SDTM

Hi,

When we're using NMPA Engine, there are lots of issues related to NY value in Chinese in P21 report, such as SD1253 (DTHFL ≠ Y).

This is because in datasets, we use 是 for Y and 否 for N.

Can P21 add recognization for 是/否 value in the rules of NMPA? I believe this will help a lot.

And another question here, for the issue of SD1023, what is the Chinese value of unplanned VISIT/VIITNUM to be recognized in P21?

Looking forward to your reply!

Best Regards,

YY

As per Validation Rule SD0063 SDTM variable label not validating with the IG when we are validating through SDTMIG 3.3 or 3.4, Is there any planning to apply this validation rule for IG 3.3 & 3.4 in upcoming engine?

We have many problems with the (new?) version 2405.2 ...

For example, we get many (sometimes thousands) of errors "LBSTRESC value not found in 'Laboratory Test Standard Character Result' extensible codelist" when the value represents a number (LBSTRESC is "char").
These are clearly false positives.

I am getting below mentioned issue related to the model permissible Reference Range variables i have added in Vital sign domain but the label for the variable is going correct. how to resolve this issue are there any other labels present 
 

Long CMDECOD text is correctly being split into CMDECOD, CMDECOD1, etc., as specified in the SDTMIG.  The problem is that these split CMDECOD values are being flagged as not appearing in the WHODrug dictionary.  From this end, it appears that P21 is only checking CMDECOD itself against the contents of the WHODrug dictionary, so looking at just the first 200 characters, without concatenating the values found in the additional segments.  Is that the case, and if so, is there a workaround for it besides manually confirming the full term appears in the dictionary, and then documenti

We have observed that engine FDA 2304.3 and engine PMDA 2311.0 have updated the variable labels for COVAL1-COVAL10 and TSVAL1-TSVAL10. Currently, these labels are aligned with those of COVAL and TSVAL, which appears to be in accordance with the guidelines in SDTM IG3.3, specifically section 4.5.3.2 . These guidelines apply to datasets such as CO, TS, TI, TE, IE, and SUPP.

However, when modifying based on QLABEL, we are still encountering the error: "Inconsistent value for QNAM within QLABEL."

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