SDTM

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

Hi,

We got SD1339, "Missing EPOCH value, when a start or observation date is provided", firing in a DV domain where DVDTC is populated (date when the deviation was reported), but DVSTDTC/DVENDTC are missing (dates when the deviation occurred). Per SDTM-IG, EPOCH in DV is the "Epoch associated with the start date/time of the deviation". It should therefore not be tested against DVDTC.

Kind regards,
-- Thierry

We got SD2239 firing (different --TPT for the same --DTC) for SDTM-IG 3.2, FDA flavor. It references CG0240, but the latter is about one-to-one relationship between --TPTNUM and --TPT, and does not mention --DTC. Furthermore, since --TPT is a planned timepoint, so it makes no sense to compare it with an actual datetime. (You could have two samples drawn on the same date/time, but which were planned to be taken on different timepoints, for instance.) Apparently this is a PMDA rule, but it is present as FDA rule as well?

Hi all

I have FATESTCD='OCCUR' and FATEST='Occurrence' in my FA domain and this produces no Pinnacle 21 error, however when I run my Define.xml through Pinnacle it produces the following: 'FATESTCD/FATEST mismatch in Codelist 'FATESTCD'

The note on the rule says: 'When SDTM Event or Intervention qualifier variable is used as FATESTCD, then FATEST should be the corresponding qualifier variable label.'

Can some advise, what should FATESTCD/FATEST be for this, should SDTM change or just the Define, and if just Define what should change ?

Best

Colm