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2017-09-28 05:20

Posting: # 17834
Views: 2,227

 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!


2017-09-28 08:55

@ TK
Posting: # 17836
Views: 1,927

 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.

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Best regards,

"(...) targeted cancer therapies will benefit fewer than 2 percent of the cancer patients they’re aimed at. That reality is often lost on consumers, who are being fed a steady diet of winning anecdotes about miracle cures." New York Times (ed.), June 9, 2018.

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

@ ElMaestro
Posting: # 17838
Views: 1,854

 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.


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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