• Save
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
Upcoming SlideShare
Loading in...5
×
 

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

on

  • 611 views

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 ...

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.

Statistics

Views

Total Views
611
Views on SlideShare
611
Embed Views
0

Actions

Likes
0
Downloads
0
Comments
0

0 Embeds 0

No embeds

Accessibility

Upload Details

Uploaded via as Microsoft PowerPoint

Usage Rights

© All Rights Reserved

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Processing…
Post Comment
Edit your comment

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 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 Presentation Transcript

  • 1
  • Operational Best Practices for Handling and Distributing Low-Volume Specimens in Asia Pacific Dorevitch PathologyHeidelberg Victoria Australia 2
  • Importance of Communication, Understanding and Experience• Communication and Understanding – Language – Culture – Regulations – Roadblocks• Experience 3
  • Asia Pacific Region Countries • Australia • Philippines • New Zealand • Singapore • Hong Kong • South Korea • India • Taiwan • Japan • Thailand • Malaysia • Vietnam 4
  • Study Set Up• Protocol review• Region specific requirements• Global Laboratory Specification Document (GLSD) – Agreed study specifications – Sign off by all parties 5
  • Pre-analytical Considerations• Documentation – region specific• Supplies• Investigator Site• Specimen Considerations• Transportation• Receipt at Central Laboratory 6
  • 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
  • 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
  • Supplies• Requisition Forms• Kits – ACM Kit-Kaddy• Other supplies• Packaging• Investigator specific pre-printed air way bills 9
  • 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
  • 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
  • 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
  • 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) 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
  • Transportation• Booking instructions• Last booking/call time• Last pick up time• Transit Times• Monitoring – Tracking – Dry ice replenishment – Pre-alert 15
  • Sample Problems• Incorrect sample type• Insufficient sample• Thawed frozen samples• Frozen ambient samples• Lost samples• Impact - difficulty of collection under same conditions 16
  • Effect of Frozen Sample ThawingSerum Insulin (GTT) -20oC 4oC (48h)Fasting (RR: <12 mIU/L) 31 18One Hour 110 65Two Hour 54 33 17
  • 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
  • Critical Factors• Communication• Cooperation• Knowledge• Teamwork• Traceability 19