On the same data files, I generated a report with the new P21 version 4.0.0 (validation engine FDA 2204.0) and compares this new report with a previous one generated with P21 3.1.2 (Validation 2010.1).

It appears that in the new report with P21 4.0.0, I find all the issues raised in the report generated with version 3.1.2 with the exception of messages related to SD1117 (Duplicate records).

I do not understand why this message no longer appears when I previously had this message in several SDTMs and these have not changed.

Do you have an explanation?

Thank you very much for your answer

Forums: Troubleshooting and Problems

on April 27, 2022

Hi Eric, 

Thank you for reporting this issue! It looks like a bug in SD1117 rule which works only for EG domain now. We will try to update 2204.0 engine asap.

Kind Regards,

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