« A Driver becomes Monitor »

Philippe Van der HofstadtB & C International, Belgium

Conférence CEMO14 Mars 2001

Working method

1. Initiation

2. Planning

3. Pick-up 4. Delivery

5. Completion

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

Study-specific transport protocol

Communication procedurePick-up & delivery frequencyRequired transport documentsRequired data check on-site vs request form

# samples/visitPatient demographicsCollection date & time …

Data cleaning procedure

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

3. Pick-up

Prepare materialsArrival on-site

Scan bar-codes

Data check

Print pick-up note

Upload data to office

Download route from office

4. Delivery

Arrival on-site

Deliver frozen samples

Print delivery note

Departure

Upload data to office

5. Completion

Pick-up confirmation to Lab/Sponsor next morning

Delivery confirmation to Lab/Sponsor next morning

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

Advantages Central Labs

Pick-up schedule known in advanceDaily pick-up confirmationInconsistencies identified/corrected on-siteFeedback from site non-complianceSample tracking through lab barcodeIncreased interaction with sites e.g. expired kits«Training » from site personnel

Advantages Sponsor

Improved service to Investigators

Increased protocol compliance

Additional site monitoring

Feedback from site non-compliance

Future developments

Consolidated clinical trial transport

On-site training

Bidirectional e-link Lab-Courier

Automated data cleaning on-site

On-site lab data entry