Electrocardiogram

The Electrocardiogram (EG) domain includes ECG data, including the position of the subject; method of evaluation; all cycle measurements; and all findings from the ECG, including an overall interpretation, if collected. This data may be collected at the local site, or at a central lab. Routine ECG date collected in clinical trials is often collected at the study site.

Example

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

Order	Question Text	Prompt	Case Report Form Completion Instructions	Type	Collection Variable	Tabulation Target	Mapping Instructions	Controlled Terminology CodeList Name	Permissible Values
1	Was the ECG performed?	ECG Performed	Indicate whether or not an ECG or specific ECG test was done.	Text	EGSTAT	EGSTAT		(NY)	N;Y
2	What was the method used for the ECG?	Method	Record the method used for the ECG.	Text	EGMETHOD	EGMETHOD		(EGMETHOD)	12 LEAD STANDARD;HOLTER CONTINUOUS ECG RECORDING
3	What was the position of the subject during the ECG measurement?	Position	Record the position of the subject during the ECG.	Text	EGPOS	EGPOS		(POSITION)	SITTING;STANDING;SUPINE;SEMI-RECUMBENT;SEMI-FOWLERS
4	What was date of the ECG?	ECG Date	Record the date ECG was done using this format.	Date	EGDTC	EGDTC
5	What was the Mean Heart Rate?	ECG Mean Heart Rate	Record the test result.	Integer	EGHRMN_EGORRES	EGORRES	EGORRES where EGTESTCD ="EGHRMN"
6	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	EGHRMN_EGORRESU	EGORRESU	EGORRESU where EGTESTCD = "EGHRMN"	(Unit)	beats/min
7	What was the Aggregate PR Interval?	PR Interval, Aggregate	Record the test result.	Integer	PRAG_EGORRES	EGORRES	EGORRES where EGTESTCD = "PRAG"
8	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	PRAG_EGORRESU	EGORRESU	EGORRESU where EGTESTCD = "PRAG"	(Unit)	msecs
9	What was the Aggregate QRS Duration?	QRS Duration, Aggregate	Record the test result.	Integer	QRSAG_EGORRES	EGORRES	EGORRES where EGTESTCD = "QRSAG"
10	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	QRSAG_EGORRESU	EGORRESU	EGORRESU where EGTESTCD = "QRSAG"	(Unit)	msecs
11	What was the Aggregate QT Interval?	QT Interval, Aggregate	Record the test result.	Integer	QTAG_EGORRES	EGORRES	EGORRES where EGTESTCD = "QTAG"
12	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	QTAG_EGORRESU	EGORRESU	EGORRESU where EGTESTCD = "QTAG"	(Unit)	msecs
13	What was the Aggregate QTca Interval?	QTca Interval, Aggregate	Record the test result.	Integer	QTCAAG_EGORRES	EGORRES	EGORRES where EGTESTCD = "QTCA"
14	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	QTCAAG_EGORRESU	EGORRESU	EGORRESU where EGTESTCD = "QTCA"	(Unit)	msecs
15	What was the overall interpretation of the ECG?	Interpretation	Record the the test result.	Text	INTP_EGORRES	EGORRES	EGORRES where EGTESTCD = "INTP"	(NORMABNM)	NORMAL; ABNORMAL
16	Was the ECG clinically significant?	Clinically Significant	Record whether ECG results were clinically significant.	Text	EGCLSIG	EGCLSIG		(NY)	N:Y:

This is the SDTM data associated with the CRF above.

Row 1:	Shows a measurement of ventricular rate.
Row 2:	Shows a measurement of PR interval.
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:	Shows "QTcB Interval, Aggregate". This result was derived by the applicant, 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". This result was assessed as clinically significant (EGCLSIG = "Y").

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			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			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						Y	1	SCREENING	2003-04-15T11:58	-36

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