SEND

Hi all,

I'm getting this Error reported for the following scenario:

TSSEQ   TSGRPID   TSPARMCD   TSPARM   TSVAL

1    1    TFCNTRY    Test Facility Country    USA
1    2    TFCNTRY    Test Facility Country    CHE

Do you think it is normal to get this error, that TSSEQ is the same (1) for TFCNTRY when the TSGRPID values are different?

Hi all,

Please see below a set of observations made after running some tests with Validator 1.5 on some SEND datasets. The info was also sent by e-mail, but is also shared here for the public review.

Hello all,

I am trying to implement a new rule. The rule description is:

Missing values for DSDTDY and --DY and --DTC & RFSDTC. Either of these three timing variables should be populated: [DSSTDY] or [--DY] or [DTC and DM, RFSTDTC].

This rule is applied to OM,MA,MI,TF,DM.

I implemented as follwoing:

--------- System Information ---------
 Version: 1.4.1
     JRE: 1.7.0_01
      OS: Windows 7 6.1 amd64
--------------------------------------

java.lang.IllegalArgumentException: The variable USUBJID does not exist in this DataRecord
    at org.opencdisc.validator.data.DataRecord.getValue(DataRecord.java:130)
    at org.opencdisc.validator.data.DataSupplement.<init>(DataSupplement.java:59)

Hello all,

I've noticed some differences of the validation report on the same studies, when using:

a) the GUI 1.4.1 version available for download on the website;

and

b) the command-line version from the SVN repository.

The version available now on SVN contains some improvements / bug fixes on top of the 1.4.1 released version? Or it is an older, unmaintained version?

What would you recommend using for our internal tests for now?

Thanks!

Hi all,

As you know, Define 2.0 specifications were recently released: http://www.cdisc.org/define-xml .

I think OpenCDISC Validator 1.4.1 works with Define-XML 1.0, yes?

Do you think that a next release OpenCDISC Validator will be adapted to work with Define-XML 2.0?

Or better than that, allow support for both 1.0 and 2.0 define versions? I understand that Define-XML 2.0 is not backwardly compatible with Define-XML 1.0.

Best regards,

Amelia

 Are you planning to create a validation rule set that matches the validation rules FDA published about Sept 4, 2013 for nonclinical dataset for submission to CDER?  They can be found at the following site as the last bullet under 1.6:   

Hi guys,

Hello,

We ran into a situation where we had domain XPT files that were present in the package, but there wasn't any corresponding information in the define.xml file for those domains.  The validator does currently provide a means to detect this scenario (which really is an error in the define file creation), but it would be very useful if it did.

Hi,

I am using OpenCDISC to generate the define.xml file for a submission.  Under the configuration drop down, there is no option for SEND even though it's available under the Validate Data option.  So I select the config-sdtm-3.1.2-amend-1.xml option and generate. 

The define.xml generates, but it appears to be missing information on SEND specific variables.  Is there a way to have it automatically provide those?  Or do I have to manually edit the define.xml to add that information?

Thanks,
Matt