SDTM

I'm working on TS domain for study. I see confusing guidance from CDISC definitions for ACTSUB and SSTDTC

SSTDTC: The earliest date of informed consent among any subject (Date/Time of Informed Consent, RFICDTC) that enrolled in the study. For studies conducted without informed consent (ie. emergency use) use the date of treatment. Dates for subjects who were screen failures are not included.

ACTSUB: Actual number of subjects enrolled; may include subjects who were not randomized.

In your blog about new features for SEND validation rules you state that

Does the Pinnacle 21 use the Codetable Mapping Files issued by CDISC? If not, do you have any plan to use them in future?
Yes, we do check data at the value-level and so we use codetables that are similar to CDISC.

Is that also the case for SDTM and if so which rule applies CT2005?

Hello,

The rule SD1331 is absent in the last FDA Validator Rules 1.3 Release. However it present as in P21 Community as well as in Enterprise version of Pinnacle 21, as well as here on this web site.

Could anyone explain the situation please.

Thank you in advance.

Serhii

Hi!

I have AESTDTC that has date and timepart, and the check fires if the datepart of AESTDTC is the same as datepart of DSSTDTC. Could this be updated to check only datepart in this case?

I am currently using P21C both v3.0.2 and v2.1.3 whose engines are legacy PMDA.

When I run P21 checks to SDTM with CT version 2012-12-21, 2018-12-21 respectively with P21C v3.0.2 and v2.1.3,

I have seen huge gaps in each results.

Here's a summary of number of errors from our SDTM packages.

Hi,

I recently noticed few rules has changed from NA to Error/Warnings in Pinnacle 21 Enterprise Validation Report. Example SD1229 - Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. How we can populate xxORRES variable when its a NOT DONE record?

Thanks

Abin

Hi, I have a question about sensitivity analysis in SDTM.

After database lock, without unlock process, we want to modify SDTM using hard-coding in case that data is required to be unlocked.

We think sensitivity analysis will be performed based on ADaM instead of SDTM, though the modification is based on raw data.

Please suggest which data (SDTM or ADaM) reflects sensitivity analysis.

Thank you in advance. 

Hi SDTM Experts,

CEOUT produced Warning: SD1075 CG0467 Variable not recommended for use. SDTM IG has example where CE.CEOUT (example #4 under FA section). Also, per SDTM v1.5, --OUT are acceptable in Events Observation Class.
Could you please shed some light if this check is not applicable to CE?

Thank you in advance.

Hi, 

This is Manabu.

When I executed P21 community version 3.0.2 engine 1511.6 with IG 3.1.3 PMDA configuration, SD0058 message was shown.

When I executed P21 community version 2.1.3 with IG 3.1.3 PMDA configuration, this message was not shown.
I'd like to know how to manage this message.

Best regards,

Manabu

Dear Team,

Could you let us know when will the P21 Community Version for SDTMIG v3.3 be released?

Thanks

Umaporn