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

h Harshal

on 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!

Forums: SDTM

s Sergiy

on March 15, 2018

How to automatically identify an order of study visits?

Hi Harshal,

This check is not implemented yet. We do not know how to automatically identify an order of study visits. For example, "EOS/ET" is not a standard value for the end of the study visit.

Some additional guidance and formal requirements for SV domain from FDA, PMDA or CDISC can simplify this case. For example, if records in SV domain are pre-sorted in expected chronological order, then an automated validation can be possible.

Kind Regards,

Sergiy

h Harshal

on March 16, 2018

Thank you Sergiy!…

Thank you Sergiy!

I agree with explanation provided by you. Any suggestion to handle this kind of situation with any method/technique or we need rely on SAS programming.

j Jozef

on March 17, 2018

Check on order of visit

Hi Harshal,
If the visits are correctly defined in TV, this is a rule that can easily be added without SAS programming needed.
You can contact me for more details.
Jozef