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RegisterChanges in facility after period I [Bioanalytics]
Dear Esreddy,
As per the guidelines the protocol should mention the analytical facility, if the sponsor latter wants to change the facility, then it would lead to protocol amendment and the same to be approved by the Ethics commitee.
Have a change control document perapred mentioning the reason for the facility change.
Regards
Krish
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Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]
As per the guidelines the protocol should mention the analytical facility, if the sponsor latter wants to change the facility, then it would lead to protocol amendment and the same to be approved by the Ethics commitee.
Have a change control document perapred mentioning the reason for the facility change.
Regards
Krish
---
Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]
Complete thread:
- Changes in facility after period I esreddy 2009-04-15 06:35
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Protocol amendment pmgjoshi 2009-04-15 07:50
- Protocol amendment esreddy 2009-04-15 19:13
- No full quotes ! Ohlbe 2009-04-15 22:56
- Protocol amendment esreddy 2009-04-15 19:13
- Changes in facility after period Ikrish3108 2009-05-04 10:10
- Protocol amendment pmgjoshi 2009-04-15 07:50
Ing. Helmut Schütz