Major Feature Launches:
Major release featuring a new dashboard main page for the Evidex Signal Management module, the addition of Health Canada Vigilance data, case reports, and analytics, changes to the ICSR case report module, and a beta/preview version of all new background rate calculator.
Please Note: Actions Required:
Client and IT will need to update any Production SSO / Application links to 'https://evidex.trinetx.com/#/login' from 'https://www.adverahealth.com/explorer/#/'
Update your ADFS, AzureAD, or OKTA Evidex SSO configuration to use a new callback URL for Evidex production.
Major New Features
Evidex Signal Management Dashboard - Compliance Monitor. We have launched an all-new default home page for Evidex Signal Management featuring five panels summarizing compliance related tasks:
Calendar - A calendar view of upcoming future actions needing attention with details of associated Signals/Inquiries/Requests, Topics and Employee(s) Responsible. Each Calendar item links to Future Action details page when clicked.
What's Due - A panel that contains a list of Actions, Signal Detection Reviews and Management Reviews with upcoming and past-due due dates. Past due items will show in red. There is also a summary of ICSR and EVDAS activity, including the last date the data was refreshed, the last time the data was viewed and the next expected data refresh dates. This serves to alert users that new data requires their attention.
Team Activity - Summarizes the Actions, Signals, Inquiries, Requests and Reviews that have been completed by the PV team.
Snapshot - a nested donut chart with the inner ring displaying a real-time count of Signals, Inquiries and Requests and an outer ring displaying a breakdown of their current status.
Signal/Inquiry Activity - A time series line chart with counts of records by their current status.
All panels may be filtered using the available inputs at the top of the page to narrow the scope of what the user wants to see. Note that some criteria may not apply to all panels.
Nearly all counts and chart series displayed can be clicked to view a detailed list of the underlying records that the count represents.
Health Canada Vigilance Data. We have added Health Canada Vigilance data to Evidex (going back to 1965). These data will be updated every month. The inclusion of these data on Evidex adds safety data on 2707 products for analysis. These new data are now available for review across the following pages of the Evidex platform:
Drug Report Page – added a new subtab of the drug module showing both a summary version and a detailed summary of Health Canada case reports. Added signal and label status for each adverse event, case counts and statistics. Added Health Canada case counts and data refresh dates to the header where applicable.
2. Case Profile Page - new page with details of case reports provided by Health Canada.
3. Drug AE Analysis Page - added a new subtab of the module listing case reports linked to that specific drug/event combination.
Background Rate Calculator. We are excited to launch v1 of the all-new Background Rate Analysis tool feature that allows users to compare healthy subjects to background rates for drug-AEs across multiple sources. In v1, background rate data is currently limited to COVID AESI (Adverse Events of Special Interest) and observed case counts are limited to VAERS data only. In upcoming releases, we will incorporate background rates and observed rates from the Electronic Health Records (EHR), Claims, and other Real-World Data (RWD) assets of TriNetX to provide on-demand background rates for all drug-AE pairs identified in Evidex. This functionality will provide clients with an instant and cost-effective means to perform signal assessment and validation when first detecting a potential signal from other traditional sources.
The Background Rate Calculator can be accessed from the Evidex Home screen, or by clicking on the “Custom Analytics” drop-down menu from any Evidex page.
Other New Features
Management Reviews. New help video links posted on the List, Add Management Review, Conduct Management Review and Review Detail pages.
Surveillance - EVDAS Line Listings tab. Users can now click the 'Expanded View' button to show the data in a standard HTML table view that shows full cell contents without the need to click, vs the currently limited view the datagrids provide.
Signals/Inquiries/Requests. Added CMQ to data entry and detail pages. Only public CMQs can be added to records.
Signal data entry. Added form validation to check the status field when a closed date is supplied. Users will not be able to save changes to records until 'Closed', 'Closed (Pre-detection)' or 'New & Closed' is chosen from the status dropdown when a Signal has a Signal Closure Date. Custom 'closed' statuses (ex. 'Christine closed this') supplied by users using the status options editor will not be allowed wh
Inquiry/Request Detail. Moved 'Receipt Date' from last row of first table to the first row of the second (right hand) table above 'Closed Date'. Added 'Responsible Persons' field as the last row of the first table.
Custom Data Options. (Tools -> Utilities -> Add/Edit ESM Custom Data Options -> Add/Edit Signal Status Options). The 'New & Closed' status option is no longer editable as it is now tied to specific ESM functionality as a 'closed' status.
VAERS Module. Renamed 'Onset Interval' field to 'Onset Date'.
CMQ Editor. Restricted deletion and editing of privacy settings of CMQs that are attached to ESM Signals, Inquiries or Requests. If a CMQ is associated with a record, users will be shown a list of the records preventing the changes from being made. CMQs associated with ESM records are required to be set to public in the sharing settings. Added 'Auto Update MedDRA Terms' dropdown for owners of CMQs. Auto update flag will dictate whether deprecated MedDRA Terms will be automatically updated by the system. Clarification note added about automatic update of MedDRA Terms.
Sitewide. Most datagrid dropdown filters now feature a "-" option, that allows the user to filter the grid data to show only blank cells for that column.
Bug Fixes
Sitewide:
Fix for major white screen bug when login token would expire.
Fixes for multiselects where long item labels would overlap and hide the 'x' button that allows users to deselect an item.
Fix for datagrids only showing 5 rows when row count was less than 20.
Evidex Signal Management:
Fix for 'Load full narratives' link not working on ICSR Surveillance - DEC Summary
Fix for submitting due dates and for broken header filter on list page due to leading whitespace in the data on Management Reviews.
Signal/Inquiry/Request data entry.
Fixes for errors in form validation when checking for duplicate record IDs.
Reviews Tab
Fix for same video help button showing up multiple times
Drug Report - FAERS - Adverse Events
Fixes for 'Add to ESM' buttons.
Drug AE Analysis
Fix for header filter on the Outcomes column on FAERS Cases Tab
Trend Analysis Chart tab
Fix for count mismatch between Drug report and Drug AE Analysis.
Footnote added for clarification on chart logic.
Removed 'click to view' links on chart series that automatically run CSA to show underlying cases. The link was cause for confusion when case counts between the chart and CSA results do not match under all circumstances due to different logic on the trends chart.
Audit Log
Fix for broken report when a change had no associated actor.
Comparison Report - FAERS - Adverse Events Tab
Fix for bug that would occur when report would activate when there is no data.
Trial Report
Added ellpisis to any column header longer than 55 characters due to cosmetic bug where the text would overflow the header.