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RegisterAllocate screened volunteers to another BE project [Regulatives / Guidelines]
Hi TK,
In my opinion this should be fully OK with a re-consent, assuming the in-ex criteria are the same. I do not know of any guidance that addresses this situation specifically, but of course there could be local regs in place which I don't know about.
I believe your way forward is even the ethical one as you will need less "total screening" and needlepricks and pain and fuss. There is as I see it no particular added risk to the subjects, the change in orientation does not per se affect their rights or the expected outcome. A perspective: In other countries they make extensive use of screening IC+study IC. That means they have a bunch of volunteers who are screened, and whose screening status is valid for a month or more, and can be ad-hoc allocated to studies as appropriate.
So, I'd say go ahead.
The Sponsor on the other hand, has a little issue that could appropriately be addressed with some RCA and CAPA work, perhaps.
❝ Question is.. Can we allocate these screened volunteers to another project Project B with re-consent process? Is there regulation for this?
In my opinion this should be fully OK with a re-consent, assuming the in-ex criteria are the same. I do not know of any guidance that addresses this situation specifically, but of course there could be local regs in place which I don't know about.
I believe your way forward is even the ethical one as you will need less "total screening" and needlepricks and pain and fuss. There is as I see it no particular added risk to the subjects, the change in orientation does not per se affect their rights or the expected outcome. A perspective: In other countries they make extensive use of screening IC+study IC. That means they have a bunch of volunteers who are screened, and whose screening status is valid for a month or more, and can be ad-hoc allocated to studies as appropriate.
So, I'd say go ahead.
The Sponsor on the other hand, has a little issue that could appropriately be addressed with some RCA and CAPA work, perhaps.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Allocate screened volunteers to another BE project TK 2017-09-28 05:20
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Allocate screened volunteers to another BE projectElMaestro 2017-09-28 08:55
- Allocate screened volunteers to another BE project TK 2017-09-29 06:32
- Allocate screened volunteers to another BE projectElMaestro 2017-09-28 08:55
Ing. Helmut Schütz