Major release containing significant changes to Case Series Analysis, Case Profile Annotation/Commenting and File attachment functionality added to ESM.
Case Series Analysis - New tab navigation, search criteria, & review functionality
Case Profile - New Comments capabilities
Evidex Signal Management (ESM) - New add file attachment capabilities
Tools Menu - New file manager & Utilities menu
New tab navigation added - submit buttons have been removed from the form. Now, the form will be submitted by navigating to one of the results tabs. A note has been added at the bottom of the search form for users searching for the old button - "Click the navigation tabs at the top to submit your search criteria."All save and load functionality is available from each tab now. Previously, you could only load saved searches from the search form page.
New Export Options have been added to Case Review, PT Details and Outcomes tabs under the 'Result Options' menus. Users can now export a .csv file via email, or attach the file to an Evidex Signal Management (ESM) Signal, Inquiry, Request, Action or Review
New options added for filtering by MOA, Class, Indication, HLT, HLGT, and SOC MedDRA levels.
New options for filtering on TTO (Time to onset, Event Latency Days) in the Date Information section
Case Review tab - (previously was the unnamed CSA results page)
New column added for Time to Onset - "TTO (Event Latency Days)".
Clinical Trial info section has been removed (replaced by Clinical Meta Analysis search).
Outcome percentages section has been moved to its own results tab.
Moved ROR 'click to request' functionality to the PT details tab
Case profiles have 3 new user defined flags that can be set directly from the Case Review tab.
-Data Mining - include/exclude from CSA stat calculations
-Case Series - to be used in conjunction with the datagrid header filters to explicitly include/exclude cases from the result set (on this tab only)
-Status - These options are user defined. They can be accessed from Tools -> Utilities -> Add/Edit Case Profile Status Options
New PT Details tab
Features statistical values for ROR, PRR, and Chi-squared (w Yates correction) [For the entire result set and a data grid with ROR and PRR broken up by Adverse Event.
New Outcomes tab
Contains the outcomes section previously seen on the CSA results page.
New Manage Snapshots tab
From here, users can create point-in-time snapshots of results that can be viewed at any time in the future. These results will not change when the database is updated. This can be used to compare results over time.
This tab shows all snapshots created by a users organization. Users can only delete or rename their own snapshots.
When creating a snapshot, the back end will generate and save results for the Case Review tab, PT Details tab, and Outcomes tab.
Due to extended search times in some cases, users will see a message to view the current status of the result generation. When a snapshot is ready to be viewed, a 'Load Results' link will show instead of a status message.
A new Settings/Comments section will now appear at the top of the report. These flags are set for an entire organization on an individual case basis and can be set on both the Case Profile page and CSA:
Data Mining (Include) - This flag will determine whether the case will apply in stat calculations.
Case Series (Include) - This flag can be set and used to filter out cases on the CSA - Case Review data grid.
Status - These options are user defined. They can be accessed from Tools -> Utilities -> Add/Edit Case Profile Status Options
The PDF Export button has been moved to the new 'Options' drop down menu.
Added new PDF Export options for 'Export PDF via email' and 'Export PDF to ESM' features.
Removed any references to FOIA and "Evidex Data Source"
New Commenting system:
Added new Commenting functionality for cases. Comments can be set to Private/Not Shared, Public (Shared with your organization), or Shared with specific users.
Comments will require a 'Status' to be specified. The options in the dropdown list can be edited and will apply to the whole organization using a new Custom Data Options editor (previously only seen in ESM admin custom data options).
Editing Options: The editor can be accessed by clicking the 'Click to edit these options' link located next to the comment types dropdown on the commenting modal. Users can also click on TOOLS at the top right of any Evidex page, then "Utilities" and finally "Add/Edit Case Profile Status Options".
New field annotation functionality:
Annotations can now be added to any field on Case Profile (and CSA) by clicking the edit icons next to a field value.
This includes a modal commenting system for managing individual annotations and history.
Annotations can be toggled by using the 'Toggle Annotations' item in the new case profile 'Options' menu in the header.
ESM
Users are now able to add file attachments to any record type (Signals, Inquires, Requests, Actions, Reviews)
Previously, the Supporting Documents sections only allowed for web links. Now it supports both web links and file attachments.
Safety Relevant Observations tab is now filtered by SRO Status ("Actives" are shown by default).
New attachment options have been added to CSA and Case Profile to directly export csv & pdf files to ESM records. These options are available under "Result Options" menus on CSA results and on the Case Profile page in the "Options" menu.
This feature (previously only seen in ESM) has been refactored to work with changes made to the case profile.
Tools Menu
New File Manager - Shows a list of all uploaded files for an organization.
New Utilities Menu - This is similar to the ESM Utilities Tab where user defined options can be set