SDTM Example.Electrocardiogram Overall Assessment

This is the SDTM data associated with the CRF above.

Row 1:	Shows a measurement of ventricular rate. This result was assessed as not clinically significant (EGCLSIG = "N").
Row 2:	Shows a measurement of PR interval. This result was assessed as clinically significant (EGCLSIG = "Y").
Rows 3-4:	These interval measurements were collected in seconds. However, in this submission, the standard unit for these tests was milliseconds, so the results have been converted in EGSTRESC and EGSTRESN.
Row 5:	Show "QTcB Interval, Aggregate". This result was derived by the sponsor, as indicated by the “Y” in the EGDRVFL column. Note that EGORRES is null for these derived records.
Row 6:	Shows the result of the TEST "Interpretation" (i.e., the interpretation of the ECG strip as a whole), which for this ECG was "ABNORMAL".

Row Captions Debug Message

Remember to keep number agreement between labels and captions.

eg.xpt

Row	STUDYID	DOMAIN	USUBJID	EGSEQ	EGREFID	EGTESTCD	EGTEST	EGCAT	EGPOS	EGORRES	EGORRESU	EGSTRESC	EGSTRESN	EGSTRESU	EGNAM	EGMETHOD	EGDRVFL	EGCLSIG	VISITNUM	VISIT	EGDTC	EGDY
1	XYZ	EG	XYZ-US-701-002	1	334PT89	EGHRMN	ECG Mean Heart Rate	MEASUREMENT	SUPINE	62	beats/min	62	62	beats/min	Test Lab	12 LEAD STANDARD		N	1	SCREENING	2003-04-15T11:58	-36
2	XYZ	EG	XYZ-US-701-002	2	334PT89	PRAG	PR Interval, Aggregate	INTERVAL	SUPINE	0.15	sec	150	150	msec	Test Lab	12 LEAD STANDARD		Y	1	SCREENING	2003-04-15T11:58	-36
3	XYZ	EG	XYZ-US-701-002	3	334PT89	QRSAG	QRS Duration, Aggregate	INTERVAL	SUPINE	0.103	sec	103	103	msec	Test Lab	12 LEAD STANDARD			1	SCREENING	2003-04-15T11:58	-36
4	XYZ	EG	XYZ-US-701-002	4	334PT89	QTAG	QT Interval, Aggregate	INTERVAL	SUPINE	0.406	sec	406	406	msec	Test Lab	12 LEAD STANDARD			1	SCREENING	2003-04-15T11:58	-36
5	XYZ	EG	XYZ-US-701-002	5	334PT89	QTCA	QTcA Interval, Aggregate	INTERVAL	SUPINE			469	469	msec	Test Lab	12 LEAD STANDARD	Y		1	SCREENING	2003-04-15T11:58	-36
6	XYZ	EG	XYZ-US-701-002	12	334PT89	INTP	Interpretation		SUPINE	ABNORMAL		ABNORMAL							1	SCREENING	2003-04-15T11:58	-36

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Dataset Wrapper Debug Message

Please add a row column to your dataset.

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