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Description

A findings domain that contains ECG ECG Test Results (EG) is a Findings domain used for electrocardiogram data, including position of the subject, method of evaluation, all cycle measurements and all findings from the ECG including an overall interpretation if collected or derived.

The CDASHIG EG domain includes ECG data, including the position of the subject; method of evaluation; all cycle measurements; and all findings from the ECG, including an overall interpretation, if collected.

This section provides EG domain metadata for 3 different data collection scenarios.

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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 sponsorapplicant. 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 sponsor on applicant on the CRF.

Specification

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