Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2017-10-21 02:58 CEST (UTC+2h)

2017-09-28 05:20

Posting: # 17834
Views: 535

 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: 426

 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.

I could be wrong, but…

Best regards,

- since June 2017 having an affair with the bootstrap.

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

@ ElMaestro
Posting: # 17838
Views: 354

 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]
Back to the forum Activity
 Thread view
Bioequivalence and Bioavailability Forum | Admin contact
17,396 Posts in 3,726 Threads, 1,074 registered users;
21 users online (0 registered, 21 guests).

The difference between a surrogate and a true endpoint
is like the difference between a cheque and cash.
You can get the cheque earlier but then,
of course, it might bounce.    Stephen Senn

BEBAC Ing. Helmut Schütz