SDTM

Hi

For the dose escalation studies i.e for the same drug different dose levels for different coherts, how the arms should be assigned.

Should we consider as only one arm, or else each dose level should be treated as separate arm.

And how would be the elements.

Dear all,

In a study tratment administered day is taken as DAY 0. And rest of the days are DAY 1, DAY 2....etc. Please helm me how to calculate the actual study day in this case.

When validating SDTM and inlcuding define.XML, should we expect warning to go away regarding values not being in extensible codelists?  I've confirmed that the define does inlcude all unit codes in the sdtm data.  Its true that the value is not technically in the extensible codelist (as provided by CT docs), but it is the define.xml so I was just wondering how the FDA would know that the extensible codelist has in fact been "extended" in the define.XML.  This applies to any CT2002 warning.

Thanks!  Amy

Should the issues with severity of "Warning" be included in the SDRG?  Or just those with a severity of "Error"?

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