SDTM

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

Which SDTM domain should be used to capture Which SDTM echocardiogram data 

Hi All,

For  the TS domain we get an error for rule ID1226 “Missing INDIC Trial Summary Parameter”.

This parameter is not required according SDTM IG 3.2.

Please refer to SDTM IG: TS – Assumptions for Trial Summary Information Dataset - point 15.

Hi all,

I'm looking for a tool that convert multiple sourced raw data to SDTM,

I have found the tool: "CDISC Express", have anyone heard about it? 

More suggestions will be welcomed!

Thanks,

Gal

Hello,

Currently dosing information collected in text form. we are unable to derive EXDOSE(numeric amount of dose) from current data. 

According to IG 3.2 EXDOSTXT: "Amount of EXTRT when non-numeric. Dosing amounts or a range of dosing information collected in text form. Example: 200-400. Not populated when EXDOSE is populated". So Dose Description mapped to EXDOSTXT variable and EXDOSE doesn't derive in SDTM EX data set.

But SD0057 rule generates warning, SDTM Expected variable EXDOSE not found.

Hello,

Is there a known issue regarding issue SD0056 appearing when running SDTM validation via the CLI in version 2.1.1?

A user has noticed that this appears when he runs a CSV report via the CLI but if he runs the report via the GUI using the same SAS XPT files then the issue does not appear.  It does not appear to make any difference which config file we use as we still get the same issue appearing.

This is the call being used: