SDTM

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!

I am getting an error "Invalid referenced record" for SUPPQS domain. However all SUPPQS observation have valid reference record in QS domain.  The explanation for SD0077 states- 

"Reference record defined by Related Domain Abbreviation (RDOMAIN), Unique Subject Identifier (USUBJID), Identifying Variable (IDVAR) and Identifying Variable Value (IDVARVAL) must exist in the target Domain."

Additional Info: IDVAR is not QSSEQ, but it is "QSGRPID". Does this have any effect for the above issue?.

Hi,

We are getting SD0080 warning when  Disposition date is 13MAR2018 and AE start date is 2018.

I was wondering how P21 handle the partial date in this case. Is it considering 2018 as 31DEC2018?

We had also tested with AE start date=2017 and the warning was not present.

Any guidance will be helpful here.

 

Thanks

Ajay Gupta

 

The last CDISC Coded Terminology file was released on June dated 2018-06-29. As its a quarterly release and there were no CT file released on September from Pinnacle. The CT file for September 2018 have been published for MSA and updated terminologies in MSA are not available in Pinnacle as a result.

 

Please tell when the CT file for the month of September will be published?

Hi,

 

I am getting an error "Invalid referenced record" for SUPPQS domain. However all SUPPQS observation have valid reference record in QS domain.  The explanation for SD0077 states- 

"Reference record defined by Related Domain Abbreviation (RDOMAIN), Unique Subject Identifier (USUBJID), Identifying Variable (IDVAR) and Identifying Variable Value (IDVARVAL) must exist in the target Domain."

Pinnacle output excel report is throwing below warning when as per SDTM IG 3.1.3 its not recommended to derive EPOCH for SV domain?

Source    Pinnacle 21 ID      Publisher ID        Message                                                       Severity

SV            SD1077               FDAC021       FDA Expected variable EPOCH not found       Warning

 

 

Hi,

When TSPARMCD is "PCLAS" in TS domain, I set "Protein Kinase Inhibitors" for TSVAL and "N0000175076" for TSVALCD.

I ran the P21 Community v2.1.3 with "SDTM_3.2_PMDA" config and ran the P21 Community v2.2.0 with "SDTM_3.2" config, then I found SD2263 and SD2265 were not fired in only P21 Community v2.1.3 with "SDTM_3.2_PMDA".

Does anyone know why SD2263 and SD2265 were not fired in this version ?

Note:

Latest version of NDF-RT in P21 Community v2.1.3 is "2016-07-05"

Latest version of NDF-RT in P21 Community v2.2.0 is "2016-09-06"