Major Feature Launches:
Evidex Signal Management (ESM) User Permissions updates
Signal Detection Plan Review updates
Evidex Signal Management (ESM) User Permissions updates
Advera added a new field to the ESM Utilities User Permissions pop-up that allows for custom user-permissions to be set. ESM admins can disallow read/write and read/write/delete users from accessing the ESM System / Data options and ESM Product utilities.
Read/write, and read/write/delete users who are disallowed from Data Options / Utilities may still access the Audit Log in the Utilities screen.
Signal Detection Plan Review updates
Advera added the ability to associate Signals, Inquiries, or Requests to Signal Detection Plan Reviews. The ability to delete reviews was also added.
The red "Delete Review" button is shown within the Conduct SDP Review page:
Minor Fixes and Enhancements:
ESM – ISCR
Added loading indicator for bulk case update.
ESM - Management Reviews
Add "Finalized Date" column to the table to show date of final sign-off.
ESM - Signal/Inquiry/Request Detail
Preserve line breaks entered into all text fields.
ESM – Signals
Add searchable text box for "Preferred Term in Evidex" box
ESM - Inquiries List
Add in "Preferred Terms in Evidex" as a column
ESM – Surveillance
Added 2020 Incidence Rates.
Add missing fields from ISCR Case Report to Surveillance Case Review.
ESM – Dashboard
Split topic columns into FAERS and ICSR with links to surveillance.
Trial Report
Order drug names by back end sort order field.
Add multiple result sources.
Drug Report
FAERS - RxSignal - Show Total Case Count column by default.
Multisource Summary - Added ICSR and EVDAS columns.
Multisource Summary - Added highlighting to IME Serious column.
Added new VAERS tab with reporting rates.
FAERS - RxSignal - Added 2020 Incidence Rates
Drug AE Analysis
Add link to filtered ICSR Surveillance - Case Review tab when clicking ICSR count.
Case Profile
New VAERS case profiles added.
Sitewide
Replace dropdown menus with free text search on Adverse Event columns quick filters.
Add Evidex version to footer.
Portfolio
Outcomes tab - Add 2020 Incidence Rates.
Clinical Meta Analysis
Added extra wait indicator for long searches.
VAERS
Added ROR (Background - Excluding Vax Type) (where c and d values exclude Vax Type).
Bug Fixes:
Drug AE Analysis
Fix for datagrid header not scrolling on second tab.
CSA Advanced Stats
Fix for previous search criteria only showing current search criteria.
Comparison Report
FAERS - when viewing "Reporting Rate" at the PT level and adding in RxSignal Status, the label status doesn't show up.
ESM audit log
From Utilities, clicking "Full Audit Log Search" yields no results. Also searching by a User Name yields no results.
Fix for same start and end date not producing results.
ESM - Signal Detail
SMQ Terms are not displaying.