Validation Environment Release Date: N/A
Production Environment Release Date: March 17, 2023
Summary:
Evidex Release 1.48.1 is a hotfix release to address 2 defects affecting the Evidex Signal Management - Surveillance – EVDAS and the Background Rate Analysis Tool.
Issues:
Validation Guidance
We recommend customers should check their requirements and testing to see if any updates are needed for their validation package.
If you have any questions, please contact your Evidex account manager or reach out to evidex@trinetx.com for assistance.
Surveillance > EVDAS Grid collapsed by default and can't expand when data is present
Section Affected
Evidex Signal Management - Surveillance – EVDAS
URS/FRS Requirement
ADV-113, ADV-113.1
Description
There was an issue with the Evidex Signal Management - Surveillance – EVDAS module, where the data grid was not viewable for some users because it collapsed by default.
Steps to reproduce:
Select ESM user
Navigate to ESM > Surveillance > EVDAS
Select a product with EVDAS data
Expected: Grid displays data are visible / grid has a reasonable height.
Actual: Grid is not viewable / totally collapsed (Figure 1).
Figure 1
Resolution
This issue was resolved by ensuring that the data grid expands to a viewable height for users (Figure 2).
Figure 2
User Permissions Issue with the Background Rate Analysis Tool
Section Affected
Evidex – Background Rate Analysis Tool
URS/FRS Requirement
Appendix B
Description
There was a user permissions issue with the Background Rate Analysis Tool, where some users that were granted access to this tool were still unable to access it.
Steps to reproduce:
Login with user account that was granted access to the Background Rate Analysis Tool
Select Background Rate: Source, Indication, Adverse Event
Expected: Navigation tabs to submit search criteria.
Actual: Don’t see any navigation tabs to submit search criteria (Figure 3).
Figure 3
Resolution
This issue was resolved by ensuring that users that were granted access to the Background Rate Analysis Tool had the correct user permissions set up and were able to submit search criteria via the navigation tab ("Background Rate Summary") (Figure 4).
Figure 4
