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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
<NY codelist>
Record the method used for the ECG.What was the method used for the ECG?
EGMETHOD
<EGMETHOD codelist>
Record the position of the subject during the ECG.What was the position of the subject during the ECG measurement?
EGPOS
<POSITION codelist>
Record the date ECG was done using this format (DD-MON-YYYY).
EGDAT EGDTC
_ _ / _ _ _ / _ _ _ _
Record the time point labels for when the ECG test should be taken, if not pre-printed on the CRF.
EGTPT
_________________
Record the time the ECG was done (as complete as possible).
EGTIM EGDTC
_ _ : _ _ : _ _
EGHRMN_EGORRES EGORRES where EGTESTCD = "EGHRMN"
Pre-populated
beats/min
EGHRMN_EGORRESU EGORRESU where EGTESTCD = "EGHRMN"
Pre-populated
msecs
<Unit codelist>
Record the test result.
PRAG_EGORRES EGORRES where EGTESTCD = "PRAG"
_________________
PRAG_EGORRESU EGORRESU where EGTESTCD = "PRAG"
Pre-populated
msecs
<Unit codelist>
Record the test result.
QRSAG_EGORRES EGORRES where EGTESTCD = "QRSAG"
_________________
QRSAG_EGORRESU EGORRESU where EGTESTCD = "QRSAG"
Pre-populated
msecs
<Unit codelist>
Record the test result.
QTAG_EGORRES EGORRES where EGTESTCD = "QTAG"
_________________
QTAG_EGORRESU EGORRESU where EGTESTCD = "QTAG"
Pre-populated
msecs
<Unit codelist>
Record the test result.
QTCAAG_EGORRES EGORRES where EGTESTCD = "QTCA"
_________________
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"
<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"
<NY codelist>
CDASH VariableOrderQuestion TextPromptCRF Completion InstructionsTypeSDTMIG Target VariableSDTM Target MappingControlled Terminology Code List NamePermissible ValuesPre-Populated ValueQuery DisplayList StyleHidden
EGPERF1Was the ECG performed?ECG PerformedIndicate whether or not an ECG or specific ECG test was done.TextEGSTAT
(NY)Yes; No



EGMETHOD2What was the method used for the ECG?MethodRecord the method used for the ECG.TextEGMETHOD
(EGMETHOD)6 Lead Standard; 8 Lead Standard; 10 Lead Standard; 12 Lead Standard



EGPOS3What was the position of the subject during the ECG measurement?PositionRecord the position of the subject during the ECG.TextEGPOS
(POSITION)Supine; Sitting



EGDAT4What was date of the ECG?ECG DateRecord the date ECG was done using this format (DD-MON-YYYY).DateEGDTC






EGTPT5What 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.TextEGTPT






EGTIM6What was the time the ECG was collected?ECG TimeRecord the time the ECG was done (as complete as possible).TimeEGDTC






EGHRMN_EGORRES7What was the Mean Heart Rate?ECG Mean Heart RateRecord the test result.TextEGORRESEGORRES where EGTESTCD = "EGHRMN"

beats/min


EGHRMN_EGORRESU8What 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.TextEGORRESEGORRESU where EGTESTCD = "EGHRMN"(Unit)
msecs


PRAG_EGORRES9What was the Aggregate PR Interval?PR Interval, AggregateRecord the test result.TextEGORRESEGORRES where EGTESTCD = "PRAG"





PRAG_EGORRESU10What 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.TextEGORRESEGORRESU where EGTESTCD = "PRAG"(Unit)
msecs


QRSAG_EGORRES11What was the Aggregate QRS Duration?QRS Duration, AggregateRecord the test result.TextEGORRESEGORRES where EGTESTCD = "QRSAG"





QRSAG_EGORRESU12What 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.TextEGORRESEGORRESU where EGTESTCD = "QRSAG"(Unit)
msecs


QTAG_EGORRES13What was the Aggregate QT Interval?QT Interval, AggregateRecord the test result.TextEGORRESEGORRES where EGTESTCD = "QTAG"





QTAG_EGORRESU14What 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.TextEGORRESEGORRESU where EGTESTCD = "QTAG"(Unit)
msecs


QTCAAG_EGORRES15What was the Aggregate QTca Interval?QTca Interval, AggregateRecord the test result. TextEGORRESEGORRES where EGTESTCD = "QTCA"





QTCAAG_EGORRESU16What 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.TextEGORRESEGORRESU where EGTESTCD = "QTCA"(Unit)
msecs


INTP_EGORRES17What was the overall interpretation of the ECG?InterpretationRecord the the test result.TextEGORRESEGORRES where EGTESTCD = "INTP"(NORMABNM)Normal; Abnormal



EGCLSIG18Was the ECG clinically significant?Clinically SignificantRecord whether ECG results were clinically significant.TextSUPPEG.QVALSUPPEG.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

eg.xpt

RowSTUDYIDDOMAINUSUBJIDEGSEQEGREFIDEGTESTCDEGTESTEGCATEGPOSEGORRESEGORRESUEGSTRESCEGSTRESNEGSTRESUEGNAMEGMETHODEGDRVFLEGCLSIGVISITNUMVISITEGDTCEGDY
1XYZEGXYZ-US-701-0021334PT89EGHRMNECG Mean Heart RateMEASUREMENTSUPINE62beats/min6262beats/minTest Lab12 LEAD STANDARD
N1SCREENING2003-04-15T11:58-36
2XYZEGXYZ-US-701-0022334PT89PRAGPR Interval, AggregateINTERVALSUPINE0.15sec150150msecTest Lab12 LEAD STANDARD
Y1SCREENING2003-04-15T11:58-36
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





1SCREENING2003-04-15T11:58-36
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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