NOTICE: EudraCT will reject results submissions where Arms have 0 participants started. CTGOV, however, allows for this. The implication is that Editors will need to restructure Arms when authoring EudraCT Results.
Disclose is missing the validation error message "Subjects started must be greater than 0".
If the author is not aware of this until the time the Submission is uploaded, this will cause delays and additional work to re-edit the data and get approvals.
Issue:
On the Subject Disposition tab of the ERF, there is no validation error when the number of subjects started is zero. EudraCT does not allow the number of subjects started to be zero. When the ERF submission is generated, the number of subjects is not included in the submission if the value is zero.
Workaround:
Ensure that the number started is not zero
Proposed Resolution:
ADO-2352 is open to include this ERF validation message in a future version of PharmaCM.
Fixed Versions:
Disclose 2.23.0 and higher releases