1. Quest Diagnostics Clinical Trials
Boehringer Ingelheim Protocol: BI
Study ID: 6RX
Toronto 23 February 2013
Investigator’s Meeting

2. √ Central Review of Bone Marrow No assessment at end Cycle 1
General reminder
Central Review of Bone Marrow
No assessment at end Cycle 1
Every other cycle
Relapse or progression
EOT
Protocol Specific Testing
Shipping Temp
Protocol Specific Visit(s) - visit names :
Screening
(diagnosis)
Cycle 2 Visit 5
Cycle 4 Visit 5
Every second cycle – Visit 5
Suspicion of relapse OR disease progression
EOT
Bone marrow aspirate
(biopsy)
Ambient √
confidential information

3. The Starter Pack Additional Supplies Visit Specific Kits
Includes all supplies needed for the trial
Site Specific
No Visit Specific Kits
No visit specific kits on this study.
All supplies to be provided in bulk.
Additional Supplies
Investigator Manual
Shipping instructions
Additional Study Specific Material
Visit Specific Kits
All supplies for visit & Site Specific Requisition Form
Kits are labeled by visit number;
Expiration date on label
Additional Supplies
Investigator Manual (English)
Shipping appendix
Transport Material & Documents
Additional Study Specific Material (Urine pregnancy kits, Urine dipsticks, Urine collection cups and lids)
confidential information

4. Block transport box biopsy provided in the initial starter pack.
Initial Supply volume
1 BOX of “X-tra® Slides”
(50 slides  in each pack)
15 “Slide mailer box”
(use one box/ patient/ visit)
Block transport box biopsy provided in the initial starter pack.
Shipment material
Each Kit Contains:
1 x Ambient Shipper Carton
2 x 95kPa Specimen Bags
2 x Absorbent Sleeves (Each Sleeve holds up to 6 Vials)
2 x Air Pillows
confidential information

5. General reminder
BM assessment
confidential information

6. Bone Marrow Aspirate (or Biopsy) Preparation
At each assessment, please ship:
3 unstained slides in case of BM aspirate smears,
OR 4 unstained slides in case of BM biopsies,
Complete Blood Count (CBC) with differential and platelet counts (ideally from the same day of BM),
And corresponding pathology reports for the submitted material.
The pathology report will be shipped in the local language with bone marrow slides and CBC report.
confidential information

7. Bone Marrow Aspirate Preparation
COLLECT:
PREPARE:
SHIPMENT:
confidential information

8. Bone Marrow Biopsy Block Preparation
COLLECT:
PREPARE:
SHIPMENT :
confidential information

9. Investigator Manual PREPARATION OF BM ASPIRATE SLIDE
Positively charged frosted ended slides must be used.
Section a single section containing tissue onto each slide; the thickness is 4-5 microns. Sections must be from the same tissue block.
Study ID, subject identifier, and block number must be written legibly in pencil on the frosted end of the slide.
Slides must not be baked or melted.
Cover slips must not be used.
Place slides in slide box and ensure all padding is included.
Affix the appropriate shipping label from requisition form to slide container. Ensure subject identifier, and block number are written clearly on the box label.
See packaging instruction
Investigator Manual
confidential information

10. Investigator Manual PREPARATION OF PARAFFIN EMBEDDED TISSUE BLOCKS
 Standard dimensions of block – approximately 4cm x3cm
If multiple blocks available, submit block with most tissue.
Do not send multiple blocks per subject visit.
The study ID, subject identifier and block number must be written on the block in pencil and be clearly legible.
Wrap blocks in a foam wrap pouch and place into slide container.
Affix the appropriate shipping label from requisition form to slide container. Ensure, subject identifier, and block number are written clearly on the box label.
See packaging instructions.
If a site requests to have a block returned, additional sections may be required to be cut prior to the block being returned.
Investigator Manual
confidential information

11. Requisition Forms White copy shipped with specimen
Yellow copy retained at site
Slides Labels:
Slides need to be identified with water resistant pen with patient ID & date. 
Then they are placed in the “slide mailer box” which is labeled with the label (Specific barcode) from the requisition that is completed (one box/ patient/ visit)
All labels are visit specific. Discard ALL unused labels.
Reminder: If samples are incorrectly labelled/not labelled, results may be delayed/tests may not be performed.
confidential information

12. Requisition Form – Demographic section
Your account number and investigator information will be pre-printed
Complete this box with required demographic information at each visit.
confidential information
| 12

13. Requisition Form – Testing section
confidential information

14. No Quest results are to be provided to site.
Reporting
No Quest results are to be provided to site.
Central review of BM
confidential information

15. Site Specific Information – U.S.A/Canada
confidential information

16. Copies can be found in the Investigator Manual
CUSTOMS DECLARATION:
1. Make three copies of the Customs Declaration on your letterhead paper (formal stationery). Important: When photocopying the Customs Declaration onto your letterhead, please be sure to include the protocol information at the bottom of the page (i.e., the document footer).
2. Print, in the following order, shipper’s name, c/o company name, address, and telephone number.
3. Indicate whether the contents are non-infectious or, if infectious, the name of the pathogen.
4. Indicate the total volume (mL) and/or quantity of specimens shipped.
5. Date and sign all three copies of the Customs Declaration in blue ink only.
6. Print your name and title next to your signature (a rubber stamp/seal may be used).
7. Write the airway bill number of the shipment on the form.
8. Add these forms to the shipping documents.
confidential information

17. Quest Diagnostics Courier Service
U.S.A Sites
Room Temperature X
You will receive a Logistics Account number from the Quest Distribution office
if you do not already have one.
This number recognizes your site for the Clinical Trials Central Laboratory.
Detailed information can be found on the Site Summary Information .
Call at least one day before pick up is needed.
Mark the baggie for Room Temperature ( X )
confidential information

18. X Room Temperature Quest Courier Bag Place specimens in front pouch.
Place requisition in rear pouch
placing bar code out.
Close Zip Lock firmly.
Mark transport temperature
using permanent marker.
Store at room temperature
until picked up by Quest courier. X
confidential information

19. Shipment from site to Quest on monthly basis
Ambient Shipment – Commercial Couriers
Transport material & documents included in your Starter Pack.
Place the specimen transport bag(s) on top of one air pillow
& place another air pillow on top of specimen transport bag(s)
Gel wraps should replace air pillows when outside
air temperature is below -10°C/14°F or above 34°C/93°F
Complete transport documents & call courier
Shipment from site to Quest
on monthly basis
Recommended maximum of two transport bags per box
confidential information

20. The Reorder Form
Use this form to re-order supplies
Please allow 5 working days for delivery (This may be more if local regulations require import licenses)
Indicate quantity here and fax to Quest Diagnostics
In order to reduce the number of shipments to your site, please order additional material for at least 2 months (no more than 3 months)
Please allow 5 working days for delivery (10 working days for countries requiring import licences)
Indicate quantity here and fax to Quest Diagnostics
A confirmation number will be faxed back to you.
Refer to this number if you have any questions regarding your re-supplies.
confidential information

21. Please review instructions before taking samples.
Investigator Manual
Investigator Manual
Contains all the information for collecting, preparing and shipping of specimens for this study.
Logistics & Quest Diagnostics Contact information can be found in the Shipping Appendix at the back of the Study Manual.
Lab Certification
For future updates of this certificate and accreditations, please visit our website:
Please review instructions before taking samples.
confidential information

22. Client Response Center – USA & Canada
Quest Diagnostics Clinical Trials
Client Response Centre
27027 Tourney Road, Ste 2E
Valencia CA 91355
Hours of operation for Client Response can be found in your Investigator Manual
Specific Instructions for contacting Quest Diagnostics from your country can be
found in the Appendix Section of the Laboratory Manual.
confidential information

23. Questions
confidential information
Confidential © Almac Group 2012