SDTM

Hi,

 

I have the case where I have a LBTESTCD = HCG and LBTEST = Pregnancy Test. HCG is part of CT, but Pregnancy Test cannot be found in LBTEST codelist. There is also no other similar value. Therefore, I get this error message. Did someone have the same issue. If so, please let me know. Are such cases considered for future`update of SDTMIG?

Furthermore, what is the difference between the validation checks CT0082 and CT0082R. They seem to be the same...

Best regards,

Manolya

Hi,

I have populated DSDTC and DSSTDTC and only included DSSTDY. Do I really need DSDY in the dataset also? If so, why is it not in the SDTMIG?

Best regards

For TR, it needs to take into account the TRLNKID before deciding its a duplicate.

Dear Sergiy,

Thanks a lot for the new release.

Hi All,

The check SD0040 only checks for inconsistent test names against same test code. Does it also check if 2 different testcodes use the same Test name?

Hi All,

I would like to know which domain would be suitable for "Polysomnography (PSG)" and "Evoked Potentials" forms. I can see in SDTM IG Page 281 that "SL" domain is reserved for Sleep (Polysomnography) Data however it is still under discussion.

So, in this case, which domain would be suitable for this data?

 

Should I map it to FA domain?

Is check SD0065 a bi-directional check? Does it check the presence of USUBJID, VISIT, VIISTNUM combination match between other domains and SV both the ways? To be precise, if a VISIT/VISITNUM combination exists in SDTM domains and does not exist in SV, it flags a warning message in the report. Does it hold true for the other way round too? If there exists a visit in SV but is not there in any other domain will it mark this as a warning too? This case is particularly for Screen Failure subjects.

Hi There, For our new study we are following 3.1.3 SDTM implementation. We are validating the domains with 1.4 validator against 3.1.3. I observe few issues as specified below along with variable length warning/error messages which we took care by creating a macro to assign the exact length based on highest length of the observations at the end. 1. I am getting a constant warning message of 'FDA Expected variable not found' for EPOCH in many domains. Is it mandatory to include EPOCH in all those domains?

Hi,

A sponsor and collaborating CRO has this domain included. The Associated Persons standard under development is really part of Model 1.3/1.4 of SDTM, but nonetheless it ends up in our database.  Since it is new, it makes sense that the current validators through OpenCDISC 1.4 would not have the validation rules implemented yet for this dataset, and would give a message like "Class Unknown" and reason "Configuration Missing".