Covance Central Laboratory Services Manual Puma Biotechnology, Inc.

Covance Central
Laboratory
Services Manual
Indianapolis
8211 SciCor Drive
Indianapolis, IN
46214-2985 USA
Tel. (317) 271-1200
(local calls)
Fax: (317) 273-4030
Geneva
Rue Moïse-Marcinhes 7
1217 Meyrin/Genève-CH
Tel: +41 58-822-7000
Fax: +41 58-822-6999
Puma Biotechnology, Inc.
Protocol: PUMA-NER-1301
Covance Project Number: 514875
Manual Created: 22 March, 2013
Manual Revised: 01 May, 2013
Singapore
1 International Business
Park
#05-12A/B The Synergy
Singapore 609917
Tel. 65-6560-8793
Fax. 65-6565-5901
Covance Central Laboratory Services
© 2011 Covance CLS. All rights reserved.
http://www.covance.com/products/clinical/central-lab/certifications.php
Laboratory regulatory certifications available on Covance website
514875_TMEA
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Shanghai
1st Floor, No. 6 Building
151 Li Bing Rd
Zhangjiang Hi-Tech Park
Shanghai 201203
China
Tel: +86 21 51371111
Fax:+86 21 51371301
Tokyo
CB Lab
c/o BML General Laboratory
1361-1 Matoba
Kawagoe-shi
Saitama 350-1101 Japan
Japan Toll free: 0120-123-905
Direct line: 03-5159-3426
Fax: 03-5250-0360
TABLE OF CONTENTS
Schedule Visit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Section 1
Kit Information
Holiday Considerations/Customs Closures
Collect Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Section 2
Laboratory Visit Schedule
Analytes by Groups
Centrifuge Instructions
Specimen Collection Procedures
Draw Tube Adapter Procedures
Instructions for Completing Requisition Forms
Project Specific Requisition Forms
Pack and Ship . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Section 3
General Information
Courier Contact Numbers
Dangerous Goods Training Information
Packaging and Shipping of Samples
Resupply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Section 4
General Information - Supply/Resupply
Get Result. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Section 5
Reference Ranges/Alerts and Flags
Project Specific Reference Ranges and/or Alerts and Flags
Get Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Section 6
Covance CLS Customer Service Contact Numbers
Laboratory Certifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Section 7
Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Section 8
Archived Pages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Section 9
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Section 10
Disclaimer:
The Created Version Date and the Revised Version Date on the cover of the manual refer to either the original publication of the manual or the
customer requested changes to the protocol specific pages. The dates on the Covance standard pages are not necessarily representative
of the Revised Version Date, as the updates of these pages are due to Covance internal changes or regulatory changes, which can occur
at anytime.
English_TableOfContents_Update: 20130322
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©2011 Covance CLS
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1
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KIT INFORMATION
!
NOTE: To obtain the highest quality specimens possible, it is recommended all collection supplies
be stored between 4°C to 25°C (39°F to 77°F).
!
• Kits are protocol, investigator and visit speci c.
Select the correct kit accordingly.
• Please check kit expiration dates before
using the kit!
Some tubes used for the collection of samples
have expiration dates. These dates are defined
by tube manufacturers.
To ensure the validity of the tubes contained in
the collection kit, expiration dates are printed
on the outside of the kit box. The expiration
date of each kit corresponds to the shortest
expiration date of the tube(s) within the kit.
Please do not collect specimens in expired
containers!
Specimens received in an expired container
which includes an additive will be canceled
as: “Sample drawn in expired tube: Testing
not performed.”
If you have expired tubes please call Covance
CLS to have these kits replaced and your
inventory updated.
!
• A unique accession number is assigned to
each kit and its requisition form. Within the kit,
specimen containers and the requisition have
the same accession number (bar code).
Do not interchange the tubes and/or
requisition forms between kits!
!
• Complete the labels with appropriate identi ers
(screening number and/or patient number)
using a black ball point or indelible ink pen.
• Each container label is pre-printed with an
internal Covance code, which is to be its
primary source of identi cation.
Bulk Supplies
Depending on your protocol, additional items may be provided. For some studies, no bulk supply is provided.
Note:
Information about investigator performance in connection with the use and/or return of materials in any
laboratory test kit will be collected and used by Covance and/or its affiliates to help evaluate clinical
studies and to evaluate investigators for future clinical studies.
English_Kit Information_Update: 20110204
514875_TMEA
©2003 Covance CLS
Page: 4
CUSTOMS CLOSED/PUBLIC HOLIDAYS
!
Important considerations
Local courier service (pickup and delivery) may be limited prior to, during and following observed
holidays in the country to which you are shipping specimens. It is imperative that you check local
service schedules in advance of the holiday. Listed below are important considerations when
planning your patient visits during the holidays.
- Your courier service reserves the right to observe earlier than usual pick-up times during the holidays.
Call your courier service for local pick-up schedules.
- During the December/National holidays, schedule your pickups in advance of the holiday where
possible.
- Call early in the day to schedule your pickup.
- When a holiday is observed on Monday, avoid laboratory collections on the preceding Saturday (i.e.
Labor Day). (Not applicable to Japan)
- Frozen specimens should NOT be shipped on the day before the observed holiday. Send frozen
specimens on the next available business day. (Not applicable to Japan)
- If shipping specimens on Friday, mark airway bill for Saturday delivery. (Not applicable for Japan)
- Specimens with short stabilities (eg. lymphocyte subsets, reticulocyte counts, etc.) should not be
collected on the day prior to the holiday. (Not applicable to Japan)
- For sites with 24 hours delivery time to Covance, do not schedule any shipment 24 hours before one
of the dates on the next pages. (Not applicable for Japan)
- For sites with 48 hours delivery time to Covance, do not schedule any shipment 48 hours before one
of the dates on the next pages. (Not applicable for Japan)
Holiday reminders are also available on the Covance website:
http://www.covance.com/investigators/holidays.pdf
English_Custom Closed/Public Holidays 1/4_Update: 20110614
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©2010 Covance CLS
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CUSTOMS CLOSED/PUBLIC HOLIDAYS
CALENDAR
US, Canada, Puerto Rico and Latin America (specimens sent to Indianapolis)
2013
2014
1 January
27 May
4 July
2 September
28 November
29 November
25 December
1 January
26 May
4 July
1 September
27 November
28 November
25 December
1
1
2015
1
1
1 January
25 May
4 July 2
7 September
26 November
27 November
25 December
1
1
New Year’s Day
Memorial Day
Independence Day
Labor Day
Thanksgiving Day
Thanksgiving Day
Christmas Day
For sites in US and Canada
If you ship specimens on a Thursday that is a holiday in the United States, you should mark “Saturday
delivery” on the airway bills.
1
Limited operations within Covance this day due to Thanksgiving period.
2
July 4, 2015 (the legal public holiday for Independence Day), falls on a Saturday. For most Federal
employees, Friday, July 3, will be treated as a holiday for pay and leave purposes.
Europe, Middle East and Africa (specimens sent to Geneva)
2013
2014
2015
1 January
29 March
1 April
9 May
20 May
1 August
5 September
24 December
25 December
31 December
1 January
18 April
21 April
29 May
9 June
1 August
11 September
24 December
25 December
31 December
1 January
3 April
6 April
14 May
25 May
1 August
10 September
24 December
25 December
31 December
English_Custom Closed/Public Holidays 2/4_Update: 20130305
514875_TMEA
New Year’s Day
Good Friday
Easter Monday
Ascension Day
Whit Monday
Swiss National Day
Jeûne Genevois
Christmas Eve
Christmas Day
New Year’s Eve
©2010 Covance CLS
Page: 6
CUSTOMS CLOSED/PUBLIC HOLIDAYS
CALENDAR
Asia, Australia and New Zealand (specimens sent to Singapore)
2013
1 January
10 February *
11 February *
29 March
1 May
24 May
8 August
9 August
15 October
3 November **, ***
25 December
New Year’s Day
Chinese New Year
Chinese New Year
Good Friday
Labour Day
Vesak Day
Hari Raya Puasa
National Day
Hari Raya Haji
Deepavali
Christmas Day
* As Chinese New Year falls on Sunday 10 February 2013 and Monday 11 February 2013, the next day,
Tuesday 12 February 2013, will be a public holiday.
Taiwan Customs are closed on Saturday/Sunday.
** The following Monday will be a public holiday.
*** Subject to change
China (specimens sent to Shanghai)
2013
1 January - 3 January
9-15 February
4-6 April
29 April - 1 May
10-12 June
19-21 September
1-7 October
New Year’s Day1
Spring Festival2
Tomb Sweeping Day3
Labor Day4
Dragon Boat Festival5
Mid-Autumn Festival6
National Days7
1
January 05 (Saturday) and January 06 (Sunday) are adjusted as working day.
February 16 (Saturday) and February 17 (Sunday) are adjusted as working day
3
April 7 (Sunday) is adjusted as working day
4
April 27 (Saturday) and April 28 (Sunday) are adjusted as working day
5
June 8 (Saturday) and June 9 (Sunday) are adjusted as working day
6
September 22 (Sunday) is adjusted as working day
7
September 29 (Sunday) and October 12 (Saturday) are adjusted as working day
2
The courier may be ordered any calendar day of the year. However, as much as possible, please avoid
shipping samples on Saturdays and Sundays.
English_Custom Closed/Public Holidays 3/4_Update: 20130305
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©2010 Covance CLS
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CUSTOMS CLOSED/PUBLIC HOLIDAYS
CALENDAR
Japan (specimens sent to Tokyo)
2013
2014
1 January
14 January
11 February
20 March
29 April
3 May
4 May
5 May
15 July
16 September
23 September
14 October
3 November
23 November
23 December
1 January
13 January
11 February
21 March
29 April
3 May
4 May
5 May
21 July
15 September
23 September
13 October
3 November
23 November
23 December
New Year’s Day
Coming of age Day
National Foundation Day
Vernal Equinox
Showa Day
Constitution Memorial Day
Greenery Day
Children’s Day
Marine Day
Respect of the Aged Day
Autumnal Equinox
Sports Day
Culture Day
Labor Thanksgiving Day
Birthday of the Emperor
(1) With the exception of New Year Bank Holidays, if a holiday falls on a Sunday, the following day is
treated as a holiday instead.
(2) When there is a single day between two national holidays, it’s also taken as a holiday.
English_Custom Closed/Public Holidays 4/4_Update: 20121221
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©2010 Covance CLS
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2
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LABORATORY VISIT SCHEDULE FOR PROTOCOL
PUMA-NER-1301
Puma Biotechnology, Inc.
VISIT
OCCURRENCE
TEST GROUPS
Specimen Management
SM 1/ PK 6 Hr Post
SM 2/ PK 8 HR Post
Cycle 1/ Day 1
Cycle 1/ Day 15
Day 1
Day 15
X
X
X
X
X Required testing
PK samples to be collected on Cycle 1, Day 1 and Day 15 at 6 hours post-dose (+/- 20 minutes) and 8
hours post-dose (+/- 60 minutes) for Arm A only patients.
©2011 Covance CLS
English_Visit Test Schedule_Update: 20130322
514875_TMEA
Page: 10
ANALYTES BY GROUPS FOR PROTOCOL
PUMA-NER-1301
Puma Biotechnology, Inc.
SM 1/ PK 6 HR POST
PK Sample 6 HR
SM 2/ PK 8 HR POST
PK Sample 8 HR
English_Analytes By Groups_Update: 20130322
514875_TMEA
©2011 Covance CLS
Page: 11
CENTRIFUGE INSTRUCTIONS
Recommendations regarding the proper use of centrifuge:
Centrifuge operators should evaluate the size of collection tubes compared to the buckets that are used
in the centrifuge. Most centrifuges have different types of buckets available for purchase from the vendor.
Tubes requiring centrifugation must rest on the bottom of the bucket that is used. If a tube is short and does
not rest on the bottom of the bucket that is used, a spacer provided by the centrifuge vendor should be
inserted into the bucket. Alternatively, a different bucket which allows the tube to rest on the bottom should
be used. Warning: if the bottom of the tube does not rest on the bottom of the centrifuge bucket, the
cap may loosen or come off during centrifugation.
Equation for calculating the relative centrifugal force
Covance CLS recommends serum and plasma samples centrifuge at 1500 to 2000 x g for 15 minutes.
Any deviations to these recommendations will be listed on your laboratory requisitions.
F: gravitational force [g]
R: radius measured from the center of rotation to the bottom of tube in the rotor [cm]
F
N=
N: speed of the centrifuge rotor [rpm = rotation per minute]
0.00001118 ( R)
Example: with a radius of 10 cm and 1000 g the required speed is:
N= 2990 rpm
1000
N=
0.00001118 (10)
SCALE A
SCALE B
SCALE C
A
If the field and the radius are
known, the corresponding speed
can be determined.
To calculate RCF
RCF =
0.00001118 • r • N2
RCF =
relative centrifugal
field (gravities)
r
=
rotating radius
(centimeters)
N
=
rotating speed
(revolutions per min)
B
C
SPEED - REVOLUTIONS PER MINUTE
For example, if the rotating radius
is 10 cm and the speed is 3,000
rpm, the relative centrifugal field is
1,000 • g (gravity)
RELATIVE CENTRIFUGAL FORCE - GRAVITIES
ROTATING RADIUS - INCHES
ROTATING RADIUS - CENTIMETERS
Using the RCF Nomograph
To determine the relative centrifugal
field (RCF), place a straightedge
on the nomograph connecting the
known speed (rpm) and the known
rotating radius. The point at which
the straightedge intersects the RCF
axis is the field.
The distance measured from the rotor axis to the tip of the liquid inside the tubes at the greatest horizontal
distance from the rotor axis is the rotating tip radius. The radius is listed for your convenience in the speed
and force tables.
Rotating Axis
ROTATING RADIUS
ROTATING RADIUS
ANGLE ROTORS
HORIZONTAL ROTORS
©2008 Covance CLS
English_Centrifuge Instructions_Update: 20091002
514875_TMEA
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SPECIMEN COLLECTION PROCEDURES FOR PROTOCOL
PUMA-NER-1301
Puma Biotechnology, Inc.
PLASMA
SM 1/ PK 6 Hr Post
OR
SM 2/ PK 8 Hr Post
One 3 mL lavender top tube.
1. Record patient ID on the labels of all the tubes.
2. For each time point, using one 3 ml lavender-top K2 EDTA
vacutainer, collect blood sample using the evacuated
collection tubes. Fill tube completely.
3. After obtaining the blood sample, mix collection tube
thoroughly by gently inverting the collection tube at least 8 to
10 times.
4. Centrifuge at 1500-2000 x g for 15 minutes until cells and
plasma are well separated.
5. Use the pipette provided to equally transfer all the plasma into
2 appropriately labeled A & B vials.
6. *Freeze aliquots immediately at -70ºC or below.
7. After Day 15 samples are collected, ship patient’s A samples
(for both Days 1 and 15) to Covance on dry ice at next available
standard shipping day. Ship patient’s B aliquots separately on
subsequent day after first shipment.
*Note: If -70ºC freezer is not available, place aliquots on dry ice
immediately in separate shipping boxes and ship both A & B boxes
to Covance on day of collection or next available day.
*B
FROZEN
-70°C
SUBSEQUENT DAY
AFTER
FIRST SHIPMENT
©2011 Covance CLS
English_Specimen Collection Procedures_Update: 20130501
514875_TMEA
*A
FROZEN
-70°C
NEXT AVAILABLE
SHIPPING DAY
(AFTER DAY 15)
Page: 13
SINGLE USE NEEDLE PROTECTION DEVICE INSTRUCTIONS
INSTRUCTIONS FOR USE:
b
Holding both pink shield and
green cap, twist and remove
white cap.
While holding the needle
firmly, screw holder onto
needle until it fits securely.
a) Rotate pink safety shield
back toward the holder.
b) Twist and pull green needle
cap straight off.
Perform venipuncture
according to your facility’s
established procedures.
Immediately after removing
needle from vein, cover
needle by pushing pink safety
shield forward with thumb until
an audible click is heard. DO
NOT attempt to engage shield
by pressing against hard
surface.
DO NOT remove needle from
holder. Dispose of the needle
and holder as one unit into
nearest sharps container. DO
NOT REUSE.
IMPORTANT SAFETY TIPS
• DO NOT REUSE HOLDER
• Holder threads are designed to be used ONLY ONCE. Reuse of holder is
potentially unsafe and could result in serious injury or exposure to bloodborne
pathogens.
• Once holder has been attached to the needle, DO NOT UNWIND it to readjust, BD Vacutainer Systems
Preanalytical Solutions
or to change needles.
1 Becton Drive
• Dispose of needle and holder as a single unit.
Franklin Lakes, NJ 07417
BD, BD Logo and Eclipse are trademarks of Becton, Dickinson and Company. ©2002 BD.
English_Venipuncture Needle Protection Device_Update: 20050310
514875_TMEA
©2003 Covance CLS
Page: 14
INSTRUCTIONS FOR COMPLETING REQUISITION FORMS

Please complete all the required information with a black ball point pen. This information is required
for patient identification and result reporting.
Any errors or missing details with regard to patient demographics will cause a delay in the
reporting of the results until information is verified!
!
Send the white copy of the completed requisition form together with the relevant samples to Covance
Central Laboratory Services
Covance Central Laboratory Services, Inc.
8211 SciCor Dr.
Indianapolis, IN 46214-2985
Tel: 866.762.6209
«Bar_req»
Accession No.
«Requisition_n»
«Bar_req»
THE ACCESSION NUMBER IS
THE REFERENCE NUMBER
FOR COMMUNICATION WITH
COVANCE.
COMPLETE ALL BOXES IN THIS SECTION WITH BLACK BALL POINT
PEN. FAILURE TO COMPLETE ALL BOXES WILL DELAY REPORTS.
Patient Number
-
2-part
Covance
internal
use
ONLY
Employee Visa
Investigator : «Inv_n»
«Address_1»
«Address_2»
«Address_3»
«Address_4»
«Address_5»
«Address_6»
«Address_7»
-
Country #
Laboratory Requisition Form
Puma Biotechnology, Inc.
Page 1 of 2 Protocol: PUMA-NER-1301
1. Patient Number
Site #
Patient #
VISIT:
Cycle 1/ Day 1
Cycle 1/ Day 15
Site ID #
Check one box
Birthdate
Complete month field in English
(Example: 02 JUN 1968)
Sex
Collection Date
Day
Month
Male
Visit
Year
3. Sex (Check appropriate box)
Day
Month
Year
Complete month field in English
(Example: 01 JAN 2001)
Collection Time
24 Hour Clock
Ambient=
Samples Collected by
Name of the person collecting the samples/
Name and phone number of the person
completing the requisition
Full name in capital letters
Requisition Completed by
Frozen=
4. Specimen Collection Date
5. Specimen Collection Time
:
(Record Midnight as 23:59)
Tube Count
2. Birthdate
Female
Full name in capital letters
Phone number
Of the person completing the
requisition
Refrigerated=
PK Samples to be collected for Arm A patients only.
Slides=
Enter Patient Number on each A & B plasma aliquot tube label.
Validation
SM 1/ PK 6 Hr Post
(+/- 20 minutes)
Collection Date
DD/MMM/YYYY
Collection Time
(24H Clock)
Same as collection date and
time as entered for visit above.
Same as collection date and time
as entered for visit above.
Not Collected
SM 2/ PK 8 Hr Post
(+/- 60 minutes)
Collection date and time or check Not
Collected box
REQUIRED TESTING – refer to following page(s) or below for collection and shipping instructions
«Bar_req»
Comments:
Write your comments here
WHITE COPY-COVANCE
«Label_6»
1
514875
PINK COPY-INVESTIGATOR
ADDITIONAL TESTING IS NOT ALLOWED
PLEASE DO NOT RETURN EMPTY CONTAINERS TO COVANCE.
Lkn 130322
©2003 Covance CLS
English_Instructions for Completing Requisition Forms_Update: 20130501
514875_TMEA
«Bar_req»
Page: 15
Covance Central Laboratory Services, Inc.
8211 SciCor Dr.
Indianapolis, IN 46214-2985
Tel: 866.762.6209
«Bar_req»
Accession No.
«Requisition_n»
«Bar_req»
THE ACCESSION NUMBER IS
THE REFERENCE NUMBER
FOR COMMUNICATION WITH
COVANCE.
COMPLETE ALL BOXES IN THIS SECTION WITH BLACK BALL POINT
PEN. FAILURE TO COMPLETE ALL BOXES WILL DELAY REPORTS.
Patient Number
Laboratory Requisition Form
Puma Biotechnology, Inc.
Page 1 of 2 Protocol: PUMA-NER-1301
2-part
Covance
internal
use
ONLY
Employee Visa
Investigator : «Inv_n»
«Address_1»
«Address_2»
«Address_3»
«Address_4»
«Address_5»
«Address_6»
«Address_7»
-
Country #
Site #
Patient #
VISIT:
Cycle 1/ Day 1
Cycle 1/ Day 15
Site ID #
Check one box
Birthdate
Day
Month
Year
Complete month field in English
(Example: 02 JUN 1968)
Sex
Collection Date
Male
Female
Day
Month
Year
Complete month field in English
(Example: 01 JAN 2001)
Collection Time
24 Hour Clock
(Record Midnight as 23:59)
Tube Count
Ambient=
:
Samples Collected by
Full name in capital letters
Requisition Completed by
Frozen=
Full name in capital letters
Phone number
Of the person completing the
requisition
Refrigerated=
PK Samples to be collected for Arm A patients only.
Slides=
Enter Patient Number on each A & B plasma aliquot tube label.
Validation
SM 1/ PK 6 Hr Post
(+/- 20 minutes)
Collection Date
DD/MMM/YYYY
Collection Time
(24H Clock)
Same as collection date and
time as entered for visit above.
Same as collection date and time
as entered for visit above.
Not Collected
SM 2/ PK 8 Hr Post
(+/- 60 minutes)
REQUIRED TESTING – refer to following page(s) or below for collection and shipping instructions
«Bar_req»
514875_TMEA
Comments:
WHITE COPY-COVANCE
«Label_6»
1
514875
PINK COPY-INVESTIGATOR
ADDITIONAL TESTING IS NOT ALLOWED
PLEASE DO NOT RETURN EMPTY CONTAINERS TO COVANCE.
Page: 16
«Bar_req»
Lkn 130322
Covance Central Laboratory Services, Inc.
8211 SciCor Dr.
Indianapolis, IN 46214-2985
Tel: 866.762.6209
«Bar_req»
Accession No.
«Requisition_n»
THE ACCESSION NUMBER IS
THE REFERENCE NUMBER
FOR COMMUNICATION WITH
COVANCE.
«Bar_req»
Page 2 of 2
2-part
THE FOLLOWING REQUIRED SPECIMENS MUST BE SHIPPED FROZEN ON DRY ICE AS INDICATED:
SM 1/ PK 6 Hr Post - SM 2/ PK 8 Hr Post
One 3 mL lavender top tube.
1. Record patient ID on the labels of all the tubes.
2. For each time point, using one 3 ml lavender-top K2 EDTA vacutainer, collect blood sample using the evacuated collection
tubes. Fill tube completely.
3. After obtaining the blood sample, mix collection tube thoroughly by gently inverting the collection tube at least 8 to 10 times.
4. Centrifuge at 1500-2000 x g for 15 minutes until cells and plasma are well separated.
5. Use the pipette provided to equally transfer all the plasma into 2 appropriately labeled A & B vials.
6. *Freeze aliquots immediately at -70oC or below.
7. After Day 15 samples are collected, ship patient’s A samples (for both Days 1 and 15) to Covance on dry ice at next available
standard shipping day. Ship patient’s B aliquots separately on subsequent day after first shipment.
*Note: If -70oC freezer is not available, place aliquots on dry ice immediately in separate shipping boxes and ship both A & B
boxes to Covance on day of collection or next available day.
PLEASE CHECK THAT ALL PATIENT IDENTIFIERS ARE COMPLETE, CONSISTENT AND CORRECT, AND THAT
EACH CONTAINER HAS THE SAME ACCESSION NUMBER, WHEN PACKING SPECIMENS FOR SHIPMENT!
«Label_6»
No NCR
1
514875_TMEA
514875
«Bar_req»
Keep on file for your records. DO NOT return to Covance.
Page: 17
Lkn 130322
3
514875_TMEA
Page: 18
GENERAL INFORMATION FOR PACKAGING AND SHIPPING
!
Covance shipping material is designed in accordance with IATA regulations!
Consolidated Shipments: (All Countries except Japan)
For your convenience, shipping materials provided by Covance are not protocol specific. Please consolidate
sample shipments of like condition (ambient or frozen) to Covance whenever possible.
Courier Pick-up Information
Prior to shipping your first specimens, we recommend that you call the courier to define your site as a new
pickup location for shipments to Covance. This will facilitate the process when you are ready for your first
shipment. Covance will be billed directly for all transportation costs.
Please be sure to inquire about your local service schedules and the latest time of day that you can call to
arrange for a pick-up. Timely pick-ups will ensure samples are shipped within stability for testing. (Refer to
Stabilities for Analytes in Section 1 of this manual.)
While most samples are specified to be shipped day of collection, we realize there are times when circumstances do not permit this to occur.
• Late afternoon sample collection after last call-in or pick-up availability for courier service
• Dry ice may not be available the same day as frozen sample collection
• Pick-up is missed by courier service
In the event that samples cannot be shipped the day of collection, they should be stored under the condition
they are to be shipped. These samples should then be shipped to Covance CLS the very next day of
availability.
• AMBIENT samples should remain at ambient temperature – Do not refrigerate
• REFRIGERATED samples should remain between 2°C and 8°C
• FROZEN samples should remain frozen at the appropriate temperature
Refer to Stabilities for Analytes in Section 1 of this manual.
For Latin America, Australia, New Zealand and Asia (except Japan):
When contacting courier, also inquire about local export requirements.
Shipping boxes (Countries except Japan when BML takes care of the sample pick-up)
Containers must be securely packed in their shipping box. Please check by gently shaking the box after
packaging. If the containers are loose, repack the box by filling the empty spaces with paper.
Materials Safety Data Sheets
MSDS sheets for chemical products used in Covance studies may be accessed at the following website:
<http://www.dolphinmsdsviewer.com/Covance/login.htm> The website allows you to search for the MSDS
sheets by product name. Use the following code to enter the website: 102359
English_General Information for Packaging and Shipping_Update: 20110614
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©2010 Covance CLS
Page: 19
GEL PAK SAFETY TIPS
IMPORTANT: INSTRUCTIONS FOR USE
Please take the specimen collection bag and place
it on the Gel Pak.
WRAP the Gel Pak AROUND the specimen
collection bag.
CAUTION:
DO NOT put the specimen collection bag
INTO the Gel Pak!
DO NOT put the tubes DIRECTLY INTO
the Gel Pak!
English_GelPak Safety Tips_Update: 20100429
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©2010 Covance CLS
Page: 20
PACKAGING PROCEDURES - CONSOLIDATING SHIPMENTS
AMBIENT, REFRIGERATED OR FROZEN
BIOLOGICAL SUBSTANCE, CATEGORY B
Notify your courier of your shipment!
Problems/questions concerning packaging procedures? Contact Covance using our toll-free number.
When possible, please consolidate shipments
!
Consolidating your sample shipments is a way to save you and your staff time by
reducing the number of shipping cartons prepared for shipment to Covance. Your
sponsor also benefits by reduced transportation cost for protocols.
Send samples for more than one patient and/or more than one sponsor or
protocol in a single shipment.
However, please always ship an individual patient’s primary (A) and backup
(B) samples in separate shipments.
NOTE: Actual shipping cartons
may differ from pictures
shown here.
Key points:
1. Always consolidate patient sample shipments by condition: ambient, refrigerated, or frozen.
2. Be sure each patient’s samples and the completed requisition for that patient are packaged together in their own
Specimen Collection Bag, by shipping condition.
3. The Ambient shipping box will hold 2 to 4 lab kits containing ambient samples.
4. The Frozen shipping box will hold 1 to 2 Specimen Collection Bags of samples per frozen shipment.
5. Be sure to allow ample space for dry ice in your frozen shipments as you will need 3 kgs of dry ice per shipment
(2 Kg for North America) when using Covance supplied packaging. Use of courier supplied packaging may require
more dry ice. Please follow your courier recommendation for the amount of dry ice to use.
6. Use the appropriate air waybill depending on sample condition (ambient/refrigerated or frozen).
EXAMPLE OF CONSOLIDATED SHIPMENT
Sponsor #1
Sponsor #3
Sponsor #2
Note: Contact Covance to inquire about special packaging designed to send large numbers of
samples per shipment if you are participating in a study with high daily patient volume.
©2012 Covance CLS
English_Packaging Procedure Consolidated Shipments_Update: 20130501
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COURIER CONTACT NUMBERS
Q
United States
UPS
(866) 961-3790
Federal Express
(800) 463-3339 (Domestic)
World Courier
(800) 221-6600
Canada
Federal Express
(800) 247-4747 (International)
World Courier
(800) 387-3381
Puerto Rico
Federal Express
(787) 793-9300
Japan
World Courier
81 3 3537-1080
NOTE:
It is important to utilize the special 866 number when contacting UPS to schedule pick-ups. This is a special
number for Covance sites only. Scheduling pickups via their automated system or on the
Internet will circumvent all of the special procedures Covance has in place with UPS and
increase the chances of a missed pickup.
Alaska and Hawaii Sites Note: Covance Central Laboratory Services’ Logistics Department will track all
shipments. Shipments should only be made Monday through Thursday with Thursday shipments marked for
Saturday delivery.
©2003 Covance CLS
English_US Courier Contact Numbers_Update: 20100518
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DANGEROUS GOODS TRAINING REQUIREMENTS
The investigator site is responsible for ensuring their staff is properly trained per their national regulations.
The changes to current regulations should be considered when assessing how training of staff fits into your
risk management program.
Dry Ice and other Dangerous Goods:
It is necessary for all individuals involved in the preparation or transport of dangerous goods to be properly
trained and tested initially, with follow-up training every 24 months. Additional training updates are required
any time the applicable regulations change.
• Function speci c training for preparing and shipping frozen samples on dry ice is a requirement.
• Some chemical xatives and UN2814 Category A Infectious substances require a more traditional training
program to ensure compliance with national and international rule making governing the packing and
shipping of these substances.
UN3373 Biological Substance, Category B (formerly known as Diagnostic specimens):
Biological Substance, Category B are specimens being transported for “investigational purposes”. Effective 01
January 2005, training requirements for persons responsible for packing and shipping Biological Substance,
Category B, UN3373, has been redefined in the International Civil Aviation Organization (ICAO) Technical
Instructions as well as the International Air Transport Association (IATA) dangerous goods regulations.
• Comprehensive formal training normally associated with other dangerous goods has been eliminated and
replaced with the requirement for the shipper to be “familiar” with the speci c regulations pertaining to
packing and shipping of Biological Substances, Category B.
Covance recommends that investigator sites provide some form of familiarization training to their staff for the
preparation and shipping of UN3373 Biological Substance, Category B. We also recommend establishing a
record of your staff’s training and date of the instruction.
List of Dangerous Goods training programs
The following is a list of several available training programs. Covance does not advocate or endorse one
particular program. This is not an all-inclusive list.
DGI Training Center
800-338-2291
DGItraining.com
Provides IATA Certified Air Seminars and online courses
IATA Training Schools
North America 1(514)390-6726
Europe, Africa, & Middle East 41 (22) 799 2751
Asia, Australia & the Pacific 65 239 7232
www.iata.org
Training schools located in 30 countries
Saf-T Pak Inc.
www.saftpak.com
Provides dangerous goods training via CD
or on-site instruction for North America and Europe
Airconsult
e-mail: [email protected]
www.airconsult-bf.com
Bureau of Dangerous Goods LTD.,TIANJIN
Addr.: No.3 Yingshui road, Nankai district, Tianjin China
Tel: 022-23495890 83326960 83326854 / Fax: 022-83326959
Email: [email protected]
www.bdg-china.com.cn
The training records must be made available upon request by the appropriate national authority.
US sites: Additional information from the Department of Transportation (DOT) can be found on their website,
http://hazmat.dot.gov
English_Dangerous Goods Training Requirements_Update: 20090724
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©2005 Covance CLS
Page: 23
PACKAGING PROCEDURES - ALL COUNTRIES
FROZEN
BIOLOGICAL SUBSTANCE, CATEGORY B
!
Ship no more than 120 mL in a Specimen Collection bag and no more than two Specimen
Collection bags per 2.0 kilograms of dry ice!
1. Insert the tube(s)
into the 2. Fold the white copy of the 3. Fill half of the styrofoam
Specimen
Collection
Bag
completed requisition form and
container with dry ice and
containing an absorbent pack.
place it into the pocket on the
insert the Specimen Collection
Place bag on at surface to
reverse side of the Specimen
Bag(s). Then ll the container
minimize wrinkles, especially at
Collection Bag. The bar code
using at least 2.0 kg dry ice.
adhesive sealing area. Remove
must be visible.
tape liner to expose adhesive.
Fold along bag opening so star
is inside of box shape. Press
from center to edge to seal.
!
Note: We recommend that
you ship no more than two
Specimen Collection bags
per 2.0 kilograms of dry ice.
4. Replace the styrofoam lid.
Continued on next page...
Notify your courier of your shipment!
Problems/questions concerning packaging procedures? Call us using our toll-free number.
English_Packaging Procedure Frozen Specimen_Update: 20110218
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©2003 Covance CLS
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PACKAGING PROCEDURES - ALL COUNTRIES
FROZEN
BIOLOGICAL SUBSTANCE, CATEGORY B
...continued from previous page.
NOTE: Actual shipping cartons
may differ from pictures
shown here.
5. Seal the shipping carton securely. Af x the 6. US domestic shipments: Complete and af x the
label with your address on the box as indicated
shipping document to the designated spot on the box.
on the picture above.
Rest of world: Insert the shipping documentation into
Note: Your shipment may be delayed if the
the transparent pouch ensuring that the airway bill
label is not affixed to the box.
remains visible. Affix the pouch to the cardboard box
on the “Shipping documents” section.
English_Packaging Procedure Frozen Specimen_Update: 20110218
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©2003 Covance CLS
Page: 25
SHIPPING DOCUMENTS
ARE PROVIDED IN LARGE COLOR-CODED ENVELOPES
!
The protocol specific shipping documents are provided in the appropriate envelope with the start-up
material. They are not automatically resupplied.
Order additional envelopes by using the web address/link http://www.covance.com/kitordering or by
contacting Covance CLS.
The envelope with text in RED
contains your shipping documents
for ambient, refrigerated or combo
ambient-refrigerated specimens.
The envelope with text in BLUE
contains your shipping documents
for frozen or combo ambient-frozen
specimens.
The envelope with
text in GREEN
contains your shipping
documents for
miscellaneous
(including any special
shipping documents
not included in the
two other envelopes)
and/or dangerous
goods specimens
English_Shipping Documents_Update: 20120605
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©2003 Covance CLS
Page: 26
SHIPPING DOCUMENTS - USA
ALL TEMPERATURES
Biological Substance Category B
NOTE:
The special routing address will allow UPS to provide the highest level of security
throughout their network to help ensure the safety and stability of your samples.
Special
Routing
Address for
Covance
Shipments
e
l
p
m
a
x
E
•
•
The same label will be used for all temperature conditions of samples.
Remove adhesive backing from shipping label and affix label to Covance package
Call UPS at 1-866-961-3790 to schedule your pick-up. Inform the UPS Call Center Representative that your
package is an URGENT COVANCE MEDICAL SHIPMENT.
If you have questions about shipping your package, or need help with any courier related issue, please contact
the Covance Site Support Services team at 1-866-762-6209.
English_US Shipping Documents UPS_Update: 20110324
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©2008 Covance CLS
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SUPPLY/NO AUTOMATIC RESUPPLY
!
Resupply
There is no automatic resupply for this study. All material (kits, shipping material and documents,
bulk supplies, etc...) needed for the laboratory visits must be ordered using the Web Resupply form.
There is no supply of shipping boxes for Israel and Africa. Investigators in these countries are requested to
order boxes from their couriers each time they request a pick-up.
To request additional supplies, please contact the appropriate Kit Inventory Center listed below:
For sites in US, Canada, Puerto Rico & Latin America contact Kit Inventory Center in Indianapolis
Web Resupply: http://www.covance.com/kitordering
E-mail: [email protected]
Phone: Please refer to Section 6 (Toll Free Contact Numbers) of this Covance Central Laboratory Manual.
All supply orders need to be ordered by 12:00 p.m. local time in order to be processed. Orders received after
12:00 p.m. local time will be processed the following business day (Monday - Friday)
Reminder for Latin America: Please request all supplies 20 business days prior to the next scheduled
visit to allow for production, shipment, and customs clearance. Supply delivery cannot be guaranteed for
shipments with a turn around time < than 20 business days.
For sites in Europe, Middle East and Africa contact Kit Inventory Center in Geneva
Web Resupply: http://www.covance.com/kitordering
E-mail: [email protected]
Phone: Please refer to Section 6 (Toll Free Contact Numbers) of this Covance Central Laboratory Manual.
For sites in Asia Pacific, Australia and New Zealand contact Kit Inventory Center in Singapore
Web Resupply: http://www.covance.com/kitordering
Email: [email protected]
Phone: Please refer to Section 6 (Toll Free Contact Numbers) of this Covance Central Laboratory Manual.
For sites in China contact Kit Inventory Center in Singapore
Web Resupply: http://www.covance.com/kitordering
Email: [email protected]
Phone: Please refer to Section 6 (Toll Free Contact Numbers) of this Covance Central Laboratory Manual.
Reminder for China: Please request all supplies 22 business days prior to the next scheduled visit to allow
for production, shipment, and customs clearance. Supply delivery cannot be guarantee for shipments with a
turn around time < than 22 business days.
For sites in Japan contact Kit Inventory Center in Singapore
Web Resupply: http://www.covance.com/kitordering
Email: [email protected]
Phone: Please refer to Section 6 (Toll Free Contact Numbers) of this Covance Central Laboratory Manual.
Reminder for Japan: Allow 10 business days for delivery. Allow 20 business days for delivery for kit
customization.
All supply orders need to be ordered by 12:00 p.m. local time in order to be processed. Orders received
after 12:00 p.m. local time will be processed the following business day (Monday - Friday)
Refer to your Web resupply form for delivery days.
Please note there will be an expedited fee for orders requested with less than the standard turn
around time.
Reminder: If you are located in an extended delivery area your delivery may take longer than the
standard turn around time.
English_Supply/No Automatic Resupply_Update: 20110901
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©2003 Covance CLS
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REFERENCE RANGES/ALERTS AND FLAGS
There are no reference ranges/alerts and flags for this project.
English_No Reference Ranges/Alerts and Flags_Update: 20030624
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©2003 Covance CLS
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6
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CONTACT NUMBERS TO CALL COVANCE CLS
To call Covance CLS in Indianapolis from:
Japan
1-317-271-1200
US, Canada, Puerto Rico
866-762-6209 (Toll Free)
317-271-1200 (Local calls)
317-616-2362 (Fax)
Latin America
317-271-1200 ext. 2008 (Collect call)
317-616-2366 (Fax)
Argentina (ALA)
0800-288-5288 (Toll Free)
Argentina (Telecom)
0800-555-4288 (Toll Free)
Argentina (Telefonica)
0800-222-1288 (Toll Free)
Brazil
0800-891-2507 (Direct)
or 0800-890-0288 (Toll Free)
or 0800-8888-288 (Toll Free)
plus 800-476-7136
plus 800-476-7136
Chile (Entel)
800-360-312 (Toll Free)
Chile (AT&T)
800-225-288 (Toll Free)
Chile (Telefonica)
800-800-288 (Toll Free)
Colombia
01-800-912-0075 (Direct)
or 01-800-911-0010 (Toll Free)
plus 800-476-7136
0-800-011-0870 (Direct)
or 0-800-0-114-114 (Toll Free)
plus 800-476-7136
Costa Rica
Dominican Republic
1-800-872-2881 (Toll Free)
Ecuador (Andinatel)
999-119 (Toll Free)
Ecuador (Pacifictel)
1-800-225-528 (Toll Free)
El Salvador
800-1288 (Toll Free)
Guatemala
99-99-190 (Toll Free)
or 138-126 (Toll Free)
Honduras
800-0-123 (Toll Free)
Mexico
001-800-476-7136 (Direct)
or 01-800-288-2872 (Toll Free)
Panama
800-0109 (Toll Free)
Peru (Telephonica)
0-800-50288 (Toll Free)
Uruguay
000-411-008-5447 (Direct)
or 000-410 (Toll Free)
Venezuela
0-800-2255-288 (Toll Free)
plus 800-476-7136
plus 800-476-7136
plus 800-476-7136
plus 800-476-7136
English_Covance CLS Contact Numbers 1/4_Update: 20110927
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©2003 Covance CLS
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CONTACT NUMBERS TO CALL COVANCE CLS
To call Covance CLS in Geneva from:
Monday - Friday: 8h00 - 19h00 (Geneva time = GMT +1)
Saturday:
10h00 - 17h00 (Geneva time = GMT +1)
If you need urgent assistance outside of Geneva working hours you may call
the Investigator Call Center in Indianapolis at +1 317 271 1200 (then press 2)
Austria
Belgium
Bulgaria
Cyprus
Denmark
France
Germany
Hungary
Ireland
Israel
Italy
Liechtenstein
Luxemburg
Netherlands
Norway
Portugal
Slovakia
Slovenia
Spain
Sweden
Switzerland
United Kingdom
+ 800 88 77 44 11 (Tel)
+ 800 88 77 44 22 (Fax)
Croatia
0800 22 30 61 (Tel)
0800 22 30 60 (Fax)
Czech Republic
800 142 083 (Tel)
800 142 787 (Fax)
Finland
990 800 88 77 44 11 (Tel)
990 800 88 77 44 22 (Fax)
Greece
00 800 4112 871 141 (Tel)
00 800 4112 871 140 (Fax)
Latvia
800 031 43 (Tel)
800 031 01 (Fax)
Lithuania
8800 30124 (Tel)
8800 30262 (Fax)
Monaco
800 93 185 (Tel)
800 93 184 (Fax)
Poland
00 800 41 11 231 (Tel)
00 800 41 11 230 (Fax)
Romania
08008 9 52 14 (Tel)
08008 9 52 13 (Fax)
Russia
810 800 201 71041 (Tel)
810 800 201 81041 (Fax)
Ukraine
0800504643 (Tel)
0800504642 (Fax)
South Africa
+ 800 88 77 44 11 (Tel)
+ 800 88 77 44 22 (Fax)
Turkey
00 800 419 871 141 (Tel)
00 800 419 871 140 (Fax)
For countries without a toll free line, please call your local telephone
operator and ask for a collect call to one of the below numbers:
English
French
German
Italian
Spanish
+41 58 822
+41 58 822
+41 58 822
+41 58 822
+41 58 822
Fax
+41 58 822 7521
English_Covance CLS Contact Numbers 2/4_Update: 20120323
514875_TMEA
7901
7902
7903
7904
7905
©2003 Covance CLS
Page: 34
CONTACT NUMBERS TO CALL COVANCE CLS
To call Covance CLS in Singapore from:
Australia
1800052134 (Toll Free)
(65) 6560-8793 (Tel)
(65) 6565-5901 (Fax)
Hong Kong
800 90 0792 (Toll Free)
(65) 6560-8793 (Tel)
(65) 6565-5901 (Fax)
India
0008006501323
Indonesia
001803 657 617 (Toll Free)
(65) 6560-8793 (Tel)
(65) 6565-5901 (Fax)
Malaysia
1800 801 842 (Toll Free)
(65) 6560-8793 (Tel)
(65) 6565-5901 (Fax)
New Zealand
0800440527 (Toll Free)
(65) 6560-8793 (Tel)
(65) 6565-5901 (Fax)
Pakistan
00 800 11065 (Toll Free)
(65) 6560-8793 (Tel)
(65) 6565-5901 (Fax)
From Pakistan, dial the Singapore direct toll-free no.
(00 800 11065). At the voice prompt, enter ‘2’ for
International Toll-Free service. Enter the telephone no.
65608793. Call will be connected.
Philippines
1800 1651 0312 (Toll Free)
(65) 6560-8793 (Tel)
(65) 6565-5901 (Fax)
Singapore
6560-8793 (Tel)
6565-5901(Fax)
South Korea
00 308 651 1353 (Toll Free)
(65) 6560-8793 (Tel)
(65) 6565-5901(Fax)
English_Covance CLS Contact Numbers 3/4_Update: 20110927
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©2003 Covance CLS
Page: 35
CONTACT NUMBERS TO CALL COVANCE CLS
To call Covance CLS in Singapore from:
Taiwan
0080 165 1493 (Toll Free)
(65) 6560-8793 (Tel)
(65) 6565-5901 (Fax)
Thailand
001 800 65 6350 (Toll Free)
(65) 6560-8793 (Tel)
(65) 6565-5901 (Fax)
Vietnam
(65) 6560-8793 (Tel)
(65) 6565-5901 (Fax)
To call Covance CLS in Shanghai from:
China
800 820 85 92 (Toll Free)
Note: When calling by mobile phone, please use
the direct telephone line below:
+86 21 51371141 (Direct Tel Line)
+86 21 51371304 (Fax)
To call Covance CLS in Tokyo from:
Japan
0120-123-905 (Toll Free)
+81-3-5159-3426 (Direct Tel Line)
+81-3-5250-0360 (Fax)
English_Covance CLS Contact Numbers 4/4_Update: 20110502
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Current CAP certifications available at: http://www.covance.com/products/clinical/central-lab/certifications.php
©2003 Covance CLS
US Laboratory Certifications 1/5_Update: 20120410
514875_TMEA
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Current CAP certifications available at: http://www.covance.com/products/clinical/central-lab/certifications.php
©2003 Covance CLS
US Laboratory Certifications 2/5_Update: 20130418
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©2003 Covance CLS
US Laboratory Certifications 3/5_Update: 20130409
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©2003 Covance CLS
US Laboratory Certifications 4/5_Update: 20130409
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©2003 Covance CLS
US Laboratory Certifications 5/5_Update: 20130409
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8
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GLOSSARY
Ambient: room temperature.
Analyte: a substance or chemical constituent of any body fluid that is analyzed.
Analyte Specific Reagents (ASR): This test was developed and its performance characteristics determined
by Covance Central Laboratory Services. It has not been cleared or approved by the U. S. Food and Drug
Administration. The FDA has determined that such clearance or approval is not necessary. Covance CLS is
certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88) as qualified to perform high
complexity clinical laboratory testing.
Blinding: some protocols require that the results of one or more laboratory tests performed at Covance CLS
are kept blinded when, for example, a certain value could give an indication of which treatment the patient is
receiving. The results are therefore not communicated to the investigator or sponsor during the course of the
study.
Centrifuge: an apparatus used to separate particles in suspension by centrifugal force. Processing a blood
specimen in a centrifuge will separate serum or plasma from blood cells. Centrifuge for 15 minutes at 1500
to 2000 x g to separate the blood specimen. Please consult your protocol for special specimen collection
procedures that require centrifugation at higher speed.
Clotted blood: results cannot be reported from such a specimen. This cancellation refers to small blood clots
consisting of RBCs, WBCs, platelets and clotting factors which alter the proportions of cellular and soluble
elements remaining in the specimen.
Consumed in testing: this phrase is used when the entire volume of specimen is used for testing, yet a
valid result is not obtained. Typically, this occurs when a small amount of specimen is originally received, or a
questionable result is obtained and insufficient volume is available to repeat the test.
Covance Central Laboratory Services reference ranges: individualized test reference ranges established
specifically for pharmaceutical clinical trial patients. They may be age and sex specific.
Delta: a flag alert indicating that a laboratory result represents a statistically significant change from the patient’s
baseline value; +d is the designation if the result is a positive change from baseline, -d is the designation if the
result is a negative change from baseline or pre-drug level. These flags appear to the left of the result on the
laboratory report. These results are not telephoned to the investigator or sponsor.
Dye interference: a phrase used when the color of the urine is such that the dipstick chemistry tests are unable
to be read.
Error in specimen identification: this indicates that the accession number and/or the patient identifier written
on the container does not match the accession number and/or the patient identifier written on the requisition
form.
Exclusion flags: EX is used to indicate an exclusion value according to the exclusion criteria set by the sponsor
according to protocol requirements. This flag will appear to the left of the result on the laboratory report.
Frozen: this term indicates the specimen was properly maintained in a frozen state, preferably below -20 °C.
English_Glossary 1/3_Update: 20091113
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GLOSSARY (CONTINUED)
Frozen specimens require dry ice to maintain a frozen state during shipment. Avoid a frost-free refrigerator
during storage of specimens. Please consult your investigator manual for proper storage instructions.
Hemolysis: indicates the rupture of red cells with release of hemoglobin and other analytes into the specimen.
Hemolysis will interfere with the performance of particular tests, which will result in specific cancellations.
High and Low flags: H for high and L for low flags appear to the right of the test result on the laboratory report
if the result falls outside the reference range. High and low results are not telephoned to the investigator or
sponsor.
Improper ratio of blood to anticoagulant: this is the result of the lavender or blue top tube not being filled
completely during collection, causing inconsistent results.
Incorrect specimen type: this phrase indicates that an incorrect specimen type was submitted, based on
protocol testing requirements, (e.g. serum received when plasma is required or vice versa, urine is received
for serum, etc.)
Invalid: in terms of calculations, an “invalid” comment would indicate that one component of the calculation
renders the calculation of a meaningful result impossible. Can also be used when the result is not reasonable
due to specimen irregularities; used when one component of a calculation is out of stability. Example: MCV,
MCHC and HCT resulted as invalid if specimen is greater than 60 hours old.
Investigational use only (IUO): the manufacturer of the reagent has informed us the performance
characteristics of this assay have not been fully established as required by the Food and Drug Administration
(FDA) regulations as outlined in 21 CFR (Code of Federal Regulations) 809 (In Vitro Diagnostic Products For
Human Use). Accordingly, test results for this assay may not presently be used as a diagnostic tool alone,
without confirmation by another medically established procedure.
Lipemic: serum or plasma with a turbid or milky appearance. This is caused by an elevation in triglycerides
and may be seen in a nonfasting specimen or in certain disorders of lipid metabolism. Lipemia will interfere
with several laboratory tests.
Microclots: “Microclots” may be reported for the platelet count when a valid count cannot be obtained due to
platelet clumping. Please consult your investigator manual for proper mixing instructions.
Myeloperoxidase deficiency: a common inherited disorder of neutrophil function. It is detected when using an
automated hematology instrument which performs a white blood cell differential using a peroxidase channel.
Patients rarely know they have the disorder and usually require no treatment. Myeloperoxidase deficiency can
also be acquired and is mostly seen in acute myelogenous leukemia, myelodysplastic syndrome and Batten’s
disease.
Panic alerts: HP for a high panic or LP for a low panic alert. They are associated with critical laboratory values
which may indicate medical emergencies. These flags appear to the right of the test result on the laboratory
report. These values are telephoned immediately to the investigator and confirmation of receipt for these
critical results must be obtained.
Pharmacokinetics: the study of the action of drugs within the body, including the routes and mechanisms of
absorption, distribution, excretion, and metabolism; onset of action; duration of effect; biotransformation; effects
and routes of excretion of the metabolites of the drug; rate of appearance and disappearance in blood, urine
or other body tissues.
Plasma: the fluid portion of the blood in which blood cells are suspended. This yellowish fluid separates from
a blood specimen which was mixed with an anticoagulant (e.g. EDTA, heparin, citrate or other anticoagulants)
upon centrifugation.
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GLOSSARY (CONTINUED)
Prolonged cell contact: the condition which occurs when a serum is allowed to remain in contact with cells for
a prolonged period of time. This may occur at the investigator site prior to centrifugation or may be due to red
blood cells present in the serum or plasma during transport. A combination of cellular metabolism and cellular
damage produces a pronounced decrease in serum glucose and elevations in potassium and phosphorus.
Quantity not sufficient: this phrase is used when an insufficient sample volume is received for testing.
Refrigeration during collection: This phrase means the specimen must be 2-8°C during the entire collection
procedure, (e.g. 24 hour urine collection). Please consult your specific collection instructions.
Repeat reactive (positive), confirmed: screening testing indicates specimen was positive; confirmation by a
more specific test also indicates that the specimen was positive. Specimen result is positive for the analyte.
Repeat reactive (positive), unconfirmed: screening testing indicates specimen was positive; however,
specific confirmation testing was not positive. Results are indeterminate. Recollection may be requested.
Sample drawn in expired tube: specimen received in expired container - Due to regulatory requirements,
Covance cannot report results from collection containers that are past the expiration date placed on the
container from the manufacturer. Results from expired containers will be cancelled.
Serum: the clear fluid portion of the blood obtained after the cells have formed a clot and the specimen is
centrifuged. This clear, straw-colored liquid portion of the blood does not contain fibrinogen or blood cells.
Sample is collected in a tube which does not contain an anticoagulant.
Short draw collection tubes: Covance is providing short draw collection tubes for this study. The short draw
Vacutainer brand tubes with Hemogard Closure are designed for collecting a small volume of blood. The short
draw tubes are the same size as adult size vacutainer tubes but contain only enough vacuum to fill the tube to
the indicator line. Short draw tubes fill more slowly than full volume tubes due to a lower vacuum.
Specimen received ambient: this phrase is used when a specimen intended for refrigerated or frozen shipment
is received at Covance Central Laboratory Services not in required shipping condition. Reasons include: Dry ice
evaporated, too little dry ice used, incorrectly packaged for frozen shipment, shipment delayed, etc.
Specimen received beyond stability: this indicates too much time has elapsed to perform a valid assay when
the specimen is received at Covance Central Laboratory Services. The test will be cancelled if the specimen
is received beyond the established stability period for a given analyte. It can also indicate that the specimen
should have been received frozen but was received ambient and the test will be cancelled as received beyond
stability since the ambient stability has expired.
Telephone alerts: HT for a high telephone alert or LT for a low telephone alert. They are associated with
laboratory values which may indicate clinical problems and need critical evaluation by the investigator. Covance
CLS standard is that these values are faxed to the investigator site.
TNTC: Too Numerous To Count. Too many cells to be counted under high power field microscopy. For
example: on a laboratory report for urinalysis, the red blood cells (RBC) and/or the white blood cells (WBC) in
the urine microscopy can be “TNTC”.
Unable to verify test result: this cancellation is applied to specimens that fail the required confirmatory
analysis following the initial analysis.
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