SDTM

Hi Folks,

When I use the validator, I get a message that the number in my STRESN variable is not the same as STRESC variable. I have checked the .XPT and the values are exactly the same.  Here is what the validator spits out

PPSTRESC=165.163206499472, PPSTRESN=165.1632065

I get this message only for 3 such observations rest of the observations match. I am using SDTM-IG 3.4 (FDA) configuration.

Thanks for your help.

Regards,

Milan

Dear, we encounter a P21 issue like this 

SD2287: Missing ONGOSIND Trial Summary Parameter and 

SD2244: Invalid TSVCDREF value for FCNTRY ISO 3166

May I know how to deal with it?

Need some guidance on mapping data for newborns/neonates.

Study Details:

- Enrolls only pregnant participants

- Includes seprate CRF pages collecting data on neonates/newborns 

- Separate unique subject numbers assigned to neonates

Hi, consider me as an absolute beginner to this. I am trying to validate using SDTM through cli but getting an error. I have tried the exact file using the GUI and it has generated me the report. Details are below.

Engine
FDA (2304.3)

Standard
SDTM

Source Format
SAS® Transport (XPORT)

Configuration
SDTM-IG 3.2 (FDA)

Source Data

Define.xml

I have checked the latest SDTM Terminology 2024-03-29 for codelist "Trial Phase Response" (codelist code is C66737), and this codelist indeed have a submission value of "NOT APPLICABLE" with code of C48660 as you can see from the attached screenshot.

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.