Every Sample Matters The Global Issues of Managing, Transporting and storing Biological Specimens for Drug Safety and Biomarker Analysis Dr Helen Green

Sample management/Central labs/Biomarkers

“Dr Green drew the short straw at the pre-inspection meeting”.

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)

What sort of samples do we take?

– Blood • Whole • Serum • Plasma

– Tumour – Skin – Urine – Faeces – Saliva

How do we identify them?

What sort of problems do we see?

Label incorrectly attached

Non-Sponsor/no barcode label attached

Crossed out information on label

Crossed out information on label

FFPE Tissue with no label

Multiple blocks per bag (where there is only one sample)

• What do we do about

them?

• How do we try and stop them happening?

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

Every Sample Matters!