Japan CCCIDM SMIS: Laboratory Data

Illustrates Domains

Illustrates Variables

ABLFL

Illustrates Data Structures

ADAM OTHER

Content

Many qualifier variables for lab tests are expected per rules of the SDTM LB domain, and are therefore shown in the example below. Some of these may not be available in a retrospective query of real world data. Other permissible variables such as fasting status (LBFAST) are also shown. Any permissible variable can be added (or excluded) from the dataset as necessary. Expected variables are not required, but excluding them would result in a warning if the dataset is validated with validation software. Refer to the SDTMIG v3.4, section 6.3.5.6, Laboratory Test Results (LB) for a full description of these variables.

The following examples include for laboratory measurements and results including point of care glucose testing at home.

SMIS Item Numbers illustrated include: 5 - LDL-cholesterol, 6 - HDL-cholesterol, 8 - Serum creatinine, 9 - Urine protein, 10 - Blood glucose, 12 - HbA1c (NGSP), 13 - AST, 16 - Serum potassium, 18 - Triglyceride, 22 - Serum albumin, 23 - Hematuria (Occult blood in urine), 24 - Total cholesterol, 25 - Urine albumin/creatinine, 26 - AST, 28 - Urine glucose, 29 - y-GTP (GGT), 32 - Uric acid (Urate), 36 - Urine protein/creatinine, 37 - Urine protein/Day, 38 - Serum total protein, 39 - BUN, 40 - Hemoglobin, 41 - Cystatin C, 42 - Self-monitoring blood glucose

The row descriptions below only reference rows in the example that are notable for their use of variables or for their use of controlled terminology which differs from the SMIS Item Sets.

Example 3a

Row 6:	Shows BUN as LBTEST= "Urea Nitrogen", with a specimen type (LBSPEC) of "SERUM".
Rows 8, 16:	Show blood glucose and urine glucose. Note that the specimen type (LBSPEC) in Row 8 is "SERUM", not "BLOOD", as this is standard laboratory practice.
Row 14:	Shows urine protein/day. The variable LBPDUR (planned duration) is used to show that the collection lasted 24 hours, using ISO 8601 duration format "PT24H".
Rows 17-18:	Show two tests for hematuria. The first test (Row 17) is for Macroscopic Blood. The result was POSITIVE (but PRESENT/ABSENT values could have also been used). The investigator categorized this result as MACROHEMATURIA in LBRESCAT (Result Category). The second test was for Occult Blood. The result was 3+, which was standardized to "MODERATE" in standard result variable LBSTRESC. The investigator categorized this result as MICROHEMATURIA in LBRESCAT. Both tests use a specimen type of "URINE" as indicated in LBSPEC (specimen type).

lb.xpt

Row	STUDYID	DOMAIN	USUBJID	LBSEQ	LBTESTCD	LBTEST	LBCAT	LBORRES	LBORRESU	LBORNRLO	LBORNRHI	LBSTRESC	LBSTRESN	LBSTRESU	LBSTNRLO	LBSTNRHI	LBSTNRC	LBNRIND	LBRESCAT	LBLOINC	LBSPEC	LBMETHOD	LBFAST	VISITNUM	LBDTC	LBPDUR
1	ABCDE	LB	ABCDE-001	1	LDL	LDL Cholesterol	CHEMISTRY	60	mg/dL	0	109	60	60	mg/dL	0	109				2085-9	SERUM		Y	1	2020-06-19
2	ABCDE	LB	ABCDE-001	2	HDL	HDL Cholesterol	CHEMISTRY	50	mg/dL	45		50	50	mg/dL	45					18262-6	SERUM		Y	1	2020-06-19
3	ABCDE	LB	ABCDE-001	3	CHOL	Cholesterol	CHEMISTRY	229	mg/dL	0	200	229	229	mg/dL	0	200				2093-3	SERUM		Y	1	2020-06-19
4	ABCDE	LB	ABCDE-001	4	TRIG	Triglycerides	CHEMISTRY	160	mg/dL	0	<150	160	160	mg/dL	0	149		HIGH		2571-8	SERUM		Y	1	2020-06-19
5	ABCDE	LB	ABCDE-001	5	CREAT	Creatinine	CHEMISTRY	0.80	mg/dL	0.50	1.03	0.80	0.80	mg/dL	0.50	1.03				2160-0	SERUM		Y	1	2020-06-19
6	ABCDE	LB	ABCDE-001	6	UREAN	Urea Nitrogen	CHEMISTRY	14	mg/dL	7	20	14	14	mg/dL	7	20				3094-0	SERUM		Y	1	2020-06-19
7	ABCDE	LB	ABCDE-001	7	K	Potassium	CHEMISTRY	3.7	mmol/L	3.4	4.8	3.7	3.7	mEq/L	3.5	5.2				2823-3	SERUM		Y	1	2020-06-19
8	ABCDE	LB	ABCDE-001	8	GLUC	Glucose	CHEMISTRY	250	mg/dL	70	99	250	250	mg/dL	70	99		HIGH		2339-0	BLOOD		Y	1	2020-06-19
9	ABCDE	LB	ABCDE-001	9	ALB	Albumin	CHEMISTRY	3.9	g/dL	3.5	5.5	3.9	3.9	g/dL	3.5	5.5				1751-7	SERUM		Y	1	2020-06-19
10	ABCDE	LB	ABCDE-001	10	ALT	Alanine Aminotransferase	CHEMISTRY	30	U/L	10	40	30	30	U/L	10	40				1742-6	SERUM		Y	1	2020-06-19
11	ABCDE	LB	ABCDE-001	11	AST	Aspartate Aminotransferase	CHEMISTRY	20	U/L	12	38	20	20	U/L	12	38				1920-8	SERUM		Y	1	2020-06-19
12	ABCDE	LB	ABCDE-001	12	PROT	Protein	CHEMISTRY	7.1	g/dL	6.0	7.8	7.1	7.1	g/dL	6.0	7.8				2885-2	SERUM		Y	1	2020-06-19
13	ABCDE	LB	ABCDE-001	13	HCG	Hemoglobin	HEMATOLOGY	14.2	g/dL	13.8	17.2	14.2	14.2	g/dL	13.8	17.2				718-7	BLOOD		Y	1	2020-06-19
14	ABCDE	LB	ABCDE-001	14	PROT	Protein	CHEMISTRY	200	mg	30	150	0.2	0.2	g	0.03	0.15				2889-4	URINE		N	1	2020-06-19	PT24H
15	ABCDE	LB	ABCDE-001	15	PROT	Protein	URINALYSIS	3+		0	4+	MODERATE					NEGATIVE to TRACE	ABNORMAL		5804-0	URINE	TEST STRIP	Y	1	2020-06-19
16	ABCDE	LB	ABCDE-001	16	GLUC	Glucose	URINALYSIS	1+		0	4+	TRACE					NEGATIVE	ABNORMAL			URINE	TEST STRIP	Y	1	2020-06-19
17	ABCDE	LB	ABCDE-001	17	MACROBLD	Macroscopic Blood	URINALYSIS	POSITIVE		NEGATIVE	NEGATIVE	POSITIVE		NEGATIVE	NEGATIVE		NEGATIVE	ABNORMAL	MACROHEMATURIA	53963-5	URINE		Y	1	2020-06-19
18	ABCDE	LB	ABCDE-001	18	OCCBLD	Occult Blood	URINALYSIS	3+		-	4+	MODERATE					NEGATIVE to TRACE	ABNORMAL	MICROHEMATURIA	105906-2	URINE		Y	1	2020-06-19
19	ABCDE	LB	ABCDE-001	19	ALBCREAT	Albumin/Creatinine	CHEMISTRY	15	mg/g	0	30	15	15	g/kg	0	30				32294-1	URINE		Y	1	2020-06-19
20	ABCDE	LB	ABCDE-001	20	HBA1C	Hemoglobin A1C	CHEMISTRY	8.0	%	0	<5.7	64	64	mmol/mol	0	39				41995-2	SERUM		Y	1	2020-06-19
21	ABCDE	LB	ABCDE-001	21	GGT	Gamma Glutamyl Transferase	CHEMISTRY	11	U/L	6	50	11	11	U/L	6	50				2324-2	SERUM		Y	1	2020-06-19
22	ABCDE	LB	ABCDE-001	22	URATE	Urate	CHEMISTRY	4.1	mg/dL	2.5	7.0	4.1	4.1	mg/dL	2.5	7.0				3084-1	SERUM		Y	1	2020-06-19
23	ABCDE	LB	ABCDE-001	23	PROTCRT	Protein/Creatinine	CHEMISTRY	0.2	g/g	0	0.2	0.2	0.2	g/g	0	0.2				2890-2	URINE		Y	1	2020-06-19
24	ABCDE	LB	ABCDE-001	24	CYSTATC	Cystatin C	CHEMISTRY	3.2	mg/L	0.67	6.15	3.2	3.2	mg/L	0.67	6.15				33863-2	SERUM		Y	1	2020-06-19

Example 3b

The following example shows how to represent self-monitoring of blood glucose performed at home by the participant using a glucometer point of care self-test at different times related to meals. The non-standard variable LBSETTNG indicates the setting as being either at home or in clinic.

Rows 1, 8:	LBFAST=Y showing that the SMBG measurements (LBTPTNUM=1 and 8) were performed when the subject was fasting according to the protocol definition.
Rows 2-8:	LBORRES show glucose measurements taken at specified time points. Post-Midday Meal time point was not done.
Row 9:	LBDTC, LBFAST and LBTPT show that in a 9-point SMBG profile the 9th measurement is taken fasting (pre-morning meal) according to the protocol definition the next day in the morning and thus is the corresponding record to Row 1 representing the first measurement of the first day.
Row 10:	Shows the blood glucose test check done in the clinic setting. The LBTPT was null because the observation represents a one-time fasting glucose and not glucose timing around meals.

lb.xpt

Row	STUDYID	DOMAIN	USUBJID	LBSEQ	LBTESTCD	LBTEST	LBORRES	LBORRESU	LBORNRLO	LBORNRHI	LBSTRESC	LBSTRESN	LBSTRESU	LBSTAT	LBSPEC	LBFAST	VISITNUM	VISIT	LBDTC	LBTPT	LBTPTNUM	LBSETTNG
1	ABCDE	LB	ABCDE-001	1	GLUC	Glucose	155	mg/dL	65	99	155	155	mg/dL		BLOOD	Y	2	WEEK 2	2020-06-10T06:00	PRE-MORNING MEAL	1	Home
2	ABCDE	LB	ABCDE-001	2	GLUC	Glucose	220	mg/dL	65	139	220	220	mg/dL		BLOOD	N	2	WEEK 2	2020-06-10T08:08	POST-MORNING MEAL	2	Home
3	ABCDE	LB	ABCDE-001	3	GLUC	Glucose	146	mg/dL	65	120	146	146	mg/dL		BLOOD	N	2	WEEK 2	2020-06-10T12:00	PRE-MIDDAY MEAL	3	Home
4	ABCDE	LB	ABCDE-001	4	GLUC	Glucose								NOT DONE	BLOOD		2	WEEK 2	2020-06-10	POST-MIDDAY MEAL	4	Home
5	ABCDE	LB	ABCDE-001	5	GLUC	Glucose	140	mg/dL	65	120	140	140	mg/dL		BLOOD	N	2	WEEK 2	2020-06-10T18:00	PRE-EVENING MEAL	5	Home
6	ABCDE	LB	ABCDE-001	6	GLUC	Glucose	214	mg/dL	65	139	214	214	mg/dL		BLOOD	N	2	WEEK 2	2020-06-10T19:00	POST-EVENING MEAL	6	Home
7	ABCDE	LB	ABCDE-001	7	GLUC	Glucose	148	mg/dL	65	139	148	148	mg/dL		BLOOD	N	2	WEEK 2	2020-06-10T22:00	BEDTIME	7	Home
8	ABCDE	LB	ABCDE-001	8	GLUC	Glucose	137	mg/dL	65	99	137	137	mg/dL		BLOOD	Y	2	WEEK 2	2020-06-11T03:20	OVERNIGHT	8	Home
9	ABCDE	LB	ABCDE-001	9	GLUC	Glucose	133	mg/dL	65	99	133	133	mg/dL		BLOOD	Y	2	WEEK 2	2020-06-11T06:00	NEXT DAY PRE-MORNING MEAL	9	Home
10	ABCDE	LB	ABCDE-002	1	GLUC	Glucose	90	mg/dL	65	99	90	90	mg/dL		BLOOD	Y	2	WEEK 2	2020-06-20T09:00		1	Clinic

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LB NSV Metadata

Variable	Label	Type	Codelist	Role	Origin
LBSETTNG	Finding Setting	text		Non-standard Record Qualifier	CRF