SDTM

Hi there,

Is there a time schedule for when Pinnacle21 plans to support SDTM IG 3.3 validation under NMPA engine?

Thank you!

zg

When I use P21 to validate sdtm data, this message "DSDECOD value not found in 'Completion/Reason for Non-Completion' extensible codelist when DSCAT == 'DISPOSITION EVENT'" occurred, because there are some DSDECOD are not controlled terminology values. but when I validated again, this message didn't occur, I'm confused, for the same data, why this message occurred some times. Anyone know it? thanks!

Hi 

I have a study with 7different arms of treatment, that mean 7 DOSE differents but  DOSFRQ and DOSU are the same.

So I have created 7 rows for DOSE with TSSEQ 1 to 7. But my question is how can I express DOSFRQ and DOSU? Should I create 7 rows each ? Or one row each? 

Thank you.

Sunset

SD1078 occurs when all permissible variables are null, but no message is generated for --DY.
Is it because --DY can be null for all records when there is no RFSTDTC value?

I am trying to create an empty excel file with all metadata from P21. Can you please advise, how to do it?

Hi, 

In the cross over study, there are two treatments, 4 periods - So  populated ARMCD as A-B-A-B. Coming to ACTARMCD - the subject is not treated for any of the periods. Example : A-B-NOTTRT-B. In this case, ACTARMCD is not match with ARMCD and getting the SD2236, SD2237 messages in the Pinnacle validation report. Please suggest, shall we consider this as false positive or any alternate solution. Also, if the subject Not treated for two periods then ACTARMCD length exceeds 20 characters [A-NOTTRT-A-NOTTRT]. Do we need to restrict length as 20 for ACTARMCD?

I have an external file of calculated SF-12 score. It cannot be added to QS because the input for that file is from SDTM QS, so adding the calculated score to QS will cause recursive programming. Is it ok if I generate a custom domain for the calculated score? I am not sure whether I can do that because this external file has the same structure as QS.  and the SDTMIG 3.2 said we can only generate a custom domain if none of the existing domain satisfy the need. 

We are using MED-RT 2022-07-05 for TSVAL/TSVALCD for PCLAS and the values are there within the dictionary but I'm still getting the following issues: 

SD2263: Invalid TSVAL value for PCLAS

SD2264: Invalid TSVALCD value for PCLAS

SD2265: TSVAL/TSVALCD value mismatch for PCLAS

TSVAL = Immunologic Agent

TSVALCD = N0000193902

Not sure why these are being flagged when I can see them within the dictionary. There were no leading or trailing spaces. I've tried with and without the parenthesis. 

Thank you in advance.

Hi,

I have  a question about the rules of SD1078:

SD1078: Permissible variable with missing value for all records.

The data of the permissible variable is collected in CRF, but all observations have a missing value, I was wondering if the variable should be remove from xpt dataset? 

Many thanks,

Simon 

Hi Everyone,

I have a question regarding generating Trial element domain for fully replicate bioequivalence studies.

In the fully replicate bioequivalence studies, After randomization, healthy subjects will take a single dose from the test product ( drug A), then after first washout period, they will take a single dose of the reference product (Drug B), then they will take single dose of test product again ( drug A). And after the third washout period they will take reference product again (Drug B). Study will be 2 Sequence design (ABAB or BABA).