Quest Diagnostics Clinical Trials Boehringer Ingelheim Protocol: BI 1230.14 Study ID: 6RX Toronto 23...

Quest DiagnosticsClinical Trials

Boehringer Ingelheim Protocol: BI 1230.14Study ID: 6RX

Toronto 23 February 2013

Investigator’s Meeting

Quest Diagnostics

General reminder

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 | 2

Central Review of Bone Marrow

- No assessment at end Cycle 1- Every other cycle- Relapse or progression- EOT

Quest Diagnostics

The Starter Pack

Starter Pack• 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


Quest Diagnostics


Each Kit Contains:1 x Ambient Shipper Carton2 x 95kPa Specimen Bags

2 x Absorbent Sleeves (Each Sleeve holds up to 6 Vials)

2 x Air Pillows

Initial Supply volume

1 BOX of “X-tra® Slides” (50 slides in each pack)

Shipment material

Block transport box biopsy provided in the initial starter pack.

15 “Slide mailer box”(use one box/ patient/ visit)

http://www.surgipath.com/us-en/downloads/ProductPhoto/6-large.jpg

Quest Diagnostics

General reminder


START

Is a bone marrow aspirate being

submitted ?

SUBMIT:* 3 unstained bone marrow aspirate smears* Results of CBC with differential and platelet counts* Pathology report

SUBMIT* Bone marrow biopsy (block or 4 unstained slides)* Results of CBC with differential and platelet counts* Pathology report

Yes

No (“dry tap”)

NOTES:A block is preferred and will be returned if requested. Unstained sections should be submitted on positively charged glass slides.A copy of the results for the Complete Blood Cell Count (CBC) should ideally be from the same day that the bone marrow aspirate is performed.Previously-stained diagnostic Wright-Giemsa smear(s) can be submitted in the event unstained aspirate smears are unavailable or inadequate.

BM assessment

Quest Diagnostics confidential information | 6

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.

Bone Marrow Aspirate (or Biopsy) Preparation


TISSUE SECTIONS ONPOSITIVELY CHARGEDFROSTED ENDED SLIDES

PLACE SLIDES INTO SLIDE BOX

SLIDE BOX

PLEASE REFER TO INSTRUCTIONSIN THE SPECIAL PROCEDURES

SECTION OF THIS MANUAL

COLLECT:

PREPARE:

SHIPMENT:

Bone Marrow Aspirate Preparation


EMBEDDED TUMOR TISSUE BLOCK

WRAP TISSUE BLOCK INFOAM WRAP POUCH ANDPLACE INTO SLIDE BOX

SLIDE BOX

PLEASE REFER TO INSTRUCTIONSIN THE SPECIAL PROCEDURES

SECTION OF THIS MANUAL

COLLECT:

PREPARE:

SHIPMENT :

Bone Marrow Biopsy Block Preparation


•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

PREPARATION OF BM ASPIRATE SLIDE

Investigator Manual


• 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.

PREPARATION OF PARAFFIN EMBEDDED TISSUE BLOCKS

Investigator Manual


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.

Quest Diagnostics confidential information | 12 | 12

Requisition Form – Demographic sectionYour account number and investigator information will be pre-printed

Complete this box with required demographic information at each visit.


Requisition Form – Testing section


Reporting

• No Quest results are to be provided to site.

• Central review of BM

C L I N I C A L T R I A L S C E N T R E

LABORATORY REPORT

PAT IENT NAM E PAT IENT ID RO OM NO . AG E SEX PHYSIC IAN

PAGE REQ UISIT IO N NO . ACCESSI ON N O. L AB REF . # CO LL ECT ION DATE & TI ME L OG -IN -DAT E REPO RT DAT E & T IM E

REMARKS

REPORT STATUS TEST UNITS REFERENCERANGE

SITECODEIN RANGE OUT OF RANGE

RESULT

TESTINGCTECRUE DU TILL UELB-13 32 GE NVAL

BELGIUM 84445 085 ROUTE: INT CT1 STOP

S- -E 9999 9 25 F

1 2504 15 10.02.2000 08:30 11.02.2000 11.02.2000 19:0 5

FINAL

8444 5085 250415 2

SB CL ST UDY ID: ABCPROT OCOL: 12345CENT RE#: 02BIRTHDAT E: 07.05.1 971VISIT NUMBER: MONTH 6VISIT TYPE: RET EST

BIOCHEMISTRY

BILIRUB IN, TOTALALKALINE PHOSPHATASEPROT EIN, TOTAL SERUMASAT ( SGOT)ALAT (SGPT )ALBUMINSODIUMPOTASSIUMCALCIUMCREATININEGLUCOSE

*1810079

48

3.92.301054.5

8082

**16 5

UMOL /LU/LG/LU/LU/LG/LMMOL/LMMOL/LMMOL/LUMOL /LMMOL/L

0-2220-1 2560-8 50-420-4832-5 0135- 1463.5-5.32.12-2.5644-1 243.9-6.4

HS

PAGE 2 OF 3

G1

D+

Quest Diagnostics

X

Room TemperatureQuest Courier Bag

Place specimensin front pouch.

Place requisition in rear pouchplacing bar code out.

Close Zip Lock firmly.

Mark transport temperatureusing permanent marker.

Store at room temperatureuntil picked up by Quest courier.

| 18 confidential information


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

Recommended maximum of two transport bags per box

Shipment from site to Quest

on monthly basis


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

belsack

would it be possible to have here the study specific document to avoid confusiion?


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:

www.questcentrallab.com/accreditations.html

Investigator Manual

Please review instructions before taking samples.


Client Response Center – USA & Canada

1-800-877-7004

Quest Diagnostics Clinical TrialsClient Response Centre

27027 Tourney Road, Ste 2EValencia 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.

Quest Diagnostics Clinical Trials Boehringer Ingelheim Protocol: BI 1230.14 Study ID: 6RX Toronto 23...

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