Pinnacle 21 error for IETESTCD Label

Sergiy

on November 7, 2019

P21

It was a bug we've just fixed due to your report

Hi Priyanka, 

I assume that you refer to TI domain in SDTM-IG 3.2 specs. It was a bug we've just fixed due to your report.

Thank you for your help!

Sergiy

Hi Sergiy, Thanks for your…

Hi Sergiy,

Thanks for your feedback. The label is assigned as per SDTM IG 3.2. Can we ignore the issue conisdering a bug in the P21 validator? Will the bug be resolved in the next release of the software?

Sergiy

on November 8, 2019

P21

P21 implementation is correct. See CDISC Errata

Hi Pryanka, 

I am sorry for my confusion. I did not check CDISC Errata for SDTM IG 3.2 https://wiki.cdisc.org/display/PUB/SDTMIG+v3.2+Errata

According to this document: 

Section 7.4 - Trial Summary And Eligibility

• Page 1 (noportfolio page 350) / Ti – Specification for Trial Inclusion/Exclusion Criteria Dataset: 
  • The "I" of "TI" in this section heading should be capitalized. 
  • The value in the "Variable Label" column for IETESTCD should be changed from "Incl/Excl Criterion Short Name e" to "Inclusion/Exclusion Criterion Short Name".

Our implementation of Label for IETESTCD variable was done correctly according to CDISC as "Inclusion/Exclusion Criterion Short Name" and it will be still like that. "Inclusion/Exclusion Criterion Short Name"

Kind Regards, 

sergiy