SDTM

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

This topic was already discussed in the SEND Forum in 2015, but there is no change till today. SD0007 is still an error. It fires for the DA dataset, if subjects are dispensed both tablets and capsule at the same visit. In this case there are two records per visit with DATESTCD= DISPAMT, but DASTRESU is TABLET and CAPSULE. In a "double blind / double dummy trial" tablet and capsule can be both: study medication or placebo. Therefore a specification via DACAT is not possible.

Hi,

Got a SUPPAE with the QNAM/QLABEL = AETRTEM /TREATMENT EMERGENT FLAG but the P21 validation rule says 'No Treatment Emergent info for Adverse Event'.

Why does my validation report have hits on this rule?

br Kirsten

I have downloaded the SDTM terminology from your website: https://www.pinnacle21.com/downloads/cdisc-terminology (latest 2018-03-30) and noticed that RACE codelist has

       <CodeList OID="CL.C74457.RACE" Name="Race" DataType="text" nciodm:CodeListExtensible="Yes">

but in NCI RACE is specified as

       <CodeList OID="CL.C74457.RACE" Name="Race" DataType="text" nciodm:ExtCodeID="C74457" nciodm:CodeListExtensible="No">

It is also the case for other versions.

Can I include device domains DI and DU with human clinical trial SDTM submission? My study captures some device information related to CT imaging.

I tried to include this in the submission package, but I got a "Dataset class not recognized" for DI. (DI is defined as special purpose domain in SDTM IG for medical devices)

DU was accepted as custom Findings domain

Thanks,

Saravanan

Hi, In recent TCG v4.0 and 4.1, FDA has guidance to map logically skipped items in QS domain. My company collected Coulmbia Suicide Rating Scale (C-SSRS) and there are Describe questions which are typically blank based on response for previous Y/N question. We haven't mapped this in the past, but looks like FDA guidance is to map these. Has anyone does this and any thoughts/issues doing it.

Thanks.

Hello!

I have a special study design and I need you advice. The study has a screening, then all subjects start to take drug A during the Run-in period. Then, before randomization, subjects are tested for a randomization criterion.

If they fail, the subjects do a special visit Run-in early termination (only for them) and are discontinued.

If they passed, they are randomized to A+B or A+C and they continue the study. The 2 study treatments to be compared are B and C.