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title	lb.xpt
Name	is

Dataset2

Row	STUDYID	DOMAIN	USUBJID	ISSEQ	ISGRPID	ISTESTCD	ISTEST	ISBDAGNT	ISTSTOPO	ISCAT	ISORRES	ISORRESU	ISSTRESC	ISSTRESN	ISSTRESU	ISMETHOD	VISITNUM	VISIT	MBDTC
1	ABC	IS	ABC-001	1	1		Anti-microbial IgM Antibody	SARS-CoV-2	SCREEN	MICROBIOLOGY	YES		YES	YES		EIA	1	SCREEN	2018-06-01
2	ABC	IS	ABC-001	3	1		Anti-microbial IgM Antibody	SARS-CoV-2	QUANTIFY	MICROBIOLOGY	350	Titer	350	350	Titer	EIA	1	SCREEN	2018-06-01

lab The LB drug tox screen example of TSTPOP.

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Name	lb

Rowcaps

Row 1:	Shows Cannabinoids are screened.
Row 2:	Shows the previously detected Cannabinoids are further confirmed in the subject.
Row 3:	Shows the quantification of the Cannabinoids.

Dataset2

Row	STUDYID	DOMAIN	USUBJID	LBGRPID	LBSEQ	LBTESTCD	LBTEST	LBTSTOPO	LBCAT	LBORRES	LBORRESU	LBSTRESC	LBSTRESN	LBSTRESU	LBSPEC	LBMETHOD	LBLOINC	LBDTC	VISITNUM	VISIT
1	ABC	LB	ABC-001-001	1	1	CANNAB	Cannabinoids	SCREEN	DRUG TOXICITY	POSITIVE		POSITIVE	POSITIVE		URINE	KINETIC MICROPARTICLE IMMUNOASSAY	19287-2	2013-02-16	1	Week 1
2	ABC	LB	ABC-001-001	1	2	CANNAB	Cannabinoids	CONFIRM	DRUG TOXICITY	250	ug/L	POSITIVE			URINE	MASS SPECTROMETRY	19289-8	2013-02-16	1	Week 1
3	ABC	LB	ABC-001-001	1	3	CANNAB	Cannabinoids	QUANTIFY	DRUG TOXICITY	271	ug/L	271	271	ug/L	URINE	GC/MS	19291-4	2013-02-16	1	Week 1

The IS ADA example using TSTPOP.

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title	lb.xpt
Name	is

Rowcaps

Row 1:	Shows the screening of the presence of ADA to DRUG AZ-007.
Row 2:	Shows the confirmation of the previously detected ADA to DRUG AZ-007.
Row 3:	Shows the quantification of the said ADA from the screen and confirmatory steps.

Dataset2

Row	STUDYID	DOMAIN	USUBJID	ISSEQ	ISREFID	ISGRPID	ISTESTCD	ISTEST	ISBDAGNT	ISTSTOPO	ISCAT	ISSCAT	ISORRES	ISORRESU	ISSTRESC	ISSTRESN	ISSTRESU	ISSPEC	ISMETHOD	VISITNUM	VISIT	ISDTC
1	ABC	IS	ABC-002	1	V555	1	ADA_BAB	Binding Antidrug Antibody	DRUG AZ-007	SCREEN	ANTIDRUG ANTIBODIES	HUMORAL IMMUNITY	POSITIVE		POSITIVE			SERUM	ELECTROCHEMILUMINESCENCE IMMUNOASSAY	1	VISIT 1	2017-07-27
2	ABC	IS	ABC-002	2	V555	1	ADA_BAB	Binding Antidrug Antibody	DRUG AZ-007	CONFIRM	ANTIDRUG ANTIBODIES	HUMORAL IMMUNITY	POSITIVE		POSITIVE			SERUM	ELECTROCHEMILUMINESCENCE IMMUNOASSAY	1	VISIT 1	2017-07-27
3	ABC	IS	ABC-002	3	V555	1	ADA_BAB	Binding Antidrug Antibody	DRUG AZ-007	QUANTIFY	ANTIDRUG ANTIBODIES	HUMORAL IMMUNITY	50	titer	50	50	titer	SERUM	ELECTROCHEMILUMINESCENCE IMMUNOASSAY	1	VISIT 1	2017-07-27

Nsvmeta

Domain	IS

Variable	Label	Type	Role	Origin
ISTSTOPO	Test Operational Objective	text	Non-Standard Record Qualifier	CRF

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