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?
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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.
Attached Files