SDTM

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:

Either rule FDAC047/SD0086 "SUPPQUAL duplicate records" is wrong or I misunderstand the first part of it stating "All SUPPQUAL Domains records are associated with a single parent record". There are so many examples (also in the SDTM-IG) where one SUPPxx record has many parent records - see e.g. "Section 8.4.3 SUPP-- Examples" in the latest SDTM-IG (3.2), where e.g.:
"Example 3:

Hi,

1) Inspite of giving labels to,variables as per SDTM IG 3.2, validator giving warning of variable label mismatch. Any way to remove this warning?

2) The label of variable -STRESC in rule is not consistent accros domain. Some has "Character Results in Std Format" and some has "Character Results in Standard Format" . Any rationale?

P21 v.2.1, CDISC-CT 2015-12-18, configuration SDTM 3.1.2 (PMDA).

I got errors that "EDLEVEL" and "Education Level" are not found in non-extensible codelists SCTESTCD/SCTEST.
However, if I look into the XML distribution of CDISC-CT-2015-12-18 it says that both codelist SCTESTCD and SCTEST ARE extensible (def:Extensible="Yes")

Hi,

I am trying to upgrade from v2.0.1 to v2.1 and we only use the CLI.  Been trying to get this to run but getting errors.

I even ran the help on the CLI jar file and received the following issues.  java -jar validator-cli-2.1.0.jar -help