Enterprise and SD1077

p Paula

on December 16, 2016

Pinnacle21 Community reports show SD1077 (FDA expected variable not found) as a "Warning". The Enterprise Validation Report shows SD1077 as an "Error" in the FDA column.

The validation rules on the website also show SD1077 as a Warning: https://www.pinnacle21.net/validation-rules/sdtm.

I'm getting this error because Epoch is not included in SV. The study is following version 3.1.3 of SDTM.

I wanted to confirm that this is now considered an "Error" for purposes of the SDRG. Or would this be considered a "False Positive"?

Thanks

Forums: SDTM

s Sergiy

on January 5, 2017

Hi Paula, …

Hi Paula,

Yes, there is an inconsistency in SD1077 Severity. I believe that it should be an Warning. However, my interpretation of Error/Warning terms may be different.

Historically it was promoted to an Error in FDA DataFit due to some internal reasons and then it was copied to P21 Enterprise. We'll try to clarify FDA's expectations and fix inconsistency in new releases.

For purpose of SDRG there is no major difference between Error and Warning. All actual data issues must be fixed or explained regardless of their formal Severity status.

Regards,

Sergiy