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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 2-4: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.
Rows 5-6:Show "QTcB Interval, Aggregate" and "QTcF Interval, Aggregate". These results were derived by the sponsor, as indicated by the “Y” in the EGDRVFL column. Note that EGORRES is null for these derived records.
Rows 7-10:Show results from tests looking for certain kinds of abnormalities, which have been grouped using EGCAT = "FINDINGS".
Row 11:Shows a technical problem represented as the result of the test "Technical Quality". Results of this test can be important to the overall understanding of an ECG, but are not truly findings or interpretations about the subject's heart function.
Row 12:Shows the result of the TEST "Interpretation" (i.e., the interpretation of the ECG strip as a whole), which for this ECG was "ABNORMAL".

eg.xpt

eg.xpt

RowSTUDYIDDOMAINUSUBJIDEGSEQEGREFIDEGTESTCDEGTESTEGCATEGPOSEGORRESEGORRESUEGSTRESCEGSTRESNEGSTRESUEGNAMEGMETHODEGDRVFLEGCLSIGVISITNUMVISITEGDTCEGDY
1XYZEGXYZ-US-701-0021334PT89EGHRMNECG Mean Heart RateMEASUREMENTSUPINE62beats/min6262beats/minTest Lab12 LEAD STANDARD
N1SCREENING 2003-04-15T11:58-36
2XYZEGXYZ-US-701-0022334PT89PRAGPR Interval, AggregateINTERVALSUPINE0.15sec150150msecTest Lab12 LEAD STANDARD
Y1SCREENING 2003-04-15T11:58-36
3XYZEGXYZ-US-701-0023334PT89QRSAGQRS Duration, AggregateINTERVALSUPINE0.103sec103103msecTest Lab12 LEAD STANDARD

1SCREENING 2003-04-15T11:58-36
4XYZEGXYZ-US-701-0024334PT89QTAGQT Interval, AggregateINTERVALSUPINE0.406sec406406msecTest Lab12 LEAD STANDARD

1SCREENING 2003-04-15T11:58-36
5XYZEGXYZ-US-701-0025334PT89QTCAQTcA Interval, AggregateINTERVALSUPINE

469469msecTest Lab12 LEAD STANDARDY
1SCREENING 2003-04-15T11:58-36
12XYZEGXYZ-US-701-00212334PT89INTPInterpretation
SUPINEABNORMAL
ABNORMAL





1SCREENING 2003-04-15T11:58-36

Dataset Debug Message

There are six leading, trailing, or non-breaking spaces in the dataset.

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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