SDTM

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

Hi,

I believe that the community version 2.2 has a false-negative alert of EC domain. The report for SDTM v 3.2 stated that DOMAIN(=EC) value not found in extensible code list.

Thanks,

Verna

Dear all,

If a subject can be re-screened up to 4 times, then this same subject should be listed 4 times in SDTM with 4 different subject numbers. Does it make sense to include the previous screening number of this subject into SUPPDM? I am not able to find any hint in regards to this in the SDTMIG. Thus, this subject can be traced back to the first screening number...?

Thanks for your help in advance!

Manolya

Hello,

CT2001 check generating Error for SUSTRTPT value not found in 'Relation to Reference Period (STRTPT)' non-extensible code list. But according to IG 3.2 SUSTRTPT follows (STENRF) terminology code list. 

CT2001 check need to update for SUSTRTPT and SUENRTPT.

Thanks

Saurabh

Why is there still a check for the AETRTEM flag in SUPPAE when there is no longer a mention of this variable in the FDA Study Data Technical Conformance Guide (most recently July 2016)?  Thank you, Monica Massaro