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RegisterProtocol Compliance [GxP / QC / QA]
Dear Madam/Sir,
In BA/BE study, if a Subject is lost to followup i.e., he has not given safety analysis and he comes after 2 months of the last dose. But protocol says safety analysis must be taken within 30 days of the last dose. In this regard, what to do?
Thanks in advance.
Kind Regards,
In BA/BE study, if a Subject is lost to followup i.e., he has not given safety analysis and he comes after 2 months of the last dose. But protocol says safety analysis must be taken within 30 days of the last dose. In this regard, what to do?
Thanks in advance.
Kind Regards,
Complete thread:
- Protocol Complianceraghavendra_s 2010-04-03 09:53
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Protocol Compliance Dr.Sridhar 2010-04-03 11:04
- Protocol Compliance drgunasakaran1 2010-04-03 13:20
- Post treatment safety after 30+ days? Helmut 2010-04-03 14:38
Ing. Helmut Schütz