SDTM

Description

Technical support questions about SDTM standard and validation rules

Device domains for human clinical studies

May 23, 2018
Forums

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

QS domain - logically skipped items in C-SSRS

May 21, 2018
Forums

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.

Define ARM with RUN-IN design

April 30, 2018
Forums

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.

SD0064

March 19, 2018
Forums

Below Error is from v2.2.0 P21 report. Seems like usubjid are identical in DM and other dataset. Any particular reason?

 

USUBJID, SUB:SITEID    XXXX-XXXXX, null    SD0064    FDAC040    Subject is not present in DM domain

SD0006: No baseline result in EG for subject warning is present when P21 report is executed on SDTM datasets only and missing for SDTM+Define

March 19, 2018
Forums

Hi,

I am getting SD0006 WARNING during Pinnacle21 v2.2.0 execution on SDTM datasets. But, this warning is missing when I add define with SDTM datasets during execution. Any particular reason. No change in data.

Thanks

Ajay

SD0005

March 18, 2018
Forums

According to the SDTM IG for Medical Devises V1.0, DISEQ should be unique within a parameter within a device (SPDEVID) within dataset for DI domain, but for other domains, --SEQ should be unique within every subject/device combination within dataset.

Why does SD0005 always fire when SPDEVID is not unique wuithin a device, but unique within every subject/device combination?

SVSTDTC > SVENDTC..no warning/Error shown in Pinnacle report

March 15, 2018
Forums

In one of study, I have scheduled visits such as SCR, P1, P2, EOS/ET.

(SVSTDTC & SVENDTC) at EOS/ET visit      <        (SVSTDTC & SVENDTC) at P2 visit which is not an ideal case however Pinnacle 21 didn't catch this as warning/error in report.

I am using SDTM v3.2 along with Pinnacle v2.2. Are there any way to handle this type of scenario?

Kindly guide me on this situation.

Thank you!

Two different QSTESTCD for the same questionnaire ?

February 26, 2018
Forums

Hi all,

I dont quite get why we have 2 different TESTCD for the same questionnaire. For example, The Overactive Bladder Questionnaire: OABQ0116 and OABQ0213 are used for 'Decrease Physical Activities'. I see that one is short form and one is not, but from what i see they are the same. It still doesnt make any senses to me.

 

Thanks,

Yen