SDTM

Description

Technical support questions about SDTM standard and validation rules

July 27, 2022

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?

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May 27, 2022

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

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May 17, 2022

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

 

 

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May 15, 2022

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? 

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April 14, 2022

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.

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April 8, 2022

Hi there,

Is there a time schedule for when Pinnacle21 plans to support SDTM IG 3.4 validation?

Thank you!

Vasyl

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March 4, 2022

Hello, I have a question regarding the SDRG completion guideline.

There is a section called 'SDTM subject domains' and it is written that 'The section provides an overview of the subject-related SDTM domains'.

 

What do they really mean by 'subject-related domains' ?So not all of the domains created will be listed there?

 

Thanks!

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March 2, 2022

Hi, I'm creating PP domain for the PK parameters calculated per study period, and I get SD1117 check from P21 report if I put the PERIOD information into PPGRPID.

I've tried to add it to PPCAT to avoid this error but it seems not a good solution because PPCAT should be populated the Analyte from PCTEST according to SDTMIG.

Is there any suggestion? Combing the PERIOD information with Analyte in PPCAT, like "Analyte: Period 1", is acceptable?

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February 26, 2022

SDTMIG 3.3 (FDA).
In my RE datasets, I have measurements for which the same device was used. So, I have more than one measurement per unique device.
Although my values of RESEQ are unique for each measurement within each subject, I get a large numbers of errors SD005 "Duplicate value for RESEQ variable".
Example:
row 1: USUBJID=21, SPDEVID=DEV33, RESEQ=1
row 2: USUBJID=21, SPDEVID=DEV33, RESEQ=2

It looks as the software wants to have SPDEVID being unique within each subject, which has nothing to do with RESEQ.

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February 23, 2022

Hello CDISC/FDA/PMDA Experts! 

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