SDTM

We are createing custom domains based on FA - ZV and ZM. The error messages show missing FA variables but this does not seem correct Can you comment?

Don't know whether this fits in this section, but there is no section yet on transformations.
OpenCDISC 2.0 Community edition.

When I transform an SDTM-XPT file to Dataset-XML, I get lines like:
<ItemData ItemOID="IT.LB.LBMETHOD" Value=""/>

This is however not allowed in Dataset-XML. The specification states:
"Dataset variables with missing or null values ... are not included as ItemData elements".
Such lines should be filtered out when creating the output.

Using OpenCDISC 2.0 Community Edition, configuration SDTM-IG 3.1.2, using Dataset-XML files and a define.xml 2.0 I get an Warning for almost every record "EGSTRESC value not found in 'ECG Result' extensible codelist" - CT2002 / FDAC341 "EGSTRESC value not found in 'ECG Result' extensible codelist".
The records that produce the error are all EGSTRESC values that represent a numeric value.

Hi, I have a sponsor who needs the original units (a mix of CN, US, and SI units), Conventional units, and SI units all within the lab data for a study.  I’ve never come across the situation where I’d technically need two sets of LBSTRES variables in the SDTM data before.  I considered sending one set of results and units to SUPPLB, or even making a “non-standard” findings domain for the other units.  These do not seem optimal.

In the OpenCDISC Validator (v1.5) 3.1.3 configuration file, a

Hi,

We pick up these flags a lot, especially in trials that are ongoing, or that have longer monitoring of AEs, etc.  However, I'm not finding these violations picked up in FDA's new checks, published yesterday, but OpenCDISC 1.5 marks these as an Error.

Hello,

I am getting CT0169 and CT0170 error in OpenCDISC QSTESTCD and QSTEST are not using CT however values look identical. My values are as follows:

QSTESTCD = 'BARS0101' QSTEST = 'BARS01-Objective'

QSTESTCD = 'BARS0102' QSTEST = 'BARS01-Subjective, Awareness'

QSTESTCD = 'BARS0103' QSTEST = 'BARS01-Subjective, Distress'

QSTESTCD = 'BARS0104' QSTEST = 'BARS01-Global Clinical Assessment'

Hi,

Please let me know which version of SDTM terminology is using for define.xml validator in OpenDISC V1.5 and in which folder the SDTM terminology file is present.

Thanks,

Bhaskaran

Hi, I've been trying to validate a test database and I've just come across the rule SD0009: "No qualifiers set to 'Y', when AE is Serious".

I'm using SDTM IG 3.1.3 and I can't find this referenced there - can someone tell me where it comes from?  And whether it's mandatory or just recommended, as the qualifiers are not something we'd normally collect?  (It gives a Warning rather than an Error.)

Thanks!

I have three FA domain and in those DOMAIN value set to FA. what should be the value for Rdoamin in RELREC. currently I setted to FAxx but then I am getting SD0072 error.

Thanks & Regards

Deepali