SD1117 rule for duplicate records of PK parameters calculated per study period

Sergiy

on March 8, 2022

P21

Hi John, In general, both…

Hi John,

In general, both PPGRPID and PPCAT variables are not designed to capture Timing information. 

Kind Regards,
Sergiy

Hi Sergiy,   So the…

Hi Sergiy,

So the solution is to add the timing information to SUPPPP and provide an explanation in the reviewer guide?

However, in SDTMIG v3.3, the Day information for the parameters calculated for Day 1 and 14 was added to the PPGRPID.

Kind regards,

John

Sergiy

on March 9, 2022

P21

I would use PPTPT variable. …

I would use PPTPT variable. --GRPID is designed for grouping records. Grouping of all records for Period 1 is OK! But utilization of --GRPID variable as primary timing information may be not a good practice.

Another alternative could be VISIT variable.

Many thanks for your…

Many thanks for your suggestion! My case is more like grouping the records by period.

The PK sampling was drawn on Day 1 and Day 2 in each period with TV.VISIT=PERIOD x DAY 1 or PERIOD x DAY 2, but the PK parameters were calculated per Period.

Should we define new TV.VISIT for this case? PPTPT may be a solution, but it would be a little overlapping with the TV.VISIT.

SD1117 rule for duplicate records of PK parameters

This is an interesting discussion!
First of all, NEVER, NEVER start changing your data (or where you put them) just to avoid validation errors (like SD1117) when you are sure that there is no violation of the SDTM standard. Much better is to document false positives in the SDRG.
Rule SD1117 does not say anything about PPGRPID or any -GRPID, so the messages you get must be considered as false positives, except of course when there is another underlying cause.
Furthermore, -GRPID can be anything, so there cannot be any rules on it. If you look in the by CDISC published validation rules (for 3.4 for example), there is not a single rule about -GRPID either.
Another discussion is of course about best practices, but validation rules should not enforce one best practice or another. That can be done e.g. on the company level, by adding additional company-internal rules.

Thanks, Jozef, and sorry I…

Thanks, Jozef, and sorry I didn't make it clear enough.

I'm seeking a solution to fix the problem about duplicate records caused by calculating PK parameters for multiple dosing periods, becuase the Key variables, PPCAT and PPSCAT, have been defined as the "Analyte" and "Method type" of the paramters in the SDTM IG.

According to the example from SDTM IG, I tried the variable PPGRPID for the period information but the error is still fired; the reason is PPGRPID is not a key variable to identify the unique record, abivously.

I will leave this error message to cSDRG and explan it.

SD1117 rule for duplicate records of PK parameters

Hi John,
Essentially, it is YOU who defines what the key variables for record uniqueness are, using the "KeySequence" attributes in the define.xml.
But I don't know whether SD1117 uses this. I think it only uses the surrogate key (i.e. derived in a post-processing step) --SEQ variable.