SDTM

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"

My baseline value for analysis is an average. The average is not collected on the CRF. In my SDTM dataset, should I

1 - label all records taken to compute the average with --BLFL = Y.

OR

2 - derive the average as a separate record and label only this one with --BLFL = Y and --DRVFL = Y.

I have the feeling that option 2 is better. I also have to calculate averages at the different time points and having a record derived for each of these averages appears to make life easier for a reviewer.

I have submitted a test submission of SDTM data to the FDA for a study.  The FDA has responded with comments.  They also ran their own Pinnacle 21 validator report against the data.   The Pinnacle 21 report that the FDA ran contained more items/issues than I came up with; they had errors that hadn't appeared in my report(perhaps due to the way it was configured).   With that said, there were no REJECTS in the Pinnacle report, and the submission did not fail the Technical Rejection Criteria.   Can the ERRORS that now appear in the FDA report, can they just be explained in the SDRG and the SD

Hi, I've two versions of the protocols in my study where one of new the exclusion criteria was added in the last version of protocol. All other Exclusion criteria were exactly same except for the new addition in the last protocol.

When will the Controlled Terminology files for 2018-06-29 be available on the webpage https://www.pinnacle21.com/downloads/cdisc-terminology ?

Thanks in advance!

-Snehal