Cardiac Safety Reports

Abnormal ECGs Report

This report lists all abnormalities along with abnormality type, lead, and interval duration measurements for any ECGs with an overall interpretation of Abnormal.

Comprehensive ECG Analysis Report

This report includes all ECGs reported with complete information about the ECG including demography, date and time collected, interval duration measurements, name of the reviewing cardiologist and results of the analysis. It is displayed in pdf format.

Comprehensive ECG Analysis Report (.csv)

This report includes all ECGs reported with complete information about the ECG including demography, date and time collected, interval duration measurements, name of the reviewing cardiologist and results of the analysis. It is displayed in csv format.

Comprehensive ECG Mean Report with Comparator

The report lists the subjects and visits where a FEV1 Inter-Visit Variation Alert was displayed on the MasterScope.

ECG Metrics Report

This report lists all subjects for which ECG data has been received and includes subject demography, number of active and inactive records and number of records in report complete status. The report separates subjects by investigator and provides subtotals by site and overall

Holter Quality Report

This report provides a summary of Holter Quality comments that describe the overall quality of the recorded data. A recording is considered Good Quality if at least 80% of the recorded data demonstrates good quality. If a quality issue is discovered, other comments will be noted including Artifact, Baseline wander, High/Low amplitude, Missing leads, etc.

Summary of Abnormal ECGs Report

The purpose of the report is to summarize the abnormal ECG findings for a specific study. The report will display the count of the abnormal ECGs for different visit types. The report will also show the total number of ECGs processed to date and the total number of abnormal treatment ECGs when the baseline was normal.

Summary of Alerts Report

This report will list all transmittals that triggered any type of alert on mean, global IDM values or Findings. It displays ECGs meeting study-specific criteria defined for the protocol. If study-specific rules are not defined within the ERT data management system, this report will be blank.

Summary of Protocol Alert ECGs Report

This report will list all ECGs that triggered any type of protocol-specific alert on mean, global IDM values or Findings. It displays ECGs meeting study-specific criteria defined for the protocol. If study-specific rules are not defined within the ERT data management system, this report will be blank.

TEST Dummy Country Overview

TEST NEW RPT CREATION. The purpose is to summarize the number of subjects by the different visits in which they are presently participating.

Test Transmittal Detailed Report

This report will display all the test transmittals received per investigator, excluding sample transmittals. The report will display the summary information at the end of the report. The summary information will include the total number of External and Internal Test Transmittals for each investigator and the total number of Investigators.

Test Transmittal Report

This report displays the count of the internal and external test transmittals and the number of transmittals received. The counts will be grouped by investigators within a protocol. The report will display: Protocol Number, Investigator, Site ID, Number of Internal Test Transmittals, Number of External Test Transmittals, Number of successfully transmitted ECGs.

Tracing Quality Report

This report lists the quality category of all ECGs received including the subject demography, visit information, transmittal number, analysis date, analyst name and tracing quality (e.g. Good or Other Tracing Quality).

Trial Summary Report

This report provides a listing of summary counts of all ECG findings by Site subtotaled by category of cardiac safety abnormality. ECGs with multiple findings are counted within multiple categories.

QTc Results Detailed Review Report

This report displays any ECGs with either a QTcB or QTcF value greater than 450 ms. If the study has baseline visit(s) defined as mean comparator(s), this report will also display the change from baseline difference for the treatment visits.