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

posted by jag009  – NJ, 2019-04-23 17:22  – Posting: # 20211
Views: 984

Hi Ohlbe,

» 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.

Do you know why some sponsors want to have their samples kept until application approved? From EMA or FDA, is there a requirement mentioned in any of the guidances? We are doing this (store samples) as well and I wonder why we need to if the age of the samples exceeds the long term stability date. I asked my folks and their answer was "we can always ask the CRO to extended the stability" :confused:

Thanks
J

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