SDTM

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

Hi all,

We are currently conducting a clinical study that collects RACE on the CRF using the following terms: CAUCASIAN, BLACK, HISPANIC/LATINO, INDIAN, ASIAN/PACIFIC ISLANDER, and OTHER.

4.1.2.9 Variable Lengths
Very large transport files have become an issue for FDA to process. One of the main contributors to the large file sizes has been sponsors using the maximum length of 200 for character variables. To help rectify this situation:
• The maximum SAS Version 5 character variable length of 200 characters should not be used unless necessary.
• Sponsors should consider the nature of the data, and apply reasonable, appropriate lengths to variables. For example:
o The length of flags will always be 1

Dear authors,

Noticed a couple of issues with labels:

- EX dataset: the label for EXTRT per SDTM IG 3.2 is 'Name of Treatment', but the validator for SDTM 3.2 wants 'Name of Actual Treatment'

- TI dataset: the validator wants the label for IETESTCD to be 'Inclusion/Exclusion Criterion Short Name', which is longer than 40 character limit. per SDTM IG 3.2 the label is 'Incl/Excl Criterion Short Name'

Any reason for these discrepancies?

Thanks,

   Leonid

Hi CDISC,

I'm currently working on Legacy Study with Data having no proper structure(Pre-CDISC format).

In MH Domain, I have data like "Yes","No","Unknown", "Free text(for Suppqual)". After transposing the data, I got all MH variables -->MHTERM
eg:

 In my study, for one of the subject, DSSDTC for study completion is reported as 2015-05-30, however this information was collected on 2015-05-31 so we populated DSDTC on 2015-05-31. This subject had AE on 2015-05-31 which triggers SD0080 becuase AESTDTC is later than latest dispostion date of 2015-05-30. This happens for quiet a few subjects.This is not data issue nor SDTM issue. How do we handle this issue?

Thanks,

Sukanya

Hi,