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?
EGPERFEGSTAT
<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).
EGDATEGDTC
_ _ / _ _ _ / _ _ _ _
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).
EGTIMEGDTC
_ _ : _ _ : _ _
EGHRMN_EGORRESEGORRES where EGTESTCD = "EGHRMN"
Pre-populated
beats/min
EGHRMN_EGORRESUEGORRESU where EGTESTCD = "EGHRMN"
Pre-populated
msecs
<Unit codelist>
Record the test result.
PRAG_EGORRESEGORRES where EGTESTCD = "PRAG"
_________________
PRAG_EGORRESUEGORRESU where EGTESTCD = "PRAG"
Pre-populated
msecs
<Unit codelist>
Record the test result.
QRSAG_EGORRESEGORRES where EGTESTCD = "QRSAG"
_________________
QRSAG_EGORRESUEGORRESU where EGTESTCD = "QRSAG"
Pre-populated
msecs
<Unit codelist>
Record the test result.
QTAG_EGORRESEGORRES where EGTESTCD = "QTAG"
_________________
QTAG_EGORRESUEGORRESU where EGTESTCD = "QTAG"
Pre-populated
msecs
<Unit codelist>
Record the test result.
QTCAAG_EGORRESEGORRES where EGTESTCD = "QTCA"
_________________
QTCAAG_EGORRESUEGORRESU where EGTESTCD = "QTCA"
Pre-populated
msecs
<Unit codelist>
Record the the test result.
What was the overall interpretation of the ECG?
INTP_EGORRESEGORRES where EGTESTCD = "INTP"
<NORMABNM codelist>
Record whether ECG results were clinically significant.
Was the ECG clinically significant?
EGCLSIGSUPPEG.QVAL where SUPPEG.QNAM = "EGCLSIG" and SUPPEG.QLABEL= "Clinically Significant" and EGTESTCD= "INTP"
<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
Query Display
List Style
Hidden
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 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
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
12
XYZ
EG
XYZ-US-701-002
12
334PT89
INTP
Interpretation
SUPINE
ABNORMAL
ABNORMAL
1
SCREENING
2003-04-15T11:58
-36
Dataset Debug Message
There are six leading, trailing, or non-breaking spaces in the dataset.