SDTM

Hi all,

     In the LB and VS domains, I'm getting SD2239 (Inconsistent value for -TPT).  I believe it's due to including a code multiple times on the same visit but not having time populated in the -DTC column.  I have specified unique -TPT and -TPTNUM.

Is there an additional variable to add or a way to modify the key in the Define.xml that might remove the issue?  

Brian

Hello Everyone,

I have noticed a discrepancy in the P21 Community version regarding the validation of dataset and variable labels. Specifically, when validating SDTM datasets, these labels are not validated. However, they are validated when the Define.XML is validated.

I'm unsure why this inconsistency occurs, and I would like to know if anyone else has encountered this issue and how it has been resolved.

Thank you for your assistance.

While validating datasets along with a define of 2.1, the validation report is not identifying the classes of custom domains as well as supplemental qualifier domains. Whereas if I run the validator with a define of 2.0 or without define it identifies the class. I am having a question as to whether it's some data that I am not providing in my define 2.1.xml that is causing this or shouldn't it identify regardless since its identifying without define present.

Why RFSTDTC, RFXTSDTC, RFENDTC, RFXENDTC, RFICDTC & RFPENDTC are called as record qualifiers in DM dataset, whereas --STDTC variables in other domains are called as timing variables ?

Hi all,

I found that when performing dataset validation alone, a variable label mismatch with the label defined in the configs does not trigger an error in the validation report. However, when performing validation that includes the Define-XML, the DD0136 error is triggered.

Hi, I have a question about 'REGID' TSVCDREF.

EudraCT number has been replaced by EU CT numbers since Feb 2023.

But, "Values for TSVAL when TSPARMCD = "REGID" (Registry Identifier) will be identifiers assigned by the registry (e.g., ClinicalTrials.gov, EudraCT)." is in SDTM IG V3.4.

If study started after Feb 2023 and has an EU CT number, what value will be described in TSVCDREF? EudraCT (depending on SDTM IG example) or EU CT (replaced value) ?

Thank you in advance.

Hi, I am creating domains based on SDTMIG v3.3. Since Hepatitis C Virus Antibody (HCAB) has been removed from MBTEST (MBTESTCD) in the latest CT (version date 2023-12-15), with the reason for its removal being that in SDTMIG v3.4, antibody tests will be represented by the IS domain, this leads to a CT2002 issue during validation. Consequently, I would like to ask for advice on whether I should use the latest version of CT for validation and document this issue to the reviewer's guide, or use the previous version, which is more suitable for SDTMIG v3.3?

Kind regards,

John

Can we have partial dates in DM.RFPENDTC?

When reporting aCRF page numbers in the Define, should the page numbers be the PDF page numbers or the page numbers printed on the aCRF?

When creating the VLM for a domain (LB for example), to what extent do we need to report multiple origins for variables? To specify, say SUBJID, LBORRES, LBORRESU, LBMETHOD, LBDTC are all collected on the CRF and in an external for multiple LBTESTCDs. Do we need to create a row in the VLM for each variable, in relation to each LBTESTCD for each Origin, or is there a simpler way to report the multiple Origins for each variable without having to create a row in the VLM for each variable for each LBTESTCD from each source?