General Discussion

Hello all,

Where can I find a more detailed description of the messages level as included into the validation report?

I assume that the presence of an Error in the validation report means that FDA will not accept that submission. Is this assumption correct? And what about Warnings? They must absolutely be corrected before the submission, or the dataset will be accepted by FDA even though the validator reported some Warnings?

Thank you!

Hi all,

I just started looking into the OpenCDISC app and it is pretty impressive.

We recently installed a copy for use across our large department composed of far-flung groups and independent developers.

My quick question is--is there a possibility to revise the interface so that the user is given control over the paths for configuration files, define.xml, and reports?

We want to be able to stay with a single installation and let users spawn sessions while reading and writing in separate folders that are appropriate for their groups.

Hi, There:

Just wonder if anyone has implemented Webstart for OpenCDISC. I tried to deploy OpenCDISC in Maven Webstart.  Everyting looked fine after I packaged the program. But when I tried to run it, nothing showed up. No gui interface appeared and no error message as well. Any suggestions are much appreciated.

yc

Dear OpenCDISC expert,

      We have some question related to sourcecode contribution here.   We would like to know:

If we want to contribute souce code one day,

1. What kind procedure we should go through, is anywhere on your web side posted or download guide line.

2. What kind regulation OpenCDISC has setup need to be followed

3. Source code side, what kind modification need to adding/edit to easier the process for merging to the major trunk.

Thank you very much for assistance!

Hi OpenCDISC expert,

     I am currently working on some application related to clinical validator process.  Interested about Validator1.2.1, however, could not download the source code (at one time, as zip file) to take a look.  Is there anyway you could assistant me on this?

   Thank you in advance

I am fairly new to OpenCDISC and I have been reading the website and have alot of questions about how to do a few things. I need to suppress alot of the errors that keep popping up for extensible codelists where the values are ok, but aren't apart of the software. I am wondering if you can add informations to the file name SDTM Terminology Fixed.xml in order to help with the issue stated above, or is there another way to do this? 

Also, do you have to add user-defined domains to the configuration files in order to get them validated??

Hi All,

I want to check the Domail "AE" with SDTM Domail "AE" to see if the

Variable, Type, Len, Dlen, Format, InFormat, Label  are the same as SDTM required.

I like this site.

Appriciated your all hard work,

Doris

Hello,

When running Open CDISC, is there an option to include additional controlled terminology (Sponsor-Specific or Internal) to the SDTM CT where the Codelist is Extensible before running data through Open CDISC? I am seeing many errors that can be eliminated if I had this option?

Thanks,

Donna

I'm wondering if opencdisc is a validated tool. If yes, where can I get the specifications, test cases, and all the required documentation.

Does anybody know the answers?

Thank you,

Daniel Mannino

Hello.

I wanted to start by saying that OpenCDISC is a great tool and does most of the heavy lifting for both SDTM validation and creation of define.xml... Great effort.

Having said that I have the following questions/comments on the define.xml file: