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Registerprotocol amendment [Regulatives / Guidelines]
Dear Dr Gopal,
Yes, you can take amendment in between study, specially when it is not changing the time points for collection and drug/response analytical parameters between two periods. You can take amendment approval from IEC anytime. This is specially accepted considering subject safety on priority.
if drug analysis method or collection time points are changed in amendments, then you need to conduct the both periods again.
Regards,
Dr.dds
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Edit: Full quote removed. Please see this post! [Ohlbe]
Yes, you can take amendment in between study, specially when it is not changing the time points for collection and drug/response analytical parameters between two periods. You can take amendment approval from IEC anytime. This is specially accepted considering subject safety on priority.
if drug analysis method or collection time points are changed in amendments, then you need to conduct the both periods again.
Regards,
Dr.dds
--
Edit: Full quote removed. Please see this post! [Ohlbe]
Complete thread:
- protocol amendment drgopal 2008-01-21 07:23
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Approval of amendment Helmut 2008-01-21 14:52
- protocol amendmentdrdds 2008-01-23 06:24
Ing. Helmut Schütz