DD0114 - Invalid usage of split datasets for non-general-observation-class datasets

Pinnacle 21 Support Define.xml
1

Hi Gopal,

Yes, this is a false-positive message due to a bug in our validation of define.xml file.

Sorry for inconvenience.

Kind Regards,
Sergiy

2

Thanks for confirmation.

3

Hi,

We have FAxx domains [FAAE, FACE, FAMH,…] in the SDTM package. While validating define xml with P21 V3.1.0 [FDA version, SDTM IG 3.2], we are getting DD0114 message. Because as per IG 3.2, FAxx domains comes under FINDINGS ABOUT CLASS.

As per DD0114 P21 rule, FAxx domains are not comes under General Observation Class. So, we are getting this message in the report.

Please suggest, shall we consider this as False-Positive for this case?

Thanks in Advance.

Screenshots attached.

DD0114 - Invalid usage of split datasets for non-general-observation-class datasets.png
DD0114 - Invalid usage of split datasets for non-general-observation-class datasets.png1784×1596 32.4 KB