FDAC165 Unexpected MedDRA coding in the SUPPQUAL domain

Pinnacle 21 Support SDTM
1

Hi Jeanna,

SD2006 rule algorithm is adjusted to ignore QNAM=*REASOC records in Community 3.1 which will be released in few weeks.

Kind Regards,
Sergiy

P.S. We highly recommend to not use outdated versions of P21 validation engines like your Community 2.2.0

2

FDAC165 Unexpected MedDRA coding in the SUPPQUAL domain error is coming out in regards to QNAM=SVREASOC. REASOC is a variable that is mentioned for use in SUPP throughout the SDTM guide. Why is this error coming out?