SDTM

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).

Can it be confirmed if P21 Community v4.0.1 no longer checks labels (SD0063 and SD0063A).  If so, why?  thanks

The Controlled Terms of ETHNIC in IG is "ETHNIC", I noticed that there is a code of "ETHNICC" in the 2022-06-24 version of CDISC SDTM Controlled Terminology, can I use this code here?

I am new to this froum and woud like to know is correct way to define VLM where clause for LB domain.

Can we use WhereVarlist as SUPP.QNAM for WhereVarible from Main Domain.

Below is VLM for LBORRES , please let us know is this correct one.

WhereVarible=LBORRES;

WhereVarlist=LBVENTYP;

Comparotor=EQ;

WhereValue='LOCAL' ;

The LBVENTYP is SUPP.QNAM from SUPPLB. and LBVENTYP Orgin is CRF and eDT.

Thank you,

Ram.B

Hello, 

My question is about calculation within EDC (e.g. BMI). In Define-XML V2.1 type is "derived" and source is "sponsor". In addition should we flag these EDC calculations with DRVFL="Y" ? Or DRVFL is only populated to Y when a new record is added comparing with the source. 

Thanks for your help,

Best regards

Anne

This rule is popping up now in 4.0.0 for every SUPP domain. Even for the IDVAR and IDVARVAL for SUPPDM where SDTM IG 3.2 states: “IDVAR and IDVARVAL are null because the key variables STUDYID, RDOMAIN, and USUBJID are sufficient to identify a unique parent record in DM.”  Should we be creating a DMSEQ and setting these SUPP values? 

I noticed, when I run P21 validation, that I don't get issues if TI and TV domains are not included. Does that means that those domains are not mandatory? I always thought that we had to create TS, TA, TE, TI, and TV for a submission study.