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Description/Overview

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.

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.

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Scenario 2: Local Reading

In this scenario, subjects' ECGs are performed and analyzed, and then the results are recorded directly on the CRF.
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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 sponsor. 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 the CRF.
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Specification

Assumptions

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