d Dadaram
on

 

EPOCH value as “TREATMENT PERIOD 1” in extensible codelist But still I am getting warning “EPOCH value not found in 'Epoch' extensible codelist” Please suggest solution?

Forums: SDTM

j Joe
on October 27, 2015

I am having the same issue.  This is in OpenCDISC Community version 2.0.2.  For me, it happens in several of my extensible codelists.  It appears as if the validator does not consider the additional entries provided in the accompanying define.xml document.  I get warnings reported for values in EPOCH, EGTEST, EGTESTCD, LBTEST, LBTESTCD, RPTEST, RPTESTCD, VSTEST, VSTESTCD.

In addition, I get the same warning message for the 'Unit' codelist for PCORRESU and PCSTRESU even though those variables have been assigned the 'PKUNIT' codelist. 

j Jozef
on October 28, 2015

I do not think that the values are tested against the user defined entries in the define.xml added by the user. In my opinion, the software reads its own codelists from the directory \components\config\data\CDISC\SDTM\2014-12-19 (the latter depending on which CT version was selected).
Sergiy, can you comment?

s Sergiy
on November 3, 2015

Hi Dadaram, 

Yes, in standard Control Terminology an EPOCH codelist is extensible. That's why you got a Warning for a new term. For non-extensible codelists new terms are Errors.

There is nothing wrong in your case. You only need to explain this issue in Study Data Reviewer Guide (SDRG). Here is an example text:

"New terms were added to extensible codelist Epoch (C99079) for the study protocol needs:

  • TREATMENT PERIOD 1
  • TREATMENT PERIOD 2 "

 

Kind Regards, 

Sergiy

Want a demo?

Let’s Talk.

We're eager to share and ready to listen.

Cookie Policy

Pinnacle 21 uses cookies to make our site easier for you to use. By continuing to use this website, you agree to our use of cookies. For more info visit our Privacy Policy.