SDTM

Hi,

How do folks handle a confirmatory lab test result done on the same sample - there are 2 records for same LBTESTCD/VISIT with 2 different LBORRES. Any suggestions?

Hi all,

I have an issue withe the FDAC183 Error. We have a statins therapy which is only in text form (high intensity therapy, low intensity, etc). Currently, we are mapping it into CMDOSTXT, however, the FDA rule expects a unit to this. Why? And why is this warning an error?

Hi,

QSEVALID is meant for further information about Evaluator e.g. Initials, but Pinnacle gives this error and it is checking against Medical Evaluator codelist. This looks to me an incorrect check. 

 

My question is for --EVAL, both Evaluator and Medical Evaluator codelist apply, so can we use 2 codelist for same variable? If yes, how to represent in Define?

Thank you!

Hi Sergiy,

In CDISC December CT, ETHNIC and RACE are shown as non extensible codelist, But in pinnacle CT they are shown as Extensible. Please see below:

 

Hi There,

We are noticing some Codelists with duplicate codelist codes in the CT files downloaded from https://www.pinnacle21.com/downloads/cdisc-terminology. 

Please see below:

Following are the codelists which are not part of CDISC CT Release on December. But these are

present in pinnacle 2018-12-21 CT file. Can you provide any clarification on what are these codelists for and why do they have identical codes? 

We noticed that when using the controlled terminology from 2018-09-28 and 2018-12-21 taken from the P21 website, the warning CT2002 (“xxx value not found in 'xxx' extensible codelist”) no longer showed up in the report (when comparing the results against reports run on 2018-06-29 and earlier).

 

Pinnacle21 Validator 2.2.0 version is not throwing CT2001/CT2002 checks in output excel report when the SDTM data is validated against 2018-09-28 CT and SDTM 3.2 config file

I'm getting an SD9999 error that "Dataset AP class not recognized".  Is this because the check is not taking AP domains into account as recognized domains yet?

We were validating our data against 2018-09-28 CT and SDTM 3.2 config file and observed that Pinnacle21 validator community version 2.2.0 is not firing CT2001/CT2002 checks even though our data is incorrect. When we manually edited the format (please ref below example) for that particular CT in config file & CT file, checks got fired and we got warning/error messages (e.g SEX value not found in 'Sex' non-extensible codelist) in the report.

Hello!

I have the annotated CRF with specific domains, but for some of them there is no data. What should I do in this situation? Should the empty datasets be submitted and described in the define.xml document?

Thank you!