TK ☆ Thailand, 2017-09-28 07:20 (2400 d 05:40 ago) Posting: # 17834 Views: 4,312 |
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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 (2400 d 02:06 ago) @ TK Posting: # 17836 Views: 3,654 |
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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 (2399 d 04:29 ago) (edited by Ohlbe on 2017-09-29 10:18) @ ElMaestro Posting: # 17838 Views: 3,566 |
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