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Description/Overview
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ECG Test Results (EG) is a Findings domain used for electrocardiogram data, including
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position of the subject
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, method of evaluation
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, all cycle measurements
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and all findings from the ECG
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including an overall interpretation
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if collected.
This section provides EG domain metadata for 3 different data collection scenarios.
Scenario 1: Central Reading
In this scenario, results are captured directly by an electronic device and transmitted separately or read by a central vendor, rather than recorded on the CRF. The accession number and date collected on the CRF can be used as an aid in reconciliation of the electronic data.
Scenario 2: Local Reading
In this scenario, subjects' ECGs are performed and analyzed, and then the results are recorded directly on the CRF. 
Scenario 3: Central Reading with Investigator Assessment of Clinical Significance Assessment and/or Overall Interpretation
In this scenario, results are captured directly by an electronic device by a central vendor. The results are provided in an electronic file to the
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applicant. In addition, the results are provided to the investigator for assessment of clinical significance for any abnormal values, and that information is provided to the
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applicant on the CRF.
Specification
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Assumptions
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