d Daniel
on

 

Hello,

  First,  in advance, apologies if this is covered under another thread; I've looked and don't see it.

  I just installed OpenCDISC Community 2.0, and have 1 custome domain, call it BI, which is a findings domain.  When creating the specs from the transport files from all the SDTM datasets, both the BI dataset and the DI dataset have a problem(s).  For the datasets tab, the structure, primary keys, and other columns don't get populated.  Also, in the variables tab, the columns "Mandatory", and some others, don't get populated.  

  Has anyone in the community seen this, or is Pinnacle aware of this? I might understand BI, if custom, but DI is part of the device supplement and that is a bit confusing for me.

  If you'd like the define.xlsx file that is created upon executing OpenCDISC on the datasets, I can send that to Pinnacle.

  Thanks very much,


Dan.

Forums: Define.xml

s Sergiy
on December 26, 2014

Hi Dan, 

1. OC Define.xml tool uses SDTM IG metadata to pre-populate some attributes for standard domains. Properties for custom domains are not defined by SDTM and expected to be populate by user.

2. A current version of OpenCDISC does not support Device and Associated Persons standards.

Kind Regards,

Sergiy 

d Daniel
on December 26, 2014

Thanks Sergiy.  I will note that the other Device domains in this study, DX, DU, etc, didn't encounter the same issue DI did. 

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