SDTM

When validating, I get CT2002 "Variable value not found in extensible codelist" for a questionnaire I have used in previous studies and which I am planning to use in future studies. I cannot find a corresponding QSCAT variable value in the CT so I am looking to have it added. I believe the correct way to add a new term to the CDISC controlled terminology would be to make a request through the NCI at https://ncitermform.nci.nih.gov/ncitermform/. Could you please confirm?

Hi,

In SDTM PC, I have PCSTRESU unit "ng/mL". "ng/mL" is standard PK Units of Measure C67306. I am getting warning for CT2002 rule, because "ng/mL" is part of "PK Units of Measure" not "Unit".

Is there any way to resolve this warning?

Thanks,

Saurabh

Pinnacle21 Community reports show SD1077 (FDA expected variable not found) as a "Warning".  The Enterprise Validation Report shows SD1077 as an "Error" in the FDA column.  

The validation rules on the website also show SD1077 as a Warning: https://www.pinnacle21.net/validation-rules/sdtm. 

I'm getting this error because Epoch is not included in SV. The study is following version 3.1.3 of SDTM.

I wanted to confirm that this is now considered an "Error" for purposes of the SDRG.  Or would this be considered a "False Positive"?

Thanks

Hi, I found the term and code in the NDF-RT dictionary, but I am still getting errors in Pinnacle 21. Is the dictionary up to date?

TSVAL=Antibodies, Monoclonal and TSVALCD=N0000011174. Does anyone know why I am still getting errors in the Pinnacle 21 report?

Thanks.

Hi!

I am confused with the order of the EPOCH variable in SV. It comes after VISIT and before SVSTDTC. As per SDTM Model this is the correct order, however, I still get a Pinnacle21 message : SD1079 / FDAC035

Best regards

Manolya

Hi,

We have protocol that is split into multiple parts/studies - we are debating if we should create SDTM/ADaM separate for each part or combine them - We expect it to be under one SAP, CSR. Are there any FDA requirements for these and any recommendation/expereince of one approach vs the other.

Thanks

Deepika

When validating my SDTM datasets I was already surprised that for the CT the validator presents me the choice "2016-03-27" whereas there is no such version on the NCI server: there is only a version "2016-03-25" and a version "2015-03-27".

I am creating FACE domain, I get a warning that FDA expected EPOCH variable is absent. When I added it, I kept this column far right in the dataset as there is no EPOCH variable mentioned in IG under FA. Now when I have added it, I got another warning regarding variable order is incorrect. I also have FAORNRHI variable which we would need to submit for which i have similar warning.

Could you please suggest what should be location of EPOCH & FAORNRHI in FA domain.

Thanks in Advance.

SD0062 is defined as the "Reject" by PMDA, but it is the "Error" in P21C.

Is this a bug?

Regards,

Takayuki

My understanding is that the compliance tool do not process the AP domains.

Do you have an estimated timeline? Is that in the plans?

Thank you in Advance

Best Regards

Jacques Lanoue

Associate Dir, Reporting Data Standards

Novartis Pharmaceuticals Corporation

One Health Plaza

East Hanover, NJ 07936-1080

USA