CalECG Utilization (Report)

Summary

The CalECG Utilization report provides details about advanced ECG overreads across all studies, to provide insights on the number of ECGs that are processed by CalECG. This specific report is highly valuable for customers looking into (or currently in agreement with) AMPS licensing options that charge based on the number of ECG traces read/processed with CalECG. Additionally, it’s also useful in helping to get a general understanding of how CalECG is being utilized across reviewers in a given environment.

Design

This report is made available across all studies regardless of which study is selected in the study picker. As necessary, customers can role restrict the report configuration to limit it’s exposure and use across ClinSpark users.

Review Types

There are two Review Types that will be represented in the report: ‘Assessment’ or ‘Interval’.

Assessment ECGs are standard study safety ECGs that typically require PI assessment. These are reviewed in the Study > Subjects component, or, in ECG > Review > Assessments area.

Interval ECGs are associated with studies following guidance of ICH E14 for QT/QTc interval reviews workflows. These are reviewed in the ECG > Review > Intervals area.

Report Output

The report will produce a row for each ECG overread successfully completed, where CalECG was utilized as the review modality.

The report will only include ECGs that have been reviewed with CalECG, not those done using the “basic” PDF review features. It’s typically easiest to determine which review modality was used by interrogating ECG audits. Reviews done using non-CalECG methods will show ‘BASIC’ as the review system version in the ClinSpark user interface.

If the ECG is reviewed multiple times (either by same/different users), it will not be ‘double’ counted in the export. This is because the standard AMPS licensing utilization model is based on the number of ECGs reviewed and not the number of times it’s reviewed.

This condition is most likely for Interval ECGs, as multiple reviews may be done on the same timepoint due to IIRV logic.

In the event of there being an ECG reviewed multiple times, the report output will to show the most recent review details, which would include the most recent reviewer, review time, and CalECG version.

Columns

Study - Study Protocol Name. If study protocol name is not defined, will display just study name.
Subject - Study Subject Number
Visit - Study Event associated with ECG timepoint
Timepoint - Timepoint and associated Item Group number
Acquisition Time - Date/Time of when the ECG was acquired; EGDTC
Review Type - Type of review; Interval or Assessment
Review System Version - Version of CalECG used on latest review
Reviewer - ClinSpark username associated with latest review
Review Time - Date/Time associated with the latest review

Report Generation

The default icon representing this report.

Users should select the number of days used to find number of review in the page; by default options are 90, 190, 270, 360, and ‘All’.

The report output is CSV.