Scheduled Date for Validation Environment: N/A
Scheduled Date for Production Environment: March 27, 2023
Summary:
Evidex Release 1.48.2 is a is a hotfix release to address 5 defects for 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.
ICSR Case Review - New/All Cases Filter Not Functional
Section Affected
Evidex Signal Management - Surveillance – ICSR – Case Review
URS/FRS Requirement
ADV-SURV02
Description
There was an issue with the Evidex Signal Management - Surveillance – ICSR module. When users visited the ICSR - Case Review tab on production, the "New Cases" and "All Cases" filter was not working properly and was returning the same number of cases for both "new" and "all."
Steps to reproduce:
Go to Evidex Signal Management - Surveillance – ICSR module.
Click on the Case Review tab.
Click on “New Cases” filter (Figure 1).
Expected: Shows only new cases
Actual: Returning “Total Cases” (not New Cases = latest batch)
Figure 1
Resolution
This issue was resolved by ensuring that the new cases and all cases filter on the Case Review tab was returning the correct number of cases. Resolution was achieved via a code change.
Audit Log for a signal does not include supporting documents just created.
Section Affected
Evidex Signal Management – Audit Log Functionality
URS/FRS Requirement
ADV-69A.5, ADV-21CFR11-3, ADV-21CFR11-3.1, ADV-21CFR11-3.2
Description
There was an issue with the Evidex Signal Management module, where the audit log for signals did not capture supporting documents that were added and then, subsequently, deleted (Figure 2,3).
Steps to reproduce:
Go to a signal.
Go to the signal edit page.
Go to the supporting documents section at the bottom of the page.
Add a supporting document by choosing a file and selecting upload.
Save the signal with the new document attached.
Go back into to edit that signal again.
Delete the document that was just added.
Save the signal again.
Go to audit log by clicking review edit history for that signal.
See that there is no history of that document being added ever or deleted. Just a blank.
Figure 2
Figure 3
Resolution
This issue was resolved by ensuring that the changes to supporting documents for signals were captured in the audit log. This resolution was achieved via a code change in the audit log module.
Alert Functionality on Actions reported as not being received from Sandbox EU Environment.
Section Affected:
Evidex Signal Management – Alert Functionality
URS/FRS Requirement
ADV-43, ADV-43.1-43.8
Description
There was an issue with the Evidex Signal Management module, where some clients did not receive alerts for created actions.
Resolution
This issue was resolved via assistance with a 3rd party vendor, in order to ensure that EU users are correctly receiving alerts for created actions in the Sandbox EU environment. Resolution was achieved via a support request to a 3rd party vendor.
EVDAS eRMR/Line Listings not showing up correctly for specific product
Section Affected
Evidex Signal Management - Surveillance – EVDAS
URS/FRS Requirement
ADV-SURV03.1, ADV-SURV03.2, ADV-SURV03.3, ADV-113, ADV-114
Description
There was an issue with the EVDAS module where selection of the product, metformin, was not loading the eRMR and line listing data correctly.
Steps to reproduce:
Connect to client ESM
Go to ESM > Surveillance > EVDAS > eRMR
Select “METFORMIN” in the product dropdown
Search for “Abdominal pain” in the Adverse Event filter
Observe new / total EVPM
Click on the new/total to be redirected to Line Listings page
Expected: count on line listings page more or less matches what was seen on eRMR page
Actual: 0 results on line listings page
Resolution
This issue was resolved by ensuring that the EVDAS eRMR and line listing data loads correctly for the selected product. Resolution was accomplished via a code change.
Signal detection rules are not populating with cases when clicking on Rules Cases from ICSR Surveillance.
Section Affected
Evidex Signal Management – Surveillance - ICSR – Signal Detection Rules Summary
URS/FRS Requirement
ADV-181, ADV-181.1-181.5
Description
There was an issue with the ICSR – Signal Detection Rules module where the case details for a newly created signal detection rule were not loading correctly. (Figures 4,5).
Steps to reproduce:
Click on Evidex signal mgmt from home page
Click on Surveillance tab → +Add rule sub tab
Must have: IME/DME (Select IME only)
Must Have Outcomes (Fatal selected only)
Clicked save
Clicked on Signal detection rules sub-tab
Clicked on newly created signal detection rule (IME + Fatal)
Clicked on Rule Cases (4) for Encephalopathy
Blank table displays for Case Review page
Expected: Selected rule cases should load the correct case details.
Actual: Case details loads a blank page.
Figure 4
Figure 5
Resolution
This issue was resolved by ensuring that clicking on the selected rules cases value loads the correct case details. Resolution was accomplished via a code change and re-application of a data transformation.