ECG Example 1

Indicate whether or not an ECG or specific ECG test was done.	Was the ECG performed? EGPERF EGSTAT	Yes No <NY codelist>
Record the method used for the ECG.	What was the method used for the ECG? EGMETHOD	6 Lead Standard 8 Lead Standard 10 Lead Standard 12 Lead Standard <EGMETHOD codelist>
Record the position of the subject during the ECG.	What was the position of the subject during the ECG measurement? EGPOS	Supine Sitting <POSITION codelist>
Record the date ECG was done using this format (DD-MON-YYYY).	ECG Date EGDAT EGDTC	_ _ / _ _ _ / _ _ _ _
Record the time point labels for when the ECG test should be taken, if not pre-printed on the CRF.	What was the planned time point of the ECG measurement? EGTPT	_________________
Record the time the ECG was done (as complete as possible).	ECG Time EGTIM EGDTC	_ _ : _ _ : _ _
Record the test result.	What was the Aggregate PR Interval? PRAG_EGORRES EGORRES where EGTESTCD = "PRAG"	_________________
	Unit PRAG_EGORRESU EGORRESU where EGTESTCD = "PRAG" Pre-populated	msecs <Unit codelist>
Record the test result.	What was the Aggregate QRS Duration? QRSAG_EGORRES EGORRES where EGTESTCD = "QRSAG"	_________________
	Unit QRSAG_EGORRESU EGORRESU where EGTESTCD = "QRSAG" Pre-populated	msecs <Unit codelist>
Record the test result.	What was the Aggregate QT Interval? QTAG_EGORRES EGORRES where EGTESTCD = "QTAG"	_________________
	Unit QTAG_EGORRESU EGORRESU where EGTESTCD = "QTAG" Pre-populated	msecs <Unit codelist>
Record the test result.	What was the Aggregate QTca Interval? QTCAAG_EGORRES EGORRES where EGTESTCD = "QTCAAG"	_________________
	Unit QTCAAG_EGORRESU EGORRESU where EGTESTCD = "QTCAAG" Pre-populated	msecs <Unit codelist>
Record the the test result.	What was the overall interpretation of the ECG? INTP_EGORRES EGORRES where EGTESTCD = "INTP"	Normal Abnormal <NORMABNM codelist>
Record whether ECG results were clinically significant.	Was the ECG clinically significant? EGCLSIG SUPPEG.QVAL where SUPPEG.QNAM = "EGCLSIG" and SUPPEG.QLABEL= "Clinically Significant" and EGTESTCD= "INTP"	Yes No <NY codelist>

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
PRAG_EGORRES	7	What was the Aggregate PR Interval?	PR Interval, Aggregate	Record the test result.	Text	EGORRES	EGORRES where EGTESTCD = "PRAG"
PRAG_EGORRESU	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	EGORRES	EGORRESU where EGTESTCD = "PRAG"	(Unit)		msecs
QRSAG_EGORRES	9	What was the Aggregate QRS Duration?	QRS Duration, Aggregate	Record the test result.	Text	EGORRES	EGORRES where EGTESTCD = "QRSAG"
QRSAG_EGORRESU	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	EGORRES	EGORRESU where EGTESTCD = "QRSAG"	(Unit)		msecs
QTAG_EGORRES	11	What was the Aggregate QT Interval?	QT Interval, Aggregate	Record the test result.	Text	EGORRES	EGORRES where EGTESTCD = "QTAG"
QTAG_EGORRESU	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	EGORRES	EGORRESU where EGTESTCD = "QTAG"	(Unit)		msecs
QTCAAG_EGORRES	13	What was the Aggregate QTca Interval?	QTca Interval, Aggregate	Record the test result.	Text	EGORRES	EGORRES where EGTESTCD = "QTCAAG"
QTCAAG_EGORRESU	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	EGORRES	EGORRESU where EGTESTCD = "QTCAAG"	(Unit)		msecs
INTP_EGORRES	15	What was the overall interpretation of the ECG?	Interpretation	Record the the test result.	Text	EGORRES	EGORRES where EGTESTCD = "INTP"	(NORMABNM)	Normal; Abnormal
EGCLSIG	16	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

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ECG Example 1