SDTM. Ejection Fraction

Does this need to be LVEDV? It is currently LVDV.

The CVTESTCD have "E", should the CVTEST have "End" in the term?

Ejection Fraction - Liters/minutes or percentage?

This example dataset shows the findings associated with a Cardiac Magnetic Resonance Imaging procedure related to ejection fraction. CVDTC is the date of the CMR procedure, CVDY is the study. For the purposes of this example, the participant was enrolled in the study on 20-May-2021 and the study visits were every twp months.The CVLNKID variable is used to identify a record to show a relationship between records in separate domains.

Rows 1-8:	Show the baseline CMR ejection fraction measurements for participant 101 at Screening.
Rows 9-16:	Show the CMR ejection fraction measurements for participant 101 at VISIT 6.

cv.xpt

Row	STUDYID	DOMAIN	USUBJID	CVSEQ	CVLNKID	CVTESTCD	CVTEST	CVORRES	CVORRESU	CVSTRESC	CVSTRESN	CVSTRESU	CVMETHOD	VISITNUM	VISIT	CVDTC	CVDY
1	DMD-EF	CV	101	1		RVESV	Right Ventricle Systolic Volume	23.5	mL	23.5	23.5	mL	CARDIAC MAGNETIC RESONANCE IMAGING	1	SCREENING	2022-05-16
2	DMD-EF	CV	101	2		RVEDV	Right Ventricle End Diastolic Volume	89.7	mL	89.7	89.7	mL	CARDIAC MAGNETIC RESONANCE IMAGING	1	SCREENING	2022-05-16
3	DMD-EF	CV	101	3	2	RVEF_C	Right Ventricular Ejection Fraction, Calculated	73.8	%	73.8	73.8	%	CARDIAC MAGNETIC RESONANCE IMAGING	1	SCREENING	2022-05-16
4	DMD-EF	CV	101	4	2	RVCO	RV Cardiac Output	5.6	L/min	5.6	5.6	L/min	CARDIAC MAGNETIC RESONANCE IMAGING	1	SCREENING	2022-05-16
5	DMD-EF	CV	101	5		LVESV	Left Ventricle Systolic Volume	31.7	mL	31.7	31.7	mL	CARDIAC MAGNETIC RESONANCE IMAGING	1	SCREENING	2022-05-16
6	DMD-EF	CV	101	6		LVEDV	Left Ventricle End Diastolic Volume	94.8	mL	94.8	94.8	mL	CARDIAC MAGNETIC RESONANCE IMAGING	1	SCREENING	2022-05-16
7	DMD-EF	CV	101	7	2	LVEF_C	Left Ventricular Ejection Fraction, Calculated	66.5	%	66.5	66.5	%	CARDIAC MAGNETIC RESONANCE IMAGING	1	SCREENING	2022-05-16
8	DMD-EF	CV	101	8	2	LVCO	LV Cardiac Output	5.4	L/min	5.4	5.4	L/min	CARDIAC MAGNETIC RESONANCE IMAGING	1	SCREENING	2022-05-16
9	DMD-EF	CV	101	9		RVSV	Right Ventricle Systolic Volume	35.9	mL	35.9	35.9	mL	CARDIAC MAGNETIC RESONANCE IMAGING	6	VISIT 6	2023-06-01	376
10	DMD-EF	CV	101	10		RVEDV	Right Ventricle End Diastolic Volume	92.8	mL	92.8	92.8	mL	CARDIAC MAGNETIC RESONANCE IMAGING	6	VISIT 6	2023-06-01	376
11	DMD-EF	CV	101	11	2	RVEF_C	Right Ventricular Ejection Fraction, Calculated	61.3	%	61.3	61.3	%	CARDIAC MAGNETIC RESONANCE IMAGING	6	VISIT 6	2023-06-01	376
12	DMD-EF	CV	101	12	2	RVCO	RV Cardiac Output	4.0	L/min	4.0	4.0	L/min	CARDIAC MAGNETIC RESONANCE IMAGING	6	VISIT 6	2023-06-01	376
13	DMD-EF	CV	101	13		LVESV	Left Ventricle Systolic Volume	37.4	mL	37.4	37.4	mL	CARDIAC MAGNETIC RESONANCE IMAGING	6	VISIT 6	2023-06-01	376
14	DMD-EF	CV	101	14		LVEDV	Left Ventricle Diastolic Volume	93.8	mL	93.8	93.8	mL	CARDIAC MAGNETIC RESONANCE IMAGING	6	VISIT 6	2023-06-01	376
15	DMD-EF	CV	101	15	2	LVEF_C	Left Ventricular Ejection Fraction, Calculated	60	%	60	60	%	CARDIAC MAGNETIC RESONANCE IMAGING	6	VISIT 6	2023-06-01	376
16	DMD-EF	CV	101	16	2	LVCO	LV Cardiac Output	4.0	L/min	4.0	4.0	L/min	CARDIAC MAGNETIC RESONANCE IMAGING	6	VISIT 6	2023-06-01	376

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Dataset Wrapper Debug Message

Please add a row column to your dataset.

Row 1:	Shows the results for the N-Terminal ProB-type Natriuretic Peptide test for participant 101 at Screening.
Row 2:	Shows the results for the N-Terminal ProB-type Natriuretic Peptide test at Visit 6.

lb.xpt

Row	STUDYID	DOMAIN	USUBJID	LBSEQ	LBLNKID	LBTESTCD	LBTEST	LBCAT	LBORRES	LBORRESU	LBORNRLO	LBORNRHI	LBSTRESC	LBSTRESN	LBSTRESU	LBSTNRLO	LBSTRNHI	LBNRIND	LBLOINC	LBSPEC	VISITNUM	VISIT	LBDTC	LBDY
1	DMD-EF	LB	101	1	2	BNPPRONT	N-Terminal ProB-type Natriuretic Peptide	CHEMISTRY	40	pg/mL	0	100	40	40	IU/L	100	40	NORMAL	71425-3	BLOOD	1	SCREENING	2022-05-16
2	DMD-EF	LB	101	2	2	BNPPRONT	N-Terminal ProB-type Natriuretic Peptide	CHEMISTRY	900	pg/mL	0	100	900	900	IU/L	100	900	HIGH	71425-3	BLOOD	6	VISIT 6	2023-06-01	376

Dataset Debug Messages

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Dataset Wrapper Debug Message

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The relationship between CV and LB is represented in the Related Records dataset (RELREC) . For more information on relating records, see the SDTMIG v3.4, Section 8.2.

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relrec.xpt

Row	STUDYID	RDOMAIN	USUBJID	IDVAR	IDVARVAL	RELTYPE	RELID
1	DMD-EF	CV		CVLNKID		MANY	2
2	DMD-EF	LB		LBLNKID		ONE	2

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