SDTM

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!

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

I am running the P21 v2.2.0 on my SDTM datasets, and I'm wondering why I don't get the warning for FDAC022 (as I did get previously in other studies). There is no SUPPAE for this study right now, so why doesn't the warning pop up? Is it not required by the FDA anymore?

Best regards

Manolya

Hi!

"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.

Hi,

I would like to ask if somebody knows if in LB domain, is lab category (LBCAT) for Alcohol Breathalyzer Results? 

Thank you,

Konrad

In LB Domain, if the specimen is collected over a period of time, what does LBELTM refers to- Start or End of such interval?

Thanks.

Dear P21 Team,

I understand the publisher IDs for FDA currently referenced in the reports came from the FDA validator rules first released sometime back in 2014. However, these IDs have since then changed and in the latest v1.1 released in Mar 2017, they are all different to the ones stated in the report.  For example, the rule 'No Treatment Emergent info for Adverse Event' was FDAC022 but in the latest version it is FDAB001.  Are there any plans in future releases to actually align these rule IDs to the latest version? 

Thank you.

Hi,

There is a warning for DOMAIN variable value in SS data stating: DOMAIN value not found in 'SDTM Domain Abbreviation' extensible codelist.

SS domain has already been included in the 3.2 IG in findings category, but still warning appears. Is this a bug? Could you please provide further input? 

Thanks,

Abdul. 

Hi,

Is there a possibility to add a new rule that cross-checks the data in DM.ARM/ARMCD with IE? Currently, there is only a rule that checks the following:

"No records for "SCRFAIL" subject are found in IE domain" -> FDAC103, SD1033.