SDTM

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
 

Good day,

Is there an estimated timeframe as to when validation files for terminology package 2020-09-25 will be available for P21 2.2.0 and 2.1.3?

Thank you!

Kind Regards,

Daniel Rolo

Good day,

I would like to enquire as to when validation rules for the SDTM IG v3.3 standard will be available in P21 Community? With FDA support starting in March 2021, the need to validate fully against this IG would increase in the coming months. Thank you!

Regards,

Daniel

Hi,

We are using the clients P21E to validate our SDTM datasets. Our QA team is requesting that we delete the SDTM dataset after we run P21E report so that the client will not have access to the prevalidated SDTM dataset and instead wait for the official SDTM package that we will deliver. Is this possible in P21E?  Can the client access the actual SDTM datasets if we dont do anything after running the report?

Hi,

Raw float results in a study are sometimes entered has .5 instead of 0.5, for example, in EDC. Why Pinnacle is giving an issue for that? Is it because Pinnacle is expecting to see 0.5? I though --ORRES variable should contains original raw result.