SDTM Example.Electrocardiogram Overall Assessment

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

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	_ _ : _ _ : _ _
	ECG Mean Heart Rate EGHRMN_EGORRES EGORRES where EGTESTCD = "EGHRMN" Pre-populated	beats/min
	Unit EGHRMN_EGORRESU EGORRESU where EGTESTCD = "EGHRMN" Pre-populated	msecs <Unit codelist>
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 = "QTCA"	_________________
	Unit QTCAAG_EGORRESU EGORRESU where EGTESTCD = "QTCA" 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
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.

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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SDTM Example.Electrocardiogram Overall Assessment