SD1138 not listed in FDA Validator Rules v1.3

Sergiy · December 7, 2020, 1:10pm

Hi Nari,

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

Kind Regards,

Sergiy

michael.denieu · March 31, 2021, 2:35pm

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.png SENDIG example part 2.png

Sergiy · March 31, 2021, 10:33pm

Hi Michael,

Thank you for reporting this!

We are updating SEND validation by removing SD1038 rule.

Kind Regards,
Sergiy

system · April 22, 2021, 2:57pm

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

system · December 7, 2020, 8:54am

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,

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SD1202, SD1203, SD1204 (date after RFPENDTC) not addressed in FDA's validation checks SDTM	3	8	December 10, 2014
New FDA business rules for SDTM and SEND studies News	5	11	May 25, 2018
FDA Validator Rules 1.3 Released Blogs	0	3	November 13, 2018
Validator 1.4 new validation criteria? SEND	5	9	April 2, 2013

SD1138 not listed in FDA Validator Rules v1.3

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