Asset Summary Report |
This report lists a summary of the status of devices and consumables that are in stock, defective or in use for each inventory item. |
Asset Summary Report for COA Equipment |
This report lists a summary of the status of COA devices and consumables that are in stock, defective or in use for each inventory item. |
Comprehensive Site Equipment Report |
The purpose for this report is to monitor orders for serialized items throughout the duration of the study. The report will list all orders for equipment shipped per Site. |
Comprehensive Site Supply Report |
The purpose for this report is to monitor orders and re-orders of supplies and other accessories for an investigator issued during the study. The report will include all non-serialized items. |
Contact Details Report |
This report will display detailed contact information about query configuration and report configuration for each contact and role. Each contact role and setup configuration will be listed as one record. |
Contact Information Report |
This report will display contact information. The list includes both active and inactive investigators and contacts. |
Country Overview Report |
The purpose is to summarize the number of subjects and visits by country. |
Data Correction Report |
The Data Correction Report lists all open data corrections. For each DCR, the report identifies the Subject and includes the query type, description, query text, query answer (if applicable), and current status. The summary lists the number of subjects for all open DCR tickets for each site including the number of subjects that have no open queries. |
Data Correction Summary Report |
The Data Correction Report - Summary will list the number of patients for all open DCR/BTR tickets for each site including the number of clean patients. |
Data Transfer Alert Report |
The purpose of the report is to list all sites that haven't transferred data for at least 14 days. |
Data Transfer Tracking Report |
The purpose of the report is to list all devices which are related to the site including the date of last data transfer and the current software version. |
Escalated Query Report |
This report provides a list of queries that are currently unresolved and in escalated status. Unresolved queries that are not escalated and resolved queries do not appear on the report. |
FeNO Home Report |
The purpose of the report is to list all FeNO Home measurements performed by a patient. |
Fev1 Change Alert Report |
The purpose of the report is to filter for patients who had an FEV1 change alert on the MasterScope device. The report will display the FEV1 change alert between the baseline and study specific visit PFT measurements. The report only checks and displays the study subjects and does not include training nor proficiency subjects. One row is displayed for each subject and alert. |
FEV1 Custom Alert Report |
The purpose of FEV1 Custom Alert report is to compare a pre-defined set of PFT tasks across visits and display an alert if the difference of FEV1 measurement between those tasks exceeds a specified threshold. |
FEV1 Inter-Visit Variation Alert Report |
The report lists the subjects and visits where a FEV1 Inter-Visit Variation Alert was displayed on the MasterScope. |
FEV1 Predicted Decrease Alert Report |
The report shows the FEV1 predicted decrease alert which displayed on the MasterScope and quality grading of the Pre-PFT measurements by subject. The purpose of the report is to filter for patients who had an FEV1 alert on the MasterScope. The threshold for the variation alert is configurable and study specific. |
FEV1 Stability Criterion Alert Report |
The report lists the subjects and visits where a FEV1 Stability Criterion has been triggered. |
FEV1 Variation Alert Report |
The report lists the subjects and visits where a FEV1 variation alert was displayed on the MasterScope. Also, the report will display the FEV1 variation alert and quality grading of the Pre-PFT and Post-PFT measurements by subject. |
Investigator Information Report |
The Investigator Information Report will display investigator information for each site including Site ID, Principal Investigator name and address. The report includes both active and inactive investigators and contact information for the site. |
Missing Visits Report |
This report provides a list of visits that are defined for the protocol to occur within a certain window of time but have not yet been received by ERT. If the site confirms via the query process that the assessment was not performed, the record will be noted with that information within this report. |
Missing Visits Report w/o Optional Visits |
This report provides a listing of visits that are defined for the protocol to occur within a certain window of time but have not yet been received by ERT. If the site confirms via the query process that the assessment was not performed, the record will be flagged with that information within this report. This report excludes all visits marked as "Optional". |
MSC Date/Time Change Monitoring Report |
The report shows manual date/time changes during the course of the study by the site users. |
Portal Activity Report |
The purpose is to list the first and last login into ERT Portal for each Portal user. |
Portal User Access Report |
This report tracks ERT Portal user access permissions and role assignment for the study. |
Query Report with Site Responses |
The report will list queries and all actions taken to resolve a query. The report includes patient and transmittal level query information, query status and any site responses to the query submitted through the Portal. |
Site Overview Report |
The purpose is to collect the number of subjects that are currently participating in the different study phases. |
Site Rollout Equipment Shipment Report |
The purpose for this report is to monitor the initial shipment of serialized and non-serialized items for the life of the protocol. |
Site Status Report |
The purpose is to list the status of each study site and information about the first and the last data transfer to ERT. |
Software Update Alert Report |
The purpose of the report is to list all devices with current software versions that differ from the expected versions for this study, country or site. |
STAT Turnaround Time Report |
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Study Metrics Report |
This report lists all subjects for which data has been received and includes subject demography, number of active/inactive records and number of records in report complete status. The report separates subjects by investigator and provides subtotals by site and overall. |
Study Monitoring Report |
This report provides a listing of transmittals received by site along with the number of screening, baseline, treatment and missed visits as well as current number of unresolved queries. |
Study Tracking Report |
This report provides a cumulative listing of all transmittals organized by investigator that includes completion dates for each step in the analysis process. |
Subject Demographic Changes |
The purpose is to list all demographic changes which are performed for each subject sorted by the site. |
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. |
Turnaround Time Report |
This report lists the number of records received and reported by each data type and includes the number and percentage reviewed within and outside of the defined study turnaround time. The TAT calculation is based on business days and excludes weekend time. Weekend time includes a period from 00:00:00 Saturday to 08:00:00 Monday (56 hours). |
Unresolved Queries over 14 days |
This report provides a list of currently outstanding queries have been unresolved for greater than or equal to 14 days, query age since creation and actions taken to resolve them. Resolved queries are removed from the report with each update. |
Unresolved Query Report |
This report provides a list of currently outstanding queries, query age since creation, and actions taken to resolve them. Resolved queries are removed from the report with each update. |
Visit Tracking Report |
This report provides a cumulative listing of all transmittals organized and subtotaled by visit. The report includes completion dates for each step in the analysis process. |