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

posted by ElMaestro  – Belgium?, 2019-04-23 18:15 (582 d 00:44 ago) – Posting: # 20212
Views: 1,872

Hi jag,

» "we can always ask the CRO to extended the stability" :confused:

"...if we stored the samples along with appropriate QC's."

The thing is regulators throw a curve ball every now and then. Sometimes there is even a degree of rationale behind it. If the study is inspected or someone asks for re-analysis or any other activity of this type then you simply have much better chances of answering if you have the samples and the QCs still frozen.
CRO compliance suddenly questioned by an evil inspector? Send the B-set to another CRO, show BE with those samples, and Bob's your uncle!

I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

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