Pooling Study or Integration study

Pinnacle 21 Support Define.xml
1

Hi Bharath,

Yes, you can use “Predecessor” as an Origin in pooled database if it’s an exact copy of a variable from other study. Exact copy means that variable name and values are the same.

For example, if you have AEREL=“Yes”, “No” in study 1 and AEREL=“Not Related”, “Possibly”, “Definitely” in study 2.

If you keep original terms as then Origin would be “Predecessor”. However, it is uncommon approach for data integration to have different terms for the same info like “No” and “Not Related”.

If you convert your study 2 terms into “Yes” and “No”, then Origin would be “Derived”.

Kind Regards,
Sergiy

2

Dear Sergiy,

I appreciate your prompt response for my question.

Regards,

Bharath, V

3

Can “Predecessor” be used as ORIGIN for those variables which has been inherited from one of the study included as part of integration in SDTM?