1. « A Driver becomes Monitor » Philippe Van der Hofstadt B & C International, Belgium Conférence CEMO 14 Mars 2001

4. Working method 1. Initiation 2. Planning 3. Pick-up4. Delivery 5. Completion

5. 1. Initiation Collect site info for pick-up & delivery Confirm pick-up & delivery frequency Prepare study-specific transport protocol Sign transport protocol Prime the study database

6. Study-specific transport protocol Communication procedure Pick-up & delivery frequency Required transport documents Required data check on-site vs request form # samples/visit Patient demographics Collection date & time … Data cleaning procedure

7. 2. Planning Call sites to confirm sample availability Plan routes in routing software Book travel arrangements (hotel, shuttle, ferry,…) Confirm pick-up date & time to sites Confirm to Lab/Sponsor final pick-up schedule

8. 3. Pick-up Prepare materials Arrival on-site Scan bar-codes Data check Print pick-up note Upload data to office Download route from office

9. 4. Delivery Arrival on-site Deliver frozen samples Print delivery note Departure Upload data to office

10. 5. Completion Pick-up confirmation to Lab/Sponsor next morning Delivery confirmation to Lab/Sponsor next morning

13. Advantages Investigator No need to call Courier/Lab Scheduled pick-up date and time Dry ice delivered to site personnel Samples packed by driver No worry about sample shipment dates

14. Advantages Central Labs Pick-up schedule known in advance Daily pick-up confirmation Inconsistencies identified/corrected on- site Feedback from site non-compliance Sample tracking through lab barcode Increased interaction with sites e.g. expired kits «Training » from site personnel

15. Advantages Sponsor Improved service to Investigators Increased protocol compliance Additional site monitoring Feedback from site non-compliance

16. Future developments Consolidated clinical trial transport On-site training Bidirectional e-link Lab-Courier Automated data cleaning on-site On-site lab data entry