ERF Validation error message displayed incorrectly on the Total # of Deaths Resulting From Adverse Events

Issue:

On the ERF > Adverse Events summary table, the "Total # of Deaths Resulting From Adverse Events" may display a validation error message in Disclose:

Deaths resulting from adverse events.

The number of fatalities causally related to the treatment for the serious adverse events collectively is less than the number of deaths resulting from adverse events. Account for all the reported deaths when reporting the serious adverse events.

This validation error message may be displayed in error even when the data is correct. The Submission XML will upload and validation successfully to EudraCT Results.

Workaround:

Please ignore this validation error message displayed in Disclose. The row "Total # of Deaths Resulting From Adverse Events" should reference the total numbers of deaths resulting from AEs, regardless of causality.

Proposed Resolution:

ADO-2331 has been raised to address this issue in a future release.

Affects Version(s):

Disclose 2.23.3.x and lower versions.

Fixed Version:

Disclose 2.23.4