Summary:
The minor release 1.51.1 focuses on implementing feedback from release 1.51’s Signal Detection Review enhancements. This includes adding additional features to make case review easier in Signal Detection Reviews, enhance visibility into Signal Detection Review Data, and a new feature to allow easier compliance tracking for Signal Detection.
Updates Affecting Signal Detection Review Users
[Enhancement] Signal Detection Review Workflow
Case Narrative View:
Addition of Case Status and Case Comment Data
Dec Trending View
DEC Trending View Renamed to Interval View
All Views:
Addition of Rule Triggered to Data Grids
Addition of Row Counts for Data Grids
Addition of Data Pagination for Large Datasets
Addition of Links to Drug/AE Pages
Review Criteria Added as Additional Section
[New Feature] Signal Detection Review Monitor Page
Updates Affecting EVDAS Users
[Enhancement] EVDAS Line Listings Page Limited to 2500 Records
Updates Affecting Signal Management Users
[Enhancement] FAERS Safety Relevant Observations Product Selector
[Deprecated] Export to PDF Removed from Grids
Updates Affecting Signal Detection Rule Users
[Enhancement] Update for Case Classification and Event Seriousness Value Selector