SDTM

Description

Technical support questions about SDTM standard and validation rules

December 21, 2014

I was surprised to find, as well in the FDA worksheet as in the OpenCDISC implementation, rules FDAC0154 "Missing value for --ORRESU, when --ORRES is provided" and FDAC0169 "Missing value for --STRESU, when --STRESC is provided".
We all know that there are so many tests that have no unit. A simple example of an ORRESU for which there is no unit are "NEGATIVE" (many tests), or for the test "pH".
So this rule is ... damned wrong" (thanks FDA!). Similar for FDAC0169.

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December 20, 2014

Is Rule FDAC0128 (Missing --STDY variable, when --STDTC variable is present) implemented in OpenCDISC Community 2.0?
I was testing using an MH dataset (the one that came with define.xml 2.0 spec) which has a MHSTDC column, but no MHSTDY column.
In some cases MHSDTC is a partial date, sometimes a full date.
However, I do not see any errors about FDAC0128 in my output.

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December 19, 2014
If we have a define.xml file associated with our data which type of checks will do opencdisc could you please provide me some examples? while validating the SDTM xpt file.
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December 17, 2014

I am getting some warning messages in the Validator 2.0 for DSDECOD values that are not found in the Completion/Reason for Non-Completion codelist.  The controlled terminology for DSDECOD should be based on what the DSCAT value is for each record.  DSDECOD values of "INFORMED CONSENT OBTAINED" and "RANDOMIZED" should be permitted without a warning message when the DSCAT is "PROTOCOL MILESTONE".  You may also need to allow for other values when DSCAT is "OTHER EVENT".

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December 16, 2014
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?
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December 16, 2014

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.

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December 16, 2014

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.

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December 10, 2014

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.

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December 4, 2014

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

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November 19, 2014

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.

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