n Nari



SD1138 is not listed in FDA Validator Rules v1.3, but has been validated in the validation report.
Could you tell me why SD1138 is verified?


Forums: SEND

on December 7, 2020

Hi Nari, 

SD1128 is CDISC rule CG0348. FDA does not publish standard compliance rules.

Kind Regards,


m Michael
on March 31, 2021

Hi Sergiy,

I understand the application of this rule to clinical data as it is part of the CDISC SDTM conformance rules, however it is not a SEND conformance rule. Further, this is directly contradicted by the example of its usage in the 3.1 SENDIG (see below row 4). It seems inappropriate to apply this rule to SEND validation.SENDIG example part 1SENDIG example part 2

on March 31, 2021

Hi Michael, 

Thank you for reporting this!

We are updating SEND validation by removing SD1038 rule.

Kind Regards,

d Debra
on April 22, 2021

This is removal of rule SD1138, not SD1038, correct?

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