Retention samples [Regulatives / Guidelines]

posted by Ohlbe – France, 2013-07-15 13:44 (4727 d 00:38 ago) – Posting: # 10974
Views: 3,278

Dear John,

What if for some obscure reason the sponsor sent the CRO more test article that would be needed to run the study + the retention samples. Would they be able to ask the CRO to send them back the excess test article, and just keep the amount needed as retention samples ? I don't see a reason why this wouldn't be accepted, as long as the sponsor do not select themselves which bottle has to be sent back and which should be kept as retention sample.

Regards
Ohlbe

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