Issue:
In PharmaCM, under “Study Categorical Characteristics” from the “Baseline Characteristics” tab, PharmaCM may trigger the following error message incorrectly for all reported Value sets:
"Study categorical characteristic: The number of subjects for the reporting group in this categorical characteristic are not the same as the number of subjects in the baseline period. Ensure that the number of subjects recorded in the subject disposition and in the baseline characteristics are the same."
Users are advised to confirm that values have been provided for every category and the totals are in alignment with the baseline to determine if the validation error message is raised incorrectly.
Workaround:
This validation error messages can be ignored as it will not affect the successful upload of a submission to EudraCT.
Resolution:
ADO-2198 has been raised to resolve this issue in a future PharmaCM update.
Fixed Versions:
Disclose 2.23.4 and higher versions.