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RegisterPrior and concomitant medication [Study Performance]
Dear All,
For a BA BE study if protocol does not specify any prior or concomitant medication what shall be captured in the integrated study report in the sec. 9.4.7?
Secondly, if a subject is having AE in period 02 check-in and was medicated and withdrawn from the study. Does the medication should be considered as Concomitant medication?
Thanks and regards,
Borsha
For a BA BE study if protocol does not specify any prior or concomitant medication what shall be captured in the integrated study report in the sec. 9.4.7?
Secondly, if a subject is having AE in period 02 check-in and was medicated and withdrawn from the study. Does the medication should be considered as Concomitant medication?
Thanks and regards,
Borsha
Complete thread:
- Prior and concomitant medicationVarsha 2012-06-16 08:38
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Prior and concomitant medication drgunasakaran1 2012-06-16 09:02
- Prior and concomitant medication Varsha 2012-06-16 12:22
- Prior and concomitant medication drgunasakaran1 2012-06-16 09:02
Ing. Helmut Schütz