SEND

 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

Hello all,

I'm having the following scenario:

I had to add an extra column into the clinical observations xpt.

a) If I don't describe the extra column in define.xml, the following error is reported by the validator: "SD0060 - Variable in dataset is not present in define.xml", which makes sense (since all variables in .xpt must also be described in define.xml);

b) However, if I describe it in define.xml (refer it in the ItemGroupDef for CL and describe it in a new ItemDef below), an warning is still reported: "SE0063 - SEND/dataset variable label mismatch".

How soon do you expect the rules for validating SEND to be available?

Is there an expected date of release of the SEND Validator?