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Operational Best Practices for Handling   and Distributing Low-Volume Specimens                 in Asia Pacific    Dorevit...
Importance of Communication,       Understanding and Experience• Communication and Understanding  –   Language  –   Cultur...
Asia Pacific Region Countries  • Australia         • Philippines  • New Zealand       • Singapore  • Hong Kong         • S...
Study Set Up• Protocol review• Region specific requirements• Global Laboratory Specification Document  (GLSD)  – Agreed st...
Pre-analytical Considerations•   Documentation – region specific•   Supplies•   Investigator Site•   Specimen Consideratio...
Documentation (1)• Region specific requirements  – Sample Destruction Declaration (New Zealand)  – Material Safety Data Sh...
Documentation (2)• Import permit/customs declaration for kits and  supplies  – all kit components listed  – to CRA for adv...
Supplies•   Requisition Forms•   Kits – ACM Kit-Kaddy•   Other supplies•   Packaging•   Investigator specific pre-printed ...
Investigator Site (1)• Training  – Investigator Meeting  – Site Initiation Visits• Support  – Investigator Laboratory Manu...
Investigator Site (2)•   Correct requisition form and kit for visit•   Specimen collection•   Specimen preparation•   Pack...
Specimen Considerations•   Sample viability•   Time•   Temperature•   Preservative•   Sample agitation    – CBC - disrupti...
Transportation• Booking instructions• Last booking/call time• Last pick up time                           13
Shipping Timetable - JapanLocation    Last Call Time             Last Pick-Up TimeTokyo       18:00 -1 (previous day)    1...
Transportation•   Booking instructions•   Last booking/call time•   Last pick up time•   Transit Times•   Monitoring    – ...
Sample Problems•   Incorrect sample type•   Insufficient sample•   Thawed frozen samples•   Frozen ambient samples•   Lost...
Effect of Frozen Sample ThawingSerum Insulin (GTT)            -20oC   4oC (48h)Fasting (RR: <12 mIU/L)         31        1...
Receipt at Laboratory• Specimen integrity  – Sample type  – Volume  – Temperature• Consistency check  – Tube labelling  – ...
Critical Factors•   Communication•   Cooperation•   Knowledge•   Teamwork•   Traceability                     19
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Operational Best Practices for Handling and Distributing Low-Volume Specimens in Asia Pacific Robyn Wootton, Clinical Trials Manager Dorevitch, an ACM Global strategic alliance partner

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The lifecycle of a specimen, which starts at collection and ends at database lock, can be prone to human error along each step of the testing process, particularly when conducting global clinical trials in more remote ends of the world. Sponsors need to ensure the integrity of the specimen throughout this process, while balancing the relative cost of logistics.

Based on lessons learned from managing global clinical trials testing, ACM Global Lab and its partners will share their insights on monitoring and oversight on patient safety, safeguarding sample integrity, and good business sense.

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Operational Best Practices for Handling and Distributing Low-Volume Specimens in Asia Pacific Robyn Wootton, Clinical Trials Manager Dorevitch, an ACM Global strategic alliance partner

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  2. 2. Operational Best Practices for Handling and Distributing Low-Volume Specimens in Asia Pacific Dorevitch PathologyHeidelberg Victoria Australia 2
  3. 3. Importance of Communication, Understanding and Experience• Communication and Understanding – Language – Culture – Regulations – Roadblocks• Experience 3
  4. 4. Asia Pacific Region Countries • Australia • Philippines • New Zealand • Singapore • Hong Kong • South Korea • India • Taiwan • Japan • Thailand • Malaysia • Vietnam 4
  5. 5. Study Set Up• Protocol review• Region specific requirements• Global Laboratory Specification Document (GLSD) – Agreed study specifications – Sign off by all parties 5
  6. 6. Pre-analytical Considerations• Documentation – region specific• Supplies• Investigator Site• Specimen Considerations• Transportation• Receipt at Central Laboratory 6
  7. 7. Documentation (1)• Region specific requirements – Sample Destruction Declaration (New Zealand) – Material Safety Data Sheets for supplies to Japan if not available in Japan• Assistance with information required for CTN – CTN obtained by sponsor 7
  8. 8. Documentation (2)• Import permit/customs declaration for kits and supplies – all kit components listed – to CRA for advance approval pre shipments• Restrictions with import of supplies to some countries (needles, alcohol swabs)• Import permit/customs declaration into Australia 8
  9. 9. Supplies• Requisition Forms• Kits – ACM Kit-Kaddy• Other supplies• Packaging• Investigator specific pre-printed air way bills 9
  10. 10. Investigator Site (1)• Training – Investigator Meeting – Site Initiation Visits• Support – Investigator Laboratory Manual and specific laminated summary charts – Email/phone support – Dangerous goods training (site personnel) 10
  11. 11. Investigator Site (2)• Correct requisition form and kit for visit• Specimen collection• Specimen preparation• Packaging – Frozen packaging materials and dry ice brought to site at pick up• Shipping 11
  12. 12. Specimen Considerations• Sample viability• Time• Temperature• Preservative• Sample agitation – CBC - disruption of red cells – Haemolysis of whole blood samples• Light sensitivity – ↓bilirubin, some vitamins 12
  13. 13. Transportation• Booking instructions• Last booking/call time• Last pick up time 13
  14. 14. Shipping Timetable - JapanLocation Last Call Time Last Pick-Up TimeTokyo 18:00 -1 (previous day) 13:00Kanagawa 18:00 – 1 (previous day) 13:00Kyoto 16:00 -1 (previous day) 10:30Fukuoka 16:00 -1 (previous day) 11:00Nagasaki 16:00 -1 (previous day) 10:30
  15. 15. Transportation• Booking instructions• Last booking/call time• Last pick up time• Transit Times• Monitoring – Tracking – Dry ice replenishment – Pre-alert 15
  16. 16. Sample Problems• Incorrect sample type• Insufficient sample• Thawed frozen samples• Frozen ambient samples• Lost samples• Impact - difficulty of collection under same conditions 16
  17. 17. Effect of Frozen Sample ThawingSerum Insulin (GTT) -20oC 4oC (48h)Fasting (RR: <12 mIU/L) 31 18One Hour 110 65Two Hour 54 33 17
  18. 18. Receipt at Laboratory• Specimen integrity – Sample type – Volume – Temperature• Consistency check – Tube labelling – Consistency of specimen labelling with requisition – Consistency of subject details with previous visits 18
  19. 19. Critical Factors• Communication• Cooperation• Knowledge• Teamwork• Traceability 19

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