This example shows a CRF that collects electrocardiogram data utilizing a local reader.
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This is the SDTM data associated with the CRF above.
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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 Shows "QTcB Interval, Aggregate". This result was derived by the sponsorapplicant, as indicated by the “Y” in the EGDRVFL column. Note that EGORRES is null for these derived records. | Row 6: | Shows the result the result of the TEST "Interpretation" (i.e., the interpretation of the ECG strip as a whole), which for this ECG was ECG was "ABNORMAL". This result was assessed as clinically significant (EGCLSIG = "Y"). |
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Row | STUDYID | DOMAIN | USUBJID | EGSEQ | EGREFID | EGTESTCD | EGTEST | EGCAT | EGPOS | EGORRES | EGORRESU | EGSTRESC | EGSTRESN | EGSTRESU | EGNAM | EGMETHOD | EGDRVFL | EGCLSIG | VISITNUM | VISIT | EGDTC | EGDY |
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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 STANDARDN |
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| 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 |
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| 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 |
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| 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 |
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| 1 | SCREENING | 2003-04-15T11:58 | -36 | 5 | XYZ | EG | XYZ-US-701-002 | 5 | 334PT89 | QTCA | QTcA Interval, Aggregate | INTERVAL | SUPINE |
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| 469 | 469 | msec | Test Lab | 12 LEAD STANDARD | Y |
| 1 | SCREENING | 2003-04-15T11:58 | -36 | 6 | XYZ | EG | XYZ-US-701-002 | 12 | 334PT89 | INTP | Interpretation |
| SUPINE | ABNORMAL |
| ABNORMAL |
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| Y | 1 | SCREENING | 2003-04-15T11:58 | -36 | |
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