SD1138 not listed in FDA Validator Rules v1.3

n Nari

on December 7, 2020

hi,

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?

Sincerely,

Attached Files

fda-Validator-Rules_v1.3.png

P21_Validator_Report.png

Forums: SEND

Sergiy

on December 7, 2020

P21

Hi Nari, SD1128 is CDISC…

Hi Nari,

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

Kind Regards,

Sergiy

m Michael

on March 31, 2021

CG0348 is a SDTM conformance rule not a SEND conformance rule

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 1 SENDIG example part 2