every sample matters
TRANSCRIPT
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Every Sample Matters The Global Issues of Managing, Transporting and storing Biological Specimens for Drug Safety and Biomarker Analysis Dr Helen Green
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Sample management/Central labs/Biomarkers
“Dr Green drew the short straw at the pre-inspection meeting”.
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Clinical trial samples
• Why do we take them? – Research questions that are directly or indirectly linked to the objective
of a clinical trial • Drug action (pharmacological Biomarker) • Drug effect (Predictive Biomarker) • Disease outcome (prognostic Biomarker)
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What sort of samples do we take?
– Blood • Whole • Serum • Plasma
– Tumour – Skin – Urine – Faeces – Saliva
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How do we identify them?
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What sort of problems do we see?
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Label incorrectly attached
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Non-Sponsor/no barcode label attached
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Crossed out information on label
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Crossed out information on label
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FFPE Tissue with no label
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Multiple blocks per bag (where there is only one sample)
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• What do we do about
them?
• How do we try and stop them happening?
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What do we do to track and monitor samples?
Blood collection tubes for plasma or serum collection are to be labeled with non-bar-coded labels.
There is a corresponding storage tube for that patient blood sample, and it has been labelled with a bar coded label
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Every Sample Matters!