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

2. Sample management/Central labs/Biomarkers
“Dr Green drew the short straw at the pre-inspection meeting”.

3. 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)

4. What sort of samples do we take?
– Blood
• Whole
• Serum
• Plasma
– Tumour
– Skin
– Urine
– Faeces
– Saliva

5. How do we identify them?

6. What sort of problems do we see?

7. Label incorrectly attached

8. Non-Sponsor/no barcode label attached

9. Crossed out information on label

10. Crossed out information on label

11. FFPE Tissue with no label

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

13. • What do we
do about
them?
• How do we
try and stop
them
happening?

14. 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

16. Every
Sample
Matters!