Technical support questions about SDTM standard and validation rules


March 19, 2018

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


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.




March 18, 2018

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 > warning/Error shown in Pinnacle report

March 15, 2018

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

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.




FDAC341 (Variable value not found in extensible codelist)

November 30, 2017

"FDAC341 (Variable value not found in extensible codelist)" check is not being performed unless a define.xml is loaded. Is there a reason for that? It can theoretically be done without a sponsor define.xml e.g. EGTEST has the CT of EGTEST specified in SDTM 3.2 and hence EGTEST codelist can be used to do this check.

It is a useful check to have prior to generation of define.xml since it would catch the problems earlier.