Log in
RegisterBlood sample storage [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2013-10-31 16:30 (4626 d 05:55 ago) – Posting: # 11843
Views: 4,360
Hi Melkor,
Not that I recall.
No (did you read it?). CROs have different policies about storage periods:
❝ Could anyone inform me if there is a specific time frame that blood samples have to be stored after the completion of a BE study?
Not that I recall.
❝ Is this refered to ICH GCP?
No (did you read it?). CROs have different policies about storage periods:
- Until the final analytical report is accepted by the sponsor.
- Until the maximum validated storage interval is reached.
- Longer, if the sponsor pays for it – and make clear that eventual reanalysis is not valid.
- We kept all samples of one subject essentially forever – to be able to prove that the study was not fabricated (aka in silico BE).
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Blood sample storage Melkor 2013-10-31 11:33
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Blood sample storageHelmut 2013-10-31 15:30
- Blood sample storage Melkor 2013-10-31 15:51
- Blood sample storage jalgorta 2015-08-03 17:53
- Blood sample storage Melkor 2013-10-31 15:51
- Blood sample storageHelmut 2013-10-31 15:30
Ing. Helmut Schütz