CDISC/ ADaM IG/ Pinnacle 21

[DinoPut]

Hi

In a pooled study with data from multiple studies:

Study 1: could have TRT01AN from 1 through 5.

Study 2: could have TRT01AN from 1 through 5.

When both study 1 and study 2 are pooled together, should TRT01AN be re-ordered from 1 through 10 or can they be left as is. 

If they are left as is, each value of TRT01AN would have 2 TRT01A's associated with it. Would that cause any problem in terms of CDISC Compliance (Pinnacle 21)?

[Jagadishkatam]

Since these are two studies the USUBJID will differ and the treatments will be unique for that USUBJID. The USUBJID is unique as it is concatenated with the studyid and subject id.

We could leave the TRT01AN as is.