eCOA/ePRO Reports

AM3 Compliance Report

The purpose of the report is to list all calculated compliance rates per patient, site, country and study overall.

AM3 Data Alert - Best PEF Report

The AM3 Data Alert - Best PEF Report lists all alerts per patient. It is on demand and includes measurement alerts from the BEST PEF trial (maximum PEF value) only and all question alerts.

AM3 Data Alert Report

The purpose of the report is to list all AM3 Questionnaires (questions and answers), the measured parameters (PEF) and all alerts per patient.

AM3 Home Transfer Alert Report

The purpose of the report is to list these patients who have not transferred data for at least 2 consecutive days per home transfer.

AM3 Study and Medication Alert Report

The purpose of the report is to list all alerts, both Study Alerts and Medication Alerts, during recording of Patient data.

AMs Not Closed Report

The purpose of the report is to identify the AM devices before they are shipped back from patients. It shows the number of AMs in use for the site and AMs not Closed.

Change from Normal Baseline ECG to Abnormal Treatment Report

This report lists the subset of patient visits where any baseline visit had an overall interpretation of "Normal" and a subsequent treatment visit was considered "Abnormal" for any reason.

COA Subject Detail Report 1 through 5

This Clinical Outcomes Assessment report is a configurable report that can be defined within each study. It is not available if a study-specific configuration has not been defined. The report can be generated for each Subject across multiple visits and often includes tables of answers to assessment questions, pre-defined scores and/or result categories (e.g. answers to a questionnaire where a subtotal score below or above a threshold value is defined as "Meets Criteria" or "Does not meet Criteria".)

COA Visit Summary Report

The purpose of the report is to display a summary of visits for all subjects for a study.

eC-SSRS 2.0 Findings Report

This report lists the subject responses and results from the Columbia Suicide Severity Rating Scale assessment.

eC-SSRS Findings Report

This report lists the subject responses and results from the Columbia Suicide Severity Rating Scale assessment.

eC-SSRS Findings/Responses Report

This report lists the subject responses and results from the Columbia Suicide Severity Rating Scale assessment.

eC-SSRS Screener Findings Report

The report provides an information summary on various levels of recent results for the eC-SSRS Screener Findings to determine the relative absence or presence of patient risk within a certain time period. The levels listed include Ideation, Behavior and Alerts and the report emphasizes the severest level of concern.

eC-SSRS Summary Report

This report summarizes the findings from the Columbia Suicide Severity Rating Scale assessment

ePRO Alert Summary Report

This report summarizes all alerts discovered during the study-specific assessments. The definition of an alert is configurable and study-specific.

ePRO Missed and Incomplete Session Report

This report lists all assessments that are currently missing or incomplete.

ePRO Session Report

This report is a configurable report that is defined for each study and the assessment collected. It is generated for each session and displays the site information, subject demography, session information including date and time, answers to the assessment questions and scoring results if any have been defined for the assessment.

ePRO Session Report V2

This report is a configurable report that is defined for each study and the assessment collected. It is generated for each session and displays the site information, subject demography, session information including date and time, answers to the assessment questions and scoring results if any have been defined for the assessment.

ePRO Session Summary Report

This report is a configurable report that is defined for each study and summarizes all the assessments collected for a specified subject and date range. It displays the site information, subject demography, session information including date and time, answers to the assessment questions and scoring results if any have been defined for the assessment.

ePRO Session Summary Signature Report

This report is a configurable report that is defined for each study and summarizes all the assessments collected for a specified subject and date range. The site information, subject demography, session information is displayed including date and time, answers to the assessment questions and scoring results if any have been defined for the assessment. The signature area is included in the report

Patient Exacerbation Alert Report

The purpose of the report is to list all alerts generated by the AM device for all patients throughout the duration of the study.