Issue
EudraCT accepts a Submission where the Reporting Group description has not been entered. When a Submission is created from PharmaCM with an empty Reporting Group description, EudraCT displays the following validation error message under the Adverse Events section:
"ERROR: Reporting Group <XYZ> The adverse event reporting group is incomplete. Complete this field if relevant to the trial"
The issue is that the PharmaCM Submission creation process is missing a xsi:nil="true" attribute on the empty Description field which is causing EudraCT to display the validation error message.
Workaround
Option 1: After uploading and validating the Submission on EudraCT, open the Adverse Events Reporting Group with the error and click "Done" and Save.
Option 2: Request PharmaCM Support to edit your Submission XML with the xsi:nil="true" attribute which will be accepted by EudraCT. NOTE: this workaround will have to be done after each Submission creation.
Resolution
ADO-2179 has been raised to address this issue in a future PharmaCM update and will be applied to all other "nillable" fields per the EMA schema.
Fixed Version:
Disclose 2.23.4 and higher versions.