SDTM

Hi,

We have a CRF which captures information if Vomitting or DIARRHOEA has occurred since last visit . This question is asked at every visit (Visit 2-Visit 6).

Hi,

Can anyone advise which SDTM domain should we map Breastfeeding data?

Thanks,

Priyanka 

I have uploaded my SDTMs to P21 and created the define file.      In the SDTM issues I am getting a warning that VSTESTCD value not found in Vital signs Text Code extensible codelist.    When I go to the terms in my define, the term is listed.

Why is P21 giving me this message?

I have uploaded my SDTMs to P21 and created the define file.      In the SDTM issues I am getting a warning that VSTESTCD value not found in Vital signs Text Code extensible codelist.   

Here is what it lists:

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).