| Order | Question Text | Prompt | CRF Completion Instructions | CDASH Variable | SDTMIG Target Variable | SDTMIG Target Mapping | Controlled Terminology CodeList Name | Permissible Values | Pre-Populated Value |
|---|
| 1 | Was the ECG performed? | Was the ECG performed? | Indicate whether or not an ECG or specific ECG test was done. | EGPERF | EGSTAT |
| (NY) | Yes; No |
|
| 2 | What was the method used for the ECG? | What was the method used for the ECG? | Record the method used for the ECG. | EGMETHOD | EGMETHOD |
| (EGMETHOD) | 6 Lead Standard; 8 Lead Standard; 10 Lead Standard; 12 Lead Standard |
|
| 3 | What was the position of the subject during the ECG measurement? | What was the position of the subject during the ECG measurement? | Record the position of the subject during the ECG. | EGPOS | EGPOS |
| (POSITION) | Supine; Sitting |
|
| 4 | What was date of the ECG? | What was date of the ECG? | Record the date ECG was done using this format. | EGDAT | EGDTC |
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| 5 | What was the Mean Heart Rate? | What was the Mean Heart Rate? | Record the test result. | EGHRMN_EGORRES | EGORRES | EGORRES where EGTESTCD = "EGHRMN" |
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| 6 | What was the unit of the Mean Heart Rate? | What was the unit of the Mean Heart Rate? | Record or select the original unit in which these data were collected, if not pre-printed on CRF. | EGHRMN_EGORRESU | EGORRES | EGORRESU where EGTESTCD = "EGHRMN" | (Unit) |
| beats/min |
| 7 | What was the Aggregate PR Interval? | What was the Aggregate PR Interval? | Record the test result. | PRAG_EGORRES | EGORRES | EGORRES where EGTESTCD = "PRAG" |
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| 8 | What was the unit of the Aggregate PR Interval? | What was the unit of the Aggregate PR Interval? | Record or select the original unit in which these data were collected, if not pre-printed on CRF. | PRAG_EGORRESU | EGORRES | EGORRESU where EGTESTCD = "PRAG" | (Unit) |
| msecs |
| 9 | What was the Aggregate QRS Duration? | What was the Aggregate QRS Duration? | Record the test result. | QRSAG_EGORRES | EGORRES | EGORRES where EGTESTCD = "QRSAG" |
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| 10 | What was the unit of the Aggregate QRS Duration? | What was the unit of the Aggregate QRS Duration? | Record or select the original unit in which these data were collected, if not pre-printed on CRF. | QRSAG_EGORRESU | EGORRES | EGORRESU where EGTESTCD = "QRSAG" | (Unit) |
| msecs |
| 11 | What was the Aggregate QT Interval? | What was the Aggregate QT Interval? | Record the test result. | QTAG_EGORRES | EGORRES | EGORRES where EGTESTCD = "QTAG" |
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| 12 | What was the unit of the Aggregate QT Interval result? | What was the unit of the Aggregate QT Interval result? | Record or select the original unit in which these data were collected, if not pre-printed on CRF. | QTAG_EGORRESU | EGORRES | EGORRESU where EGTESTCD = "QTAG" | (Unit) |
| msecs |
| 13 | What was the Aggregate QTca Interval? | What was the Aggregate QTca Interval? | Record the test result. | QTCAAG_EGORRES | EGORRES | EGORRES where EGTESTCD = "QTCA" |
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| 14 | What was the unit of the Aggregate QTca Interval? | What was the unit of the Aggregate QTca Interval? | Record or select the original unit in which these data were collected, if not pre-printed on CRF. | QTCAAG_EGORRESU | EGORRES | EGORRESU where EGTESTCD = "QTCA" | (Unit) |
| msecs |
| 15 | What was the overall interpretation of the ECG? | What was the overall interpretation of the ECG? | Record the the test result. | INTP_EGORRES | EGORRES | EGORRES where EGTESTCD = "INTP" | (NORMABNM) | Normal; Abnormal |
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| 16 | Was the ECG clinically significant? | Was the ECG clinically significant? | Record whether ECG results were clinically significant. | EGCLSIG | EGCLSIG |
| (NY) | Yes; No |
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