4 Radnor Corporate Center
Suite 350
Radnor, PA 19087
+1 (888) 507-2270
DSDECOD validation for rules CT2002 and FDAC341
s
Sergiy
on December 17, 2014
Hi Joe, Thank you for
Hi Joe,
Thank you for reporting this issue!
There are two missing Value Level assignments in current validation configurations.
DSDECOD, where DSCAT="DISPOISTION EVENT" (old CT0025 check)
SCSTRESC, where SCTESTCD="MARISTAT" (old CT0024 check)
We'll fix this bug in the next Auto-update configurations.
Kind Regards,
Sergiy
I am getting some warning messages in the Validator 2.0 for DSDECOD values that are not found in the Completion/Reason for Non-Completion codelist. The controlled terminology for DSDECOD should be based on what the DSCAT value is for each record. DSDECOD values of "INFORMED CONSENT OBTAINED" and "RANDOMIZED" should be permitted without a warning message when the DSCAT is "PROTOCOL MILESTONE". You may also need to allow for other values when DSCAT is "OTHER EVENT".
For reference, this is in OpenCDISC Validator 2.0, engine version 2.0.0 using the SDTM 3.2 configuration with CT version 2014-09-26.