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The  Electrocardiogram (EG) domain is based on the Findings General Observation class. The EG domain is used to represent 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. 

OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
1Was the ECG performed?ECG PerformedIndicate whether or not an ECG or specific ECG test was done.TextEGSTATEGSTAT
(NY)N;Y
2What was the method used for the ECG?MethodRecord the method used for the ECG.TextEGMETHODEGMETHOD
(EGMETHOD)12 LEAD STANDARD;HOLTER CONTINUOUS ECG RECORDING
3What was the position of the subject during the ECG measurement?PositionRecord the position of the subject during the ECG.TextEGPOSEGPOS
(POSITION)SITTING;STANDING;SUPINE;SEMI-RECUMBENT;SEMI-FOWLERS
4What was date of the ECG?ECG DateRecord the date ECG was done using this format. DateEGDTCEGDTC



5What was the Mean Heart Rate?ECG Mean Heart RateRecord the test result.IntegerEGHRMN_EGORRESEGORRESEGORRES where EGTESTCD ="EGHRMN"


6What was the unit of the Mean Heart Rate?UnitRecord or select the original unit in which these data were collected, if not pre-printed on CRF.TextEGHRMN_EGORRESUEGORRESUEGORRESU where EGTESTCD = "EGHRMN"(Unit)beats/min
7What was the Aggregate PR Interval?PR Interval, AggregateRecord the test result.IntegerPRAG_EGORRESEGORRESEGORRES where EGTESTCD = "PRAG"


8What was the unit of the Aggregate PR Interval?UnitRecord or select the original unit in which these data were collected, if not pre-printed on CRF.TextPRAG_EGORRESUEGORRESUEGORRESU where EGTESTCD = "PRAG"(Unit)msecs
9What was the Aggregate QRS Duration?QRS Duration, AggregateRecord the test result.IntegerQRSAG_EGORRESEGORRES EGORRES where EGTESTCD = "QRSAG"


10What was the unit of the Aggregate QRS Duration?UnitRecord or select the original unit in which these data were collected, if not pre-printed on CRF.TextQRSAG_EGORRESUEGORRESU EGORRESU where EGTESTCD = "QRSAG"(Unit)msecs
11What was the Aggregate QT Interval?QT Interval, AggregateRecord the test result.IntegerQTAG_EGORRESEGORRES EGORRES where EGTESTCD = "QTAG"


12What was the unit of the Aggregate QT Interval result?UnitRecord or select the original unit in which these data were collected, if not pre-printed on CRF.TextQTAG_EGORRESUEGORRESU EGORRESU where EGTESTCD = "QTAG"(Unit)msecs
13What was the Aggregate QTca Interval?QTca Interval, AggregateRecord the test result. IntegerQTCAAG_EGORRESEGORRES EGORRES where EGTESTCD = "QTCA"


14What was the unit of the Aggregate QTca Interval?UnitRecord or select the original unit in which these data were collected, if not pre-printed on CRF.TextQTCAAG_EGORRESUEGORRESU EGORRESU where EGTESTCD = "QTCA"(Unit)msecs
15What was the overall interpretation of the ECG?InterpretationRecord the the test result.TextINTP_EGORRESEGORRES EGORRES where EGTESTCD = "INTP"(NORMABNM)NORMAL; ABNORMAL
16Was the ECG clinically significant?Clinically SignificantRecord whether ECG results were clinically significant.TextEGCLSIGEGCLSIG
 (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

eg.xpt

RowSTUDYIDDOMAINUSUBJIDEGSEQEGREFIDEGTESTCDEGTESTEGCATEGPOSEGORRESEGORRESUEGSTRESCEGSTRESNEGSTRESUEGNAMEGMETHODEGDRVFLEGCLSIGVISITNUMVISITEGDTCEGDY
1XYZEGXYZ-US-701-0021334PT89EGHRMNECG Mean Heart RateMEASUREMENTSUPINE62beats/min6262beats/minTest Lab12 LEAD STANDARD

1SCREENING2003-04-15T11:58-36
2XYZEGXYZ-US-701-0022334PT89PRAGPR Interval, AggregateINTERVALSUPINE0.15sec150150msecTest Lab12 LEAD STANDARD

1SCREENING2003-04-15T11:58-36
3XYZEGXYZ-US-701-0023334PT89QRSAGQRS Duration, AggregateINTERVALSUPINE0.103sec103103msecTest Lab12 LEAD STANDARD

1SCREENING2003-04-15T11:58-36
4XYZEGXYZ-US-701-0024334PT89QTAGQT Interval, AggregateINTERVALSUPINE0.406sec406406msecTest Lab12 LEAD STANDARD

1SCREENING2003-04-15T11:58-36
5XYZEGXYZ-US-701-0025334PT89QTCAQTcA Interval, AggregateINTERVALSUPINE

469469msecTest Lab12 LEAD STANDARDY
1SCREENING2003-04-15T11:58-36
6XYZEGXYZ-US-701-00212334PT89INTPInterpretation
SUPINEABNORMAL
ABNORMAL




Y1SCREENING2003-04-15T11:58-36
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

Example

This example shows a SDTM dataset that represents basic electrocardiogram data. 
Row 1: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 2:Shows an ECG that was not performed and the reason it was not performed.

eg.xpt

eg.xpt

RowSTUDYIDDOMAINUSUBJIDEGSEQEGTESTCDEGTESTEGORRESEGSTRESCEGSTATEGREASNDEGCLSIGVISITNUMVISITEGDTCEGDY
1TBEG1EGS-701-0021INTPInterpretationABNORMALABNORMAL

Y1SCREENING2003-04-15-36
2TBEG1EGS-701-0031EGALLECG Test Resuts

NOT DONESUBJECT REFUSED
1SCREENING

$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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