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RegisterExpedited review from IEC [Regulatives / Guidelines]
Dear Vivekanand,
In ICH GCP, expedited review is only applicable to minor change(s) in ongoing trials that have the approval/favourable opinion of the IRB/IEC.
Even if it is identical to another trial already performed, a new trial is a new trial and you can't go for expedited review. How long the IRB/IEC takes to discuss on the project is their problem, but it has to take place at a convened meeting.
Regards
Ohlbe
In ICH GCP, expedited review is only applicable to minor change(s) in ongoing trials that have the approval/favourable opinion of the IRB/IEC.
Even if it is identical to another trial already performed, a new trial is a new trial and you can't go for expedited review. How long the IRB/IEC takes to discuss on the project is their problem, but it has to take place at a convened meeting.
Regards
Ohlbe
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Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- Expedited review from IEC vivekanand 2012-09-26 06:55
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Expedited review from IEC drgunasakaran1 2012-09-26 09:14
- Expedited review from IECOhlbe 2012-09-26 10:17
- Similar ≠ same Helmut 2012-09-26 15:03
Ing. Helmut Schütz