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 23-4: | 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 Row 5-6: | Show "QTcB Interval, Aggregate" and "QTcF Shows "QTcB Interval, Aggregate". These results were This result was derived by the sponsorapplicant, as indicated by the by the “Y” in the EGDRVFL columnEGDRVFL 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 116: | 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 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 STANDARD | N |
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| 1Screening 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 STANDARDY |
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| 1Screening 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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| 1Screening 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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| 1Screening 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 |
| 1Screening 1 | SCREENING | 2003-04-15T11:58 | -36 | 126 | XYZ | EG | XYZ-US-701-002 | 12 | 334PT89 | INTP | Interpretation |
| SUPINE | ABNORMAL |
| ABNORMAL |
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| Y | 1Screening 1 | SCREENING | 2003-04-15T11:58 | -36 | |
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