SDTM

Hi,

Is there any plan to release September CT for Pinnacle version 2.2.0 & 2.1.3? The latest available CT for the download is June CT;2019-06-08

Thanks,

Ravish

Hi Team,

While trying to validate SDTM datasets along with define.xml using Pinnacle 21 Community version, why do we get the Error message as Value for SCTESTCD not found in (Causality) user-defined codelist even if the values are added to the Codelist tab in the metadata and define? This message is appearing for multiple scenarios.Is there any specific information that needs to be updated in the Pinnacle 21 metadata spec to avoid this error?

Based on section 4.1.5.3.2 of SDTM Ig, if the variable value is greater than 200 characters, we place the first 200 characters in standard domain and rest in supplemental qualifier domain. The QNAM will have prefix 1,2 ... but the QLABEL stays the same. The example given also has QLABEL same for MHTERM1 and MHTERM2. However the Pinnacle gives the warning  "Inconsistent value for QNAM within QLABEL"

We have recently mapped Pharmacogenomic data to PF domain, when validating the data we get error SD0058: Variable appears in dataset, but is not in SDTM model, although, the variables PFGENTYP and PFGENRI are part of PF according to CDISC implementation guide for Pharmacogenomics and Pharmacogenetics.

Hi Team,

How should we present Country specific Inclusion and Exclusion criteria in TI dataset? As per protocol most crieria matches except few. How should those be differentiated? Can we use IESCAT to mention the country ?

Hi Team,

Why do we get an error for SDTM/dataset variable label mismatch for IETESTCD variable when validated through Pinnacle? The variable Label assigned is per SDTM IG as below:

Incl/Excl Criterion Short Name

Please suggest.

Dear Team,

Is it advisable to submit a study to FDA without EX domain in case of an observational study? 

This study comprises of deceased subjects where the contrast agents provided to them is being monitored or analysed. Hence this detail is captured in the AG domain.

Also, i would like to know the list of Mandatory domains for SDTM submission.

Regards,

Bharath, V

Dear colleagues,

Could you please help to map following eCRF pages: Subject HLA Evaluation, Sibling Donor Evaluation, Unrelated Matched Donor Evaluation? What should be the domains for them?

Thank you!

In RP domain, for RPTESTCD , we need to use RPTESTCD codelist... as this codelist is extensible, we can add our own CTs... In current mapping we've MUCUS as RP TESTCD...I found that though MUCUS is not part of standard RPTESTCD codelist, I found there is a CDISC submission value of "MUCUS" for Specimen Type codelist

can we still use MUCUS as RPTESTCD?

We are getting the CT2002 issue reported on LB records with an original unit of x10^3/ul which is not in the code list, nor is there an obvious duplicate.  There is the synonym of 10^9/L but this is not the reported unit and converting seems less "appealing" than explaining. 

What would you suggest the cDRG explanation be for this scenario?