Retention of clinical biosamples / blank matrices [Regulatives / Guidelines]

posted by Ohlbe – France, 2017-02-20 11:51 (1315 d 19:34 ago) – Posting: # 17090
Views: 3,374

Dear Vivek,

I am not aware of any retention period mentioned in any of the main BE guidelines. It is a matter of agreement between the sponsor and the CRO.

Usually CROs keep the samples until the study report is approved by the sponsor. This makes sense, of course. Some sponsors will ask the CRO to keep the samples until the application is approved. Most CROs will charge for storage beyond a few months.

In any case it makes little sense to store the samples beyond their demonstrated stability period. If they are stored for a longer duration: I would recommend to store QC samples along with them. If the samples need to be re-analysed, you can then demonstrate stability (or instability).

Regards
Ohlbe

Complete thread:

Activity
 Admin contact
21,080 posts in 4,397 threads, 1,468 registered users;
online 3 (0 registered, 3 guests [including 2 identified bots]).
Forum time: Monday 08:26 CEST (Europe/Vienna)

A central lesson of science is that to understand complex issues
(or even simple ones), we must try to free our minds of dogma and
to guarantee the freedom to publish, to contradict, and to experiment.
Arguments from authority are unacceptable.    Carl Sagan

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5