This example shows a CRF that collects electrocardiogram data utilizing a local reader.
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| title | aCRF: Electrocardiogram |
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| 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 |
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| 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 |
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| | 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 |
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| | 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 |
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| | EGDAT | 4 | What was date of the ECG? | ECG Date | Record the date ECG was done using this format (DD-MON-YYYY). | Date | EGDTC |
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| | 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 |
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| | 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 |
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| | EGHRMN_EGORRES | 7 | What was the Mean Heart Rate? | ECG Mean Heart Rate | Record the test result. | Text | EGORRES | EGORRES where EGTESTCD = "EGHRMN" |
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| beats/min |
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| | 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 |
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| | PRAG_EGORRES | 9 | What was the Aggregate PR Interval? | PR Interval, Aggregate | Record the test result. | Text | EGORRES | EGORRES where EGTESTCD = "PRAG" |
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| | 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 |
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| | QRSAG_EGORRES | 11 | What was the Aggregate QRS Duration? | QRS Duration, Aggregate | Record the test result. | Text | EGORRES | EGORRES where EGTESTCD = "QRSAG" |
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| | 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 |
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| | QTAG_EGORRES | 13 | What was the Aggregate QT Interval? | QT Interval, Aggregate | Record the test result. | Text | EGORRES | EGORRES where EGTESTCD = "QTAG" |
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| | 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 |
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| | QTCAAG_EGORRES | 15 | What was the Aggregate QTca Interval? | QTca Interval, Aggregate | Record the test result. | Text | EGORRES | EGORRES where EGTESTCD = "QTCA" |
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| | 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 |
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| | 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 |
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| | 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 |
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This is the SDTM data associated with the CRF above.
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