My answer reverts to whether you want to keep them for any reason. If you do, then establish the stability during method validation to cover the processed samples and make sure that your informed consent covers sample retention in general.
Example 1: We keep DNA extracts from tissue samples because heterogeneous samples would not expect the next extraction to be the same. So if we are looking to link exploratory work back to the original results, we keep the nucleic acid. Also, often more stable than the tissue sample itself since nucleases not present in the extracted DNA.
Example 2: We don't keep extracts from dried blood on volumetric devices. The second device is a better source if we want to go back for additional analysis.
So my short answer is that I don't think you have to keep them to meet any regulatory expectation, but that you can if appropriately consented and you establish stability to cover the storage.
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Joleen White Ph.D.
AAPS 2024 Global Health Community Chair
Bioanalytical 101 Course Development
Senior Bioassay Development Lead
Gates Medical Research Institute
Cambridge MA
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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Original Message:
Sent: 08-06-2024 10:04
From: Rui Wang
Subject: Question about study sample archives
Hello everyone,
I have a general question about study sample archives. When you generate intermediate/processed samples like DNA, RNA or protein samples which are extracted from the study samples, do you need to archive these processed samples after the study is final?
Thank you,
Rachel
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Rachel Wang, Ph.D.
Bioanalytical assay development lead
Spark Therapeutics
Philadelphia, PA.
[email protected]
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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