Release 1.51 focuses improvements on the Signal Detection process in Evidex by bringing automation, flexibility, and simplicity to this critical workflow. Additionally, we are adding additional control in Signal Management activities by adding Product-Based Permissions for specific Signal Management activities.
The following is an outline of the updates in release 1.51:
· Updates Affecting Signal Detection Review Users
o [New Feature] Signal Detection Review Workflow
§ New Rules-Based Static Data Tables Automatically Generated for Every Review
§ Data Snapshot for Signal Detection Reviews
§ Linking Signal Detection Rules to Plans
§ Sequential Signoffs
§ New Interface for Signal Detection Reviews*
§ Signoff via One Time Passcode*
§ New “Review Type” Field
§ New Data Views
· Signal Detection
· Case Narrative
· DEC Trending
§ Addition of unique identifier (UUID) to Support Signoff Documentation*
o [Enhancement] Signal Detection Plan Updates*
§ Biennial and Biannual Frequencies for Signal Detection Plans
§ Non-Calendar Review Dates for Quarterly, Biennial, Annual, and Biannual Signal Detection Plan Frequencies
§ Update of From/To Date Selectors for Frequencies Longer than Every 2 Weeks
· Updates Affecting Users of ICSR Surveillance:
o [New Feature] Product-Based Permissions for Signal Management Activities
§ Request Detail and Requests
§ Inquiry Detail and Inquiries
§ Main Dashboard
§ ESM Compliance Monitor
§ Actions
§ Signal Detail Report
§ DEC Summary
§ Signals List
§ Update to Product Utility Label for Signal Management*
o Miscellaneous Fixes/Updates*
§ [Enhancement] Expand Number of Characters for Narrative on CSV Export
· Deprecated Features*
o Compare Menus for Data Sources on Drug List
o Bulk Signoff for Signal Detection Reviews
o Bulk Attachment of Supporting Documents in Signal Detection Reviews
o View PDF for:
§ Main Dashboard
§ Drug Detail
§ PBRER
§ Management Review
§ Legacy Review
§ Inquiry Detail
§ Request Detail
§ Signal Detail
§ Actions Detail