Major release version featuring the new ESM Management Reviews module, and some minor changes to ICSR Surveillance.
New Features
Sitewide
Added Help link in the header that links to help.adverahealth.com. [AEA-3204]
Added 'Export to excel' to all data grids (vs previous ability to only export to csv. or pdf).
Added in-app help video modals.
Restrict Read-Only users from uploading files.
Evidex Signal Management
Dashboard
Added Management Review Section.
Show 50 Future Actions by default (vs. previous 3).
Added Completed Actions section.
Signals, Inquiries and Request list pages
Added column for 'Responsible Persons' to the data grids.
Management Reviews
New, more robust version of the old review system (now referred to as Legacy version).
Users/organizations with legacy reviews already created will retain access to that system in addition to the new system. For new users/organizations, legacy reviews will be hidden.
Review Invitation
This new version allows assigning users for up to 3 sign off levels - two interim levels (optional) and one final sign off level (required).
Users can choose from existing record types to include in the review, and a timeframe to specify which records to be automatically added for review.
Users can save reviews as templates to be used to streamline future reviews. Templates can only be defined using a preset date range. Custom date ranges are not allowed.
Conduct review page
After an invitation has been sent, the user will be redirected to the 'Conduct Review' page, which automatically pulls ESM records specified in the invitation step.
The creator of the review may manually hide any records they want by clicking the 'eye' icon. This icon is only visible to the review initiator.
Only the creator of a review will have the ability to delete it.
Users assigned to the current sign-off level will be able to approve or reject individual records.Bulk approval and rejection buttons are available at the top of the page to avoid having to manually approve or reject all records one at a time.
Users can not sign off on a review level until all records have been approved. Users have the ability to comment on any record in the list, or add a general comment for the entire review.
Users have the ability to send emails to other users assigned to the review and review which emails were sent to whom in the email history table. Once all users have signed off on the current sign-off level, the review will automatically progress to the next sign off level (if applicable).
Users have the ability to show all record details in an aggregate view for the purposes of PDF export. PDF Export can either be done using the red 'View PDF' button in the tab navigator, or by using their browsers Print to File capability. For performance reasons, it is recommended that users use the native browser PDF export ability, however, using the red PDF button will yield better formatting/readability on the end result. There can be significant time differences in the time it takes to render either option.
Reviews list page
Users/organizations with legacy reviews created will see two tables here. One for the legacy version and one for the new Management Reviews version. Users/Organizations with no legacy reviews will not see the legacy section.
A users name will be highlighted in red in the "Hasn't Signed Off" column to more readily see the reviews they're currently responsible for signing off on.
Legacy Reviews - Show "Completed" in the "Sign Off" column instead of a dash when review is complete.
ICSR Surveillance
A new 'Case Advanced Search' button has been added to highlight the advanced filtering feature (as opposed to the relatively hidden dropdown menu item which is still available).
Removed "Manage Products" menu utility. The products shown on ICSR Surveillance will be controlled using the ESM Product Manager utility by associating MCN Products with ESM Products.
Fix for dates erroneously showing 1969 in Case Review
Periodic Email Reminders
Emails have been standardized to run at 5:05am PT.
ICSR Case Profile
Values in the Drug Details table will be highlighted in red when the value is 'Yes'.
Moved 'Event Latency Days' and 'AESI' from the Reaction Information table to the Drug/Event Information table.
Added Drug History Table containing Drug Start Date and Product Name
Split narrative text into two-column tabloid style. It was too hard to read on wide screens. [
Removed constraint in Drug/Event information which required a Reported Causality value for row to show.
Corrected formatting/proper value retrieval for received date, study ID, MedDRA version.
Portfolio Drug Detail
Added 2019 revenue.
Bug Fixes
Sitewide
Fix for error caused by ad blockers due to a file named 'metrics'.
Performance fixes for main site search boxes.
Homepage
Fix for footer overlapping content on smaller devices.
ESM
Dashboard
Fix for future action display estimate date.
Product editor
Fix for unresponsive products selector box due to too many items.
Fix for previously saved MCN products not loading on the editor modal.
Renamed "MCN Product" to "ICSR Product"
ICSR Surveillance
(Regression) - Fix for "=TEXT" showing in csv output. This is a previous hack to prevent excel from showing Case Numbers as scientific notation. An excel export option has been added to all datagrids as an alternative fix.
Signal/Inquiry/Request detail
Fix for estimated completion dates not showing properly. [AEA-3095]
Portfolio Detail Overview
Fix for revenue columns not displaying properly.
CSA
Fix for 'Company Sending Report' not loading properly.
Advanced stats - auto-refresh the results status table.