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Back to the forum  Query: 2018-05-24 17:56 CEST (UTC+2h)
 
TK
Junior

Thailand,
2017-09-28 05:20

Posting: # 17834
Views: 1,411
 

 Allocate screened volunteers to another BE project [Regulatives / Guidelines]

Hi there,

I have a question that still have noone can give a clear answer.

Thing is..volunteers have passed consent and screening process for a particular project, let's say project A but this project has cancelled later because the client cannot provide the test and reference products on time before start dosing. The plan will be delay more than a month.

Question is.. Can we allocate these screened volunteers to another project Project B with re-consent process? Is there regulation for this?

Thanks a million!

TK
ElMaestro
Hero

Denmark,
2017-09-28 08:55

@ TK
Posting: # 17836
Views: 1,186
 

 Allocate screened volunteers to another BE project

Hi TK,

» 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.

“A ten-year, double-blind study from the Mayo Clinic concluded that even in late stages of dementia, the last to go is the lobe of the brain in charge of cafeteria layout.” (Serge Storms/Tim Dorsey).


Best regards,
ElMaestro

- Bootstrapping is a relatively new hobby of mine. I am only 30 years late to the party.
TK
Junior

Thailand,
2017-09-29 06:32
(edited by Ohlbe on 2017-09-29 10:18)

@ ElMaestro
Posting: # 17838
Views: 1,116
 

 Allocate screened volunteers to another BE project

Dear ElMaestro,

Thank you so much for your answer. I will discuss with my team and further ask Thai regulatory authorities.

TK


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]
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