SDTM

Hi,

I assigned by mistake a unique sequential value (1 to 47) for each line to variable TSSEQ in TS domain. The latest version of Pinnacle 21 didn't trigger any error nor warning even though this is somehow not in line with the SDTM IG 3.2 example.

On the other hand, I wonder if it's really an error for the IG says "TSSEQ has a different value for each record for the same parameter.", which is true in my case since all lines in TS domain have a unique TSSEQ value.

Hi,

As protocol deviations presented in the DV domain hold subject level deviations, some deviations recorded in the study are Site level deviations. Additionally some are related to the site personnel and are not specific to any of the study subjects.

Hi,

I get an error when I try to use variable --REPNUM in SDTM 3.2 while running the latest version of Pinnacle 21. 

According to the "CDISC Therapeutic Area Data Standards: User Guide for QT Studies (Version 1.0 Provisional)" that was based on the SDTM 3.2 version, the variable --REPNUM was added and the guideline says: "The --REPNUM (Repetition Number) variable is a variable which has been approved by SDTM Governance but has not yet been included in a formally published version of the SDTM."

Hi,

I ran the latest version of Pinnacle 21 and got the following warning : QSMETHOD Variable not recommended for use (SD1075 or FDAC030) in QS domain.

According to the EQ-5D-5L Questionnaire SDTM Guideline V1.1, the variable QSMETHOD should be used to indicate that the VAS Score was collected using the Visual Analog Scale (0-100).

I think there should thus be an update for this check.

Thanks

Pierre

 

 

Hi,

According to the latest Study Data Technical Conformance Guide, variable EPOCH should be included in a wide selection of domains. 

Accordingly, I added EPOCH into CM domain only to have a warning saying "Variable is in wrong order within domain". I wonder on what Pinnacle 21 (by the way I used the latest version available 2.1.0) can assess that this variable is in the wrong order. I tried several different places in the domain and I always get this warning. 

Can anyone please advise which is the best fit domain to place the subject feeling (pain) information that is captured on subject dairy with the date values. Do we keep these date information into SV dataset?

 

Thanks in Advance

 

Hi, Can someone point me to some documentation that explains the xxTPT and xxDTC relationship? I understand the xxTPT/xxTPTNUM/xxTPTREF relationships, but xxTPT and xxDTC is new to me.

I have a record where xxSTRESC = 01 and xxSTRESN = 1. For another record, I have xxSTRESC = 080 and xxSTRESN = 80. I do not believe this is an issue, as I have seen data like this many times before and it’s never been flagged in previous OpenCDISC releases. When selecting the 3.1.3 FDA checks in Community 2.1.0, this is not flagged as an issue. However when I run the validation using PMDA 3.1.3 checks, SD1212 does state that this is an issue where xxSTRESN does not equal xxSTRESC. Is this an issue with the PMDA checks, or was this intentional?

When selecting the PMDA 3.1.3 checks, SD1203 is correctly flagging DADTC dates after RFPENDTC, and also correctly flagging xxDTC dates in a custom findings domain as being after RFPENDTC. However when the FDA 3.1.3 or 3.2 checks are selected, SD1203 is not showing this same issue. Also when I go to the “Rules” tab, SD1203 is not listed out. Has this check been removed from the latest Pinnacle 21 Community 2.1.0 release?

RELREC.USUBJID is an expected variable, however Pinnacle 21 Community 2.1.0 is flagging an error stating that RELREC.USUBJID is