SDTM

Why Severity info is no longer available on the P21 community version?

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?

Thanks.

Hi

I am not sure why this issue fires if all looks okay for PCLAS where TSVAL = POTASSIUM CHLORIDE, TSVALCD = N0000145835. As per NDF-RT all is okay. The version is 2018-02-05 Any ideas? I have seen similar issues for values that are uppercase especially.

Pinnacle 21 Community Validator raises a rule SD0072 error "Related Domain Abbreviation (RDOMAIN) must have a valid value of Domains included in the study data".  

I am following the Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review use of FACE as a domain. I am also following the SDTM Vaccine TAUG v1.1, which explicitly provides an example where RDOMAIN='FACE'. A dataset face.xpt exists with DOMAIN='FACE'.

Is there anything I can do to avoid the SD0072 error and still comply with the OVRR and Vaccine TAUG guidance?

Hello,

This question is regarding the validation rules in SDTMIG v3.3. After using community 3.1 to check DS dataset, rule SD1315 'DSDECOD is not the same as DSTERM, when DSCAT='PROTOCOL MILESTONE' fired.

But according to CDISC conformance rule, this rule is deprecated in v3.3. Can you please check it?

Thanks.

This check is firing because our CMDOSTXT is unknown, and it is populated with "UNK". Now my question is if it is valid to populate CMDOSTXT = UNK or UNKNOWN. If so, the check does not need to fire in this case, right?

Hi,

We currently have a scenario where the drug is dispensed to the subject for a period which patient will log in the diary and will be entered in the database during the next onsite visit.

- Planned Dose on CRF = 1 tablet every day

- Actual Dose on CRF is aggregate of drug intake during entire period of 1 month = 30 TABLETS (1 Tablet= 10 mg (protocol specified unit))

Hi,

Hi, 

I have a question about SDTM DM ARMCD and ARM data about below case:

The subject was mistakenly randomized but not treated study drug. And, the subject's data has been changed to  "No(screening failure)" from "Yes(screening pass)" on screening pass yes/no page.

Then, according to the 2020 Nov FDA TCG, if randomized subject and not treated study drug, is ARM and ARMCD assigned corresponding to the random id? Otherwise, should the ARM, ARMCD be assigned as Screen Failure, SCRNFAIL?

Hi Team,

I was trying to generate P21 specification template for 3.3 IG.

I couldnt find define for version 3.3 under configs-> 1907.2

Could you let me know if it is available - if yes where can I find it :)

Thank you,
Samhitha