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This example shows a CRF that collects electrocardiogram data utilizing a local reader.

Xformpusher

CDASH Variable	Order	Question Text	Prompt	CRF Completion Instructions	Type	SDTMIG Target Variable	SDTM Target Mapping	Controlled Terminology Code List Name	Permissible Values	Pre-Populated Value
EGPERF	1	Was the ECG performed?	ECG Performed	Indicate whether or not an ECG or specific ECG test was done.	Text	EGSTAT		(NY)	Yes; No
EGMETHOD	2	What was the method used for the ECG?	Method	Record the method used for the ECG.	Text	EGMETHOD		(EGMETHOD)	6 Lead Standard; 8 Lead Standard; 10 Lead Standard; 12 Lead Standard
EGPOS	3	What was the position of the subject during the ECG measurement?	Position	Record the position of the subject during the ECG.	Text	EGPOS		(POSITION)	Supine; Sitting
EGDAT	4	What was date of the ECG?	ECG Date	Record the date ECG was done using this format (DD-MON-YYYY).	Date	EGDTC
EGTPT	5	What was the planned time point of the ECG measurement?	[Planned Time Point Name]	Record the time point labels for when the ECG test should be taken, if not pre-printed on the CRF.	Text	EGTPT
EGTIM	6	What was the time the ECG was collected?	ECG Time	Record the time the ECG was done (as complete as possible).	Time	EGDTC
EGHRMN_EGORRES	7	What was the Mean Heart Rate?	ECG Mean Heart Rate	Record the test result.	Text	EGORRES	EGORRES where EGTESTCD = "EGHRMN"			beats/min
EGHRMN_EGORRESU	8	What was the unit of the Mean Heart Rate?	Unit	Record or select the original unit in which these data were collected, if not pre-printed on CRF.	Text	EGORRES	EGORRESU where EGTESTCD = "EGHRMN"	(Unit)		msecs
PRAG_EGORRES	9	What was the Aggregate PR Interval?	PR Interval, Aggregate	Record the test result.	Text	EGORRES	EGORRES where EGTESTCD = "PRAG"
PRAG_EGORRESU	10	What was the unit of the Aggregate PR Interval?	Unit	Record or select the original unit in which these data were collected, if not pre-printed on CRF.	Text	EGORRES	EGORRESU where EGTESTCD = "PRAG"	(Unit)		msecs
QRSAG_EGORRES	11	What was the Aggregate QRS Duration?	QRS Duration, Aggregate	Record the test result.	Text	EGORRES	EGORRES where EGTESTCD = "QRSAG"
QRSAG_EGORRESU	12	What was the unit of the Aggregate QRS Duration?	Unit	Record or select the original unit in which these data were collected, if not pre-printed on CRF.	Text	EGORRES	EGORRESU where EGTESTCD = "QRSAG"	(Unit)		msecs
QTAG_EGORRES	13	What was the Aggregate QT Interval?	QT Interval, Aggregate	Record the test result.	Text	EGORRES	EGORRES where EGTESTCD = "QTAG"
QTAG_EGORRESU	14	What was the unit of the Aggregate QT Interval result?	Unit	Record or select the original unit in which these data were collected, if not pre-printed on CRF.	Text	EGORRES	EGORRESU where EGTESTCD = "QTAG"	(Unit)		msecs
QTCAAG_EGORRES	15	What was the Aggregate QTca Interval?	QTca Interval, Aggregate	Record the test result.	Text	EGORRES	EGORRES where EGTESTCD = "QTCA"
QTCAAG_EGORRESU	16	What was the unit of the Aggregate QTca Interval?	Unit	Record or select the original unit in which these data were collected, if not pre-printed on CRF.	Text	EGORRES	EGORRESU where EGTESTCD = "QTCA"	(Unit)		msecs
INTP_EGORRES	17	What was the overall interpretation of the ECG?	Interpretation	Record the the test result.	Text	EGORRES	EGORRES where EGTESTCD = "INTP"	(NORMABNM)	Normal; Abnormal
EGCLSIG	18	Was the ECG clinically significant?	Clinically Significant	Record whether ECG results were clinically significant.	Text	SUPPEG.QVAL	SUPPEG.QVAL where SUPPEG.QNAM = "EGCLSIG" and SUPPEG.QLABEL= "Clinically Significant" and EGTESTCD= "INTP"	(NY)	Yes;No

This is the SDTM data associated with the CRF above.

Dataset wrap

Name	eg

Rowcaps

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".

Dataset2

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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