s Shakuntala
on

 

I'm working on creating define.xml for a study. We're incorporating external lab data in LB domain. Due to need for reconciliation, the external lab data was imported in study database i.e. data management team created separate CRFs for this externally imported lab data.

My question is, as this external lab data is imported to study database:

Do we need to annotate the CRFs for this lab data. If yes, then what will be the origin "CRF" or "eDT"? 

 

 

Forums: Define.xml

j Jozef
on May 16, 2020

An easy one ...

If the lab data was copied into the (e)CRF, the Origin is usually set to "CRF".
If it is not, and the data comes directly from the database, Origin is set to "eDT".
In the latter case, there is nothing to annotate.

 

 

 

 

Lex
on May 17, 2020

Also keep in mind that you will have to create value level metadata in case lab data is coming from multiple sources. For an excellent explanation of this concept, see the following article by Kevin Burges on LinkedIn: 

https://www.linkedin.com/pulse/how-describe-multiple-origins-value-define-xml-2-kevin-burges/

 

j Jozef
on May 17, 2020

Thumbs up for Lex and Kevin ... ;-)

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