g Gopal
on

 

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.

Forums: Define.xml

Sergiy
on November 26, 2020

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

g Gopal
on November 26, 2020

Thanks for confirmation.

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