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RegisterCan of worms [Regulatives / Guidelines]
Hi jag,
I agree with Helmut.
My top three for scientific advice is Sweden, Sweden, and Sweden.
You will of course not fall for the temptation to take sc. advice in the countries which are the most attractive business-wise.
It will likely be a 10(3). This is Europe, so if the study is conducted here you will be facing an IEC, not IRB, technically. And note that the IEC may be a bottle-neck. They can say no, even if the authority will say yes.
Try and discuss the case with different CROs, I think you find that several of them (in EU their numbers are limited) have been in situation before and have been discussing the matter with other sponsors + authorities as well as with IECs.
What are you actually going to measure?
I agree with Helmut.
My top three for scientific advice is Sweden, Sweden, and Sweden.
You will of course not fall for the temptation to take sc. advice in the countries which are the most attractive business-wise.
It will likely be a 10(3). This is Europe, so if the study is conducted here you will be facing an IEC, not IRB, technically. And note that the IEC may be a bottle-neck. They can say no, even if the authority will say yes.
Try and discuss the case with different CROs, I think you find that several of them (in EU their numbers are limited) have been in situation before and have been discussing the matter with other sponsors + authorities as well as with IECs.
What are you actually going to measure?
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- EMA: What do I need if I want to run an overdose study jag009 2020-01-28 20:12 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- EMA: What do I need if I want to run an overdose study Helmut 2020-01-29 16:52
- EMA: What do I need if I want to run an overdose study jag009 2020-01-30 04:32
- Can of worms Helmut 2020-01-30 13:32
- Can of wormsElMaestro 2020-01-30 15:12
- Can of worms jag009 2020-02-03 20:28
- Can of worms jag009 2020-02-03 20:34
- Can of wormsElMaestro 2020-01-30 15:12
- Can of worms Helmut 2020-01-30 13:32
- EMA: What do I need if I want to run an overdose study jag009 2020-01-30 04:32
- EMA: What do I need if I want to run an overdose study Ohlbe 2020-01-30 17:32
- EMA: What do I need if I want to run an overdose study jag009 2020-02-03 20:23
- EMA: What do I need if I want to run an overdose study Helmut 2020-01-29 16:52
Ing. Helmut Schütz