agent Admin	Record Qualifier	Perm	DM only
15	DM	RFCENTC	Date/Time of Last Challenge Agent Admin	Record Qualifier	Perm	DM only
16	GF	GFINHERT	Inheritability	Variable Qualifier	Perm	GF only
17	GF	GFGENREF	Genome Reference	Variable Qualifier	Perm	GF only
18	GF	GFCHROM	Chromosome Identifier	Variable Qualifier	Perm	GF only
19	GF	GFSYM	Genomic Symbol	Variable Qualifier	Perm	GF only
20	GF	GFSYMTYP	Genomic Symbol Type	Variable Qualifier	Perm	GF only
21	GF	GFGENLOC	Genetic Location	Variable Qualifier	Perm	GF only
22	GF	GFGENSR	Genetic Sub-Region	Variable Qualifier	Perm	GF only
23	GF	GFSEQID	Sequence Identifier \n	Variable Qualifier	Perm	GF only
24	GF	GFPVRID	Published Variant Identifier	Variable Qualifier	Perm	GF only
25	GF	GFCOPYID	Copy Identifier	Variable Qualifier	Perm	GF only
26	IS	ISMSCBCE	Molecule Secretet by Cells	Variable Qualifier	Perm	IS only
27	RELSPEC	REFID	Specimen ID	Identifier	Req
28	RELSPEC	SPEC	Specimen Type	Variable Qualifier	Perm
29	RELSPEC	PARENT	Specimen Parent	Identifier	Exp
30	RELSPEC	LEVEL	Specimen Level	Variable Qualifier	Req

> 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
--CHDY	Day of Obs Rel to Challenge Agent	Num		Timing	All Classes		Introduced in SDTM v1.8
--CHSTDY	Start Day of Obs Rel to Challenge Agent	Num		Timing	All Classes	Not in Findings class domains	Introduced in SDTM v1.8
--CHENDY	End Day of Obs Rel to Challenge Agent	Num		Timing	All Classes		Introduced in SDTM v1.8
--FTDOSD	Factor for Toxic/Physiologic Dose Descr	Num		Variable Qualifier	Interventions		Introduced in SDTM v1.8
--TDOSD	Toxic/Physiologic Dose Descr	Char		Record Qualifier	Interventions		Introduced in SDTM v1.8
--XDY	Day of Obs Relative to Exposure	Num		Timing	All Classes		Introduced in SDTM v1.8
--XSTDY	Start Day of Obs Relative to Exposure	Num		Timing	All Classes	Not in Findings class domains	Introduced in SDTM v1.8
--XENDY	End Day of Obs Relative to Exposure	Num		Timing	All Classes		Introduced in SDTM v1.8
--RSTIND	Restraint Indicator	Char		Record Qualifier	Interventions, Findings	Not in human clinical trials	Introduced in SDTM v1.8
--RSTMOD	Restraint Mode	Char		Record Qualifier	Interventions, Findings	Not in human clinical trials	Introduced in SDTM v1.8

> 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
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

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."
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."
3	MS	MSENDTC	End Date/Time of Observation	Num		Timing	Perm
4	MS	MSENDY	Study Day of End of Observation	Num		Timing	Perm
5	MS	MSENRF	End Relative to Reference Period	Char	(STENRF)	Timing	Perm
6	MS	MSENRTPT	End Relative to Reference Time Point	Char	(STENRF)	Timing	Perm
7	MS	MSENTPT	End Reference Time Point	Char		Timing	Perm
8	MS	MSMODIFY	Modified Reported Name	Char		Synonym Qualifier	Perm
9	MS	MSSPCUFL	Specimen Usability for the Test	Char	(NY)	Record Qualifier	Perm
10	MS	MSSTRF	Start Relative to Reference Period	Char	(STENRF)	Timing	Perm
11	MS	MSSTRTPT	Start Relative to Reference Time Point	Char	(STENRF)	Timing	Perm
12	MS	MSSTTPT	Start Reference Time Point	Char		Timing	Perm
13	QS	QSEVAL	Evaluator	Char	(EVAL)	Record Qualifier	Perm	Not in QS, FT, and clinical classifications use case of RS
14	UR	URSPCUFL	Specimen Usability for the Test	Char	(NY)	Record Qualifier	Perm
15	UR	URSPEC	Specimen Material Type	Char	(SPECTYPE)	Record Qualifier	Perm

> 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

> 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

> 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

> 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

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

> Variable Core values changed 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

> 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

> 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

> 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)

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

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