SDTM

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?

Hi Siergy,

We are getting “Invalid dataset name for split domain” - ERROR  which is expected as we are using FA stand alone and FACE datasets.

Seems it is expecting FAxx instead FA, however in real case it is not possible.

Even in my previous company we have the same issue where we are using FACE FAMH FAAE FACM and FA as stand alone.

The time window for the screening visits is defined as study days [-60 - -1] in the protocol. However, there are some procedures that occurred before day -60 and/or before informed consent but these observations have visit=’Screening’ in raw data. Are we allowed to derive such visits as Pre-screening in SDTM?

We used 2017-06-30 CT for a study and we wanted to validate data using pinnacle 3.0.

As it is mentioned in another link pinnacle 3.0 doesnt support CT 2017-06-30, should I not use pinnacle 3.0 and stick with the older version of pinnacle?

We wanted to follow ADAM IG 1.1, reason why we wanted to use pinnacle 3.0 for both SDTM's and ADAM's.

Please suggest!

https://www.pinnacle21.com/downloads/cdisc-terminology

Hello all,

I wonder which domain and variable to map Cycle number for a oncology trials. Or it should be not submitted.

Thank you.