Bioequivalence and Bioavailability Forum • Allocate screened volunteers to another BE project

TK
☆

Thailand,
2017-09-28 07:20
(2395 d 04:27 ago)

Posting: # 17834
Views: 4,292

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
★★★

Denmark,
2017-09-28 10:55
(2395 d 00:52 ago)

@ TK
Posting: # 17836
Views: 3,639

Allocate screened volunteers to another BE project

Post reply

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.

—
Pass or fail!
ElMaestro

TK ☆ Thailand, 2017-09-29 08:32 (2394 d 03:15 ago) (edited by Ohlbe on 2017-09-29 10:18) @ ElMaestro Posting: # 17838 Views: 3,550	Allocate screened volunteers to another BE project Post reply
	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]