CTRN0032 Lab+Manual

Central Laboratory Manual
Celltrion, Inc.
CT-P13 3.8
Laboratory Manual
Version 1.0
26JUN2019
Template Version GCL-PM-0059r09, Effective 15JUN2017

Form a, Effective 21Dec2018
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Page Intentionally Left Blank

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Celltrion, Inc. PROTOCOL CT-P13 3.8 VERSION 1.0, 26JUN2019
TABLE OF CONTENTS
1 INTRODUCTION TO OUR SERVICES ......................................................................................... 5
1.1 WELCOME ....................................................................................................................................... 5
1.2 TOLL FREE PHONE ACCESS ................................................................................................................ 6
1.3 GLOSSARY OF LAB MANUAL ABBREVIATIONS AND TERMINOLOGY ......................................................... 7
1.4 HOLIDAY SCHEDULE ......................................................................................................................... 9
1.5 PRECLARUS® INVESTIGATOR SITE PORTAL ........................................................................................10
1.5.1 ONLINE ACCESSIONING: ........................................................................................................11
1.5.2 REPORTS: .............................................................................................................................11
1.5.3 VIEWS ..................................................................................................................................11
1.5.4 QUERIES CENTER: .................................................................................................................11
1.5.5 SUPPLIES: ............................................................................................................................11
1.5.6 DOCUMENTS: ........................................................................................................................11
1.5.7 SHIPMENT: ...........................................................................................................................12
1.5.8 CHANGE USER: ......................................................................................................................12
1.5.9 USER MANAGEMENT:..............................................................................................................12
1.5.10 HELP: ...................................................................................................................................12
1.5.11 ALERT BOX: ..........................................................................................................................12
1.5.12 NEWS TICKER: ......................................................................................................................12
1.5.13 MOBILE APPLICATION: ...........................................................................................................13
2 LABORATORY SUPPLIES....................................................................................................... 14
2.1 VISIT-SPECIFIC COLLECTION KITS ....................................................................................................14
2.2 INITIAL SUPPLIES ...........................................................................................................................15
2.3 RE-ORDERING OF SUPPLIES .............................................................................................................16
2.4 DELIVERY TRANSIT TIMES................................................................................................................16
2.4.1 SUPPLIES ARE SHIPPED FROM: ...............................................................................................16
2.4.2 EXPECTED TRANSIT TIMES *:..................................................................................................16
3 SPECIMEN COLLECTION GUIDE ............................................................................................. 17

3.1 PHLEBOTOMY ..................................................................................................................................17
3.2 SPECIMEN COLLECTION ...................................................................................................................18
3.3 CENTRIFUGATION SPEED .................................................................................................................19
4 SAMPLE LABELING & IDENTIFICATION ................................................................................... 20

4.1 PPD PRE-LABELED TUBES .................................................................................................................20
4.1.1 TUBE LABELING .....................................................................................................................20
4.2 REQUISITION FORMS ......................................................................................................................22
5 SITE STORAGE OF SAMPLES PRIOR TO SHIPMENT ................................................................... 23

5.1 COURIER INFORMATION ..................................................................................................................23
5.1.1 AMBIENT AND/OR REFRIGERATED SAMPLES .............................................................................24
5.1.2 FROZEN SAMPLES ..................................................................................................................24
5.2 ORGANIZING A PICK-UP ..................................................................................................................24
5.2.1 SITE SPECIFIC BOOKING FORMS (DHL) .........................................................................................25
5.3 ORDERING DRY ICE .........................................................................................................................26
5.4 PACKAGING INSTRUCTIONS .............................................................................................................27
5.4.1 AMBIENT SAMPLES.................................................................................................................27
5.4.2 REFRIGERATED SPECIMENS ....................................................................................................29
5.4.3 AMBIENT/REFRIGERATED COMBO BOX .....................................................................................31
5.4.4 FROZEN SPECIMENS (DRY ICE) ...............................................................................................33
5.5 IATA REGULATIONS FOR SHIPPING HUMAN BIOLOGICAL SUBSTANCES .................................................35
5.6 SPECIMEN PRESERVATION (DISASTER CONTINGENCY PLAN) ...............................................................35

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6 SPECIMEN PROCESSING AT THE CENTRAL LABORATORY ........................................................... 36

6.1 SITE INFORMATION .........................................................................................................................36
6.2 SITE QUERIES AND EXCEPTIONS ......................................................................................................36
6.3 LABORATORY REPORTS ....................................................................................................................37
6.3.1 SPECIMEN RECEIVED STATEMENT ............................................................................................37
6.3.2 RESULTS REPORTS (ALSO CALLED DSRS) .................................................................................38
6.3.3 REVISED REPORTS .................................................................................................................38
6.4 CRITICAL VALUES ...........................................................................................................................38
6.5 DEMOGRAPHIC CHANGES REQUEST FORM .........................................................................................39
STUDY SPECIFIC INFORMATION .................................................................................................... 41

APPENDIX I TESTING OVERVIEW .............................................................................................................42
1. LABORATORY OF RECEIPT:......................................................................................................42
2. TURNAROUND TIME AND STABILITY: .......................................................................................42
APPENDIX II REFERENCE RANGES ............................................................................................................44
APPENDIX III SAMPLE COLLECTION AND PROCESSING INSTRUCTIONS ........................................................49
QUANTIFERON TB GOLD PLUS COLLECTION INSTRUCTIONS .............................................................................................49
ERYTHROCYTE SEDIMENTATION RATE TESTING (ESR)....................................................................................................51
STOOL COLLECTION INSTRUCTIONS .......................................................................................................................53
APPENDIX IV LAB MANUAL CHANGE LOG ...................................................................................................56
DOCUMENTATION ....................................................................................................................... 57
CURRICULUM VITAE ..................................................................................................................................58
1. LAB DIRECTOR PPD LABORATORIES-US & PPD LABORATORIES-EU ..............................................58
2. LAB DIRECTOR PPD LABORATORIES SINGAPORE .......................................................................60
CAP AND CLIA CERTIFICATIONS .................................................................................................................61
1. CLIA CERTIFICATION – PPD LABORATORIES US ........................................................................61
2. CAP CERTIFICATION – PPD LABORATORIES US..........................................................................62
3. CAP CERTIFICATION – PPD LABORATORIES EU ..........................................................................63
4. CAP CERTIFICATION – PPD LABORATORIES SINGAPORE .............................................................64

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1 INTRODUCTION TO OUR SERVICES

1.1 WELCOME
PPD®Laboratories maintains state-of-the-art central laboratories that specialize in highly standardized
safety, efficacy and biomarker testing services, as well as biorepository services. We provide flexible
global lab services, including a wide spectrum of routine and sophisticated laboratory analyses. Our
laboratory services are combined with expertise in clinical protocol design, data management and
logistics to consistently deliver the performance needed for successful completion of Phase I-IV clinical
trials.
Our representatives are able to assist with the following routine queries: copies of lab reports, requests
for supplies, questions regarding specimen processing, corrections, and updates. If you should have any
questions, please do not hesitate to contact us.
PPD Laboratories – US (for North, South and Latin America):
2 Tesseneer Drive
Highland Heights, KY 41076, USA
Email: [email protected]
Phone: +1 800 323 2996 or
+1 859 781 8877
Select Option 1 for Help Desk
Select Option 2 for Supplies
Fax: +1 859 781 9310
Hours of Operation: Mon-Fri: 07:30 – 18:00 (EST)
Saturday 08:00-14:00 (EST)
PPD Laboratories – EU (for Europe, Middle East and Africa):
Clusterpark, Kleine Kloosterstraat 19

1932 Zaventem, BELGIUM
Phone: +32 2 725 2127, extension 4300
Fax: +32 2 725 2102
Hours of Operation: Mon-Fri: 08:00 – 18:00 (GMT +1)
Saturday 08:00-16:00 (GMT +1)
PPD Laboratories – SG (for Asia Pacific):

61, Science Park Road
#02-11/15, The Galen, Singapore Science Park II
Singapore 117525
Phone: +65 65946210
Fax: +65 67228394 Hours of Operation: Mon-Fri: 07:00
– 18.00 (UTC/GMT +8)
Saturday site services unavailable

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1.2 TOLL FREE PHONE ACCESS

The toll free numbers listed below can be used to contact our Global Site Services help desk.
A specific code needs to be used when contacting the help desk-
Site Services help desk US (supports North, South and Latin America): 61367
Site Services help desk EU (supports Europe, Middle East and Africa): 61368
Site Services help desk SG (supports Asia Pacific): 87610
If your country is not listed please use the general phone numbers in section 1.1.
*: Wait for second dial tone
COUNTRY WORLDWIDE TOLL-FREE ACCESS #
Austria 0-800-293-631
Belarus 882-000-110-562
Brazil 08000-370-725
Bulgaria 00800-1201178
Canada 1-877-223-3576
Chile 12300201246
Croatia 0800-93-00
Czech Republic 800-222-503
France 0-800-91-7259
Germany 0-800-184-4206
Greece 00-800-1612-2077511
Hungary 06-801-09821
India 000-8000402126
Ireland 1-800-90-4161
Israel 180-945-7253
Italy 800-78-4604
Latvia 800-04855
Mexico 018-002-485-632
Moldova 080061514
Peru 0-800-55650
Peru Lima 51 1 7009338
Poland 00-800-112-46-04
Portugal 800-827-877
Romania 080-040-0086
Russia 88-00-100-6988
Serbia 0800190753
Slovakia 08006-06908
South Africa 0800-99-2256
Spain 900-834-726
Turkey 00-800142077751
Ukraine 0800503184
United States 1-877-223-3576

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1.3 GLOSSARY OF LAB MANUAL ABBREVIATIONS AND TERMINOLOGY

• Accession Number – A unique, non-repeated identifier assigned to a data point or a set of data. There are
accession numbers to define; patient-level data (which are 7 alpha-numeric digits and sample-level data
(which are 11 alpha-numeric digits). Patient-level accession numbers can be found at the top left side of the
laboratory reports. Sample-level accession numbers are reflected as sample barcodes throughout the study.
Note, the barcode found on the top right of the requisition form is not a sample-level or patient-level
accession number, but rather this is an identifier assigned to that particular Laboratory Kit.
• Ambient Temperatures – Typical room temperatures, without refrigeration or freezers involved. Extremely
high temperatures should be avoided.
• APAC – Asia Pacific region
• AWB – Air waybill. A document completed by the site when shipping samples to a defined location via a
shipping courier.
• Bulk Supplies – Any supplies provided in bulk to a site, outside of the laboratory kits.
• CBC – Complete Blood Count. Typically, this is a reference to a Hematology Panel with either an Automated
or Manual Differential cell count.
• CFC – Collection Flow Chart. A document providing the schedule of laboratory events, including expected
samples per visit, processing instructions, kit assignments, estimated blood volumes and other critical
sample information. This document is provided to sites with their initial lab supplies.
• Collection Kit – Also called a Laboratory Kit. A pre-packaged, built-to-order set of laboratory supplies
utilized to collect a specific set of samples for a designated visit. Each kit contains a Requisition Form which
pairs with the specific containers and barcoded items found within that kit. Some visits require more than
one kit and/or bulk supplies additionally to complete all necessary collections for a visit. A packing list of
included supplies can also be found in each kit. Refer to the PPD Collection Flow Chart for details per study.
• CCS – Courier Contact Sheet. A form provided to sites in each region containing courier contact information,
pickup times and transit times for the designated courier. Some couriers will provide a starter packet to sites
directly in lieu of this Courier Contact Sheet which is provided by PPD Laboratories for other couriers.
➢ Most EMEA sites (except few countries, ex. Israel, RU, UA) needed to complete the DIOF
and send it to the designated email/fax number mentioned on the form. Once dry ice is delivered
to the site, site would need to book a collection via local Healthcare phone number
mentioned on the CCS.
➢ Russia, Ukraine, Israel and APAC sites need to call the local Healthcare helpdesk as per
received CCS or Starter Packets and book dry ice/collection.
• Critical Values – Also referred to as Voice Alerts. These are laboratory results which indicate a potential,
serious patient safety concern.
• DCR – Demographic Changes Request Form. A document provided to sites with their initial supply which the
site can fax or email to PPD Site Services in order to correct data points for a patient or lab collection event.
• DSR – Daily Site Report (also known as a Laboratory Report)
• EMEA – Europe, Middle East and Africa
• Exception – Also referred to as a Query. A request for clarification regarding information and/or samples
received from a site due to a potential discrepancy in expected data.
• Flags – Notifications added to specific Laboratory Report results according to protocol requirements,
reference range deviations and/or other important criteria. Flags are meant to draw attention to specifics of
interest or concern, but do not define eligibility for a patient. As such, these are informative but the
Investigator and Sponsor must make actual patient eligibility decisions. PPD Laboratories does not determine
patient eligibility.
• Frozen Temperatures – Typically, a range from -20˚ Celsius or colder
• IATA - International Air Transport Association.
• Preclarus ® Investigator Site Portal– This is an online web-portal provided by PPD Laboratories for sites
to be able to online accession, access their laboratory reports, view their site-specific open queries and to
view supplies on hand and reorder further supplies.
• Laboratory Kit – Also called a Collection Kit. A pre-packaged, built-to-order set of laboratory supplies
utilized to collect a specific set of samples for a designated visit. Each kit contains a Requisition Form which
pairs with the specific containers and barcoded items found within that kit. Some visits require more than
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one kit and/or bulk supplies additionally to complete all necessary collections for a visit. A packing list of
included supplies can also be found in each kit. Refer to the PPD Collection Flow Chart for details p er study.
• Packing List – An informative document provided within each Laboratory Kit noting all supplies found within
that kit, including any specific barcodes applied to containers in that kit.
• PPD help desk – Also referred to as PPD Global Site Services. A dedicated team supporting sites globally
for general questions, supply orders, query resolution and data updates for each study. There are regional
team locations supporting defined regions as described in this Laboratory Manual. Contact information for
each regional team can also be found at the bottom of the Collection Flow Chart for the study.
• PPD EU – PPD’s Laboratory facility in Europe, located in Zaventem, Belgium
• PPD SG – PPD’s Laboratory facility in Singapore
• PPD Global Site Services – Also referred to as the PPD help desk. A dedicated team supporting sites
globally for general questions, supply orders, query resolution and data updates for each study. There are
regional team locations supporting defined regions as described in this Laboratory Manual. Contact
information for each regional team can also be found at the bottom of the Collection Flow Chart for the
study.
• PPD US – PPD’s Laboratory facility in the United States of America, located in Highland Heights, Kentucky
• Query – Also referred to as an Exception. A request for clarification regarding information and/or samples
received from a site due to a potential discrepancy in expected data.
• Reference Range – The normal range of laboratory results according to PPD Laboratories for a specific
assay and population.
• Refrigerated Temperatures – 2˚ to 8˚ Celsius
• Requisition Form – A two-part (white top page, yellow second page) document provided within Laboratory
Kits which sites complete and submit with samples found within that kit to PPD Laboratories. The information
received from this document is loaded into the PPD Laboratory database for that patient and lab event. The
white, top copy should be submitted to PPD Laboratories with the first shipment of samples per visit. The
yellow copy should be retained at the site. When submitting frozen samples on a subsequent basis for a visit
with samples already submitted previously, a second copy of the same form should not be re-submitted
again to PPD Laboratories.
• RPM – Revolutions per Minute.
• Specimen Received Statement – A report provided to sites after submission of samples to PPD
Laboratories. Upon receipt of the requisition form for a visit, this report will be sent to sites to note all
samples which have been received as well as any expected samples for that visit which have not yet been
received. Sites should retain these reports for their records and follow up with PPD Laboratories for any
samples expected but not yet received.
• Supply Reorder Form – A document provided to sites with their initial supply which the site can fax or
email to PPD Site Services to re-order supplies.
• Voice Alerts – Also referred to as Critical Values. These are laboratory results which indicate a potent ial,
serious patient safety concern.

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1.4 HOLIDAY SCHEDULE

PPD Laboratories will be closed and unable to receive shipments on the holidays listed below. Please
consider these holidays, as well as transit times from your site, when scheduling subject visits around
these days.
Please check with your courier regarding local holidays, as these vary between regions and may affect
shipments from your site, even if PPD Laboratories is open and able to receive samples.
PPD Laboratories US
New Year’s Day 01 Jan 2019 01 Jan 2020 01 Jan 2021
Memorial Day 27 May 2019 25 May 2020 31 May 2021
Independence Day 04 Jul 2019 04 Jul 2020 04 Jul 2021
Labor Day 02 Sep 2019 07 Sep 2020 06 Sep 2021
Thanksgiving Day 28 Nov 2019 26 Nov 2020 25 Nov 2021
Christmas Day 25 Dec 2019 25 Dec 2020 25 Dec 2021
PPD Laboratories Europe
Easter Monday 22 Apr 2019 13 Apr 2020 05 April 2021
Pentecost Monday 10 Jun 2019 01 Jun 2020 24 May 2021
PPD Laboratories Singapore
Chinese New Year 05 Feb 2019 25 Jan 2020 12 Feb 2021

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1.5 Preclarus® Investigator Site Portal

Preclarus® Investigator Site Portal is a secure web portal for:
• Online accessioning of samples (at the collection site) to strengthen chain of custody and make
samples available for testing sooner.
• On-site biorepository tools to help manage samples and track them to their final destinations.
• Simplified subject registration with real-time error checking and resolution to ensure data
integrity.
• Automatic alerts for critical values to facilitate patient management.
• Online collection kit ordering and inventory management.
• Built-in reports to help trend lab results and manage patients.
The portal can be accessed at: http://preclaruslabdata.ppdi.com

User Account Activation
Upon initial site address entry performed by PPD® Laboratories Database, an activation email is
sent to the Principal Investigator’s and/or Study Coordinator’s email address.
The Principal Investigator or Study Coordinator is required to complete the following steps to activate
the account:
· Click on the link within the email to activate site
· USER ID = email address
· Create password and enter your name at prompt
· Email account activation link will expire after seven calendar days after receipt.
· Contact the local Investigator Services help desk if activation has expired in order to have
another activation email sent.
· Log into account using the newly created password and the user id (email address)
The complete User Guide and videos are available online and can be accessed by selecting the Help tab
within the portal.

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1.5.1 Online Accessioning:

Register a new subject for clinical study
Enter the details in the online requisition and sample accessioning form
View the existing requisition form for a clinical study
PART 1 Logging In, Registering New Subjects, Accessioning Samples, and Creating Sample
Shipments
www.youtube.com/watch?v=omyL__7oFpU
PART 2 Viewing Reports, Supplies, Query Center, and Viewing Documents

www.youtube.com/watch?v=34g-GmczCz4
1.5.2 Reports:
View Lab reports
1.5.3 Views
Patient level results trending
Result fliltering
Graphs and Charts
Subject Demographics
1.5.4 Queries Center:

View, print and respond to queries raised by PPD® Laboratories Central Labs pertaining to
any discrepancies in a particular study
1.5.5 Supplies:
Request re-supply order
Inventory management tools
Order Tracking
Alerts and Reminders
1.5.6 Documents:
View and print investigator manuals and other site documents available

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1.5.7 Shipment:
Create Shipments and assign air waybills
Shipment History
1.5.8 Change User:

The Change User tab is available for all users with administrator access, the Study Coordinator
does not have access to the User Management ‘Investigator Role’ unless the PI grants access.
1.5.9 User Management:

The administrator account access will allow the user to Add/Remove account access for site
personnel.
1.5.10 Help:
Display contact information for PPD® Laboratories Central Labs across the globe.
1.5.11 Alert Box:

Critical Alerts - section shows the number of critical reports with an out of reference range
value that requires attention. Click the link to view the critical reports
Open queries - section shows the number of queries that require a response. Click the link to
view the Query Center page
Unshipped Samples - section shows the number of samples not shipped to PPD® Laboratories
Central Labs. Click link to view the unshipped samples report.
View Missing Samples - link allows you to view a list of samples not recorded in the subject’s
visit. Click the link to view the missing samples report. In addition, you can update the status for
the missing samples and generate a printed report
New subject - results section shows the number of subject reports not viewed across all
authorized, protocols and site during the last 5 days
1.5.12 News Ticker:

This section displays latest news related to PPD® Laboratories Central Labs, highlighting all the
latest and current happenings.

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1.5.13 Mobile Application:
• For Site Members Only.

• Downloadable Mobile application available:
- Google Play store (Android or Android Tablet 5+)
- Apple iTunes application store (iOS for phone or tablet 10+)
Accounts are created just the same as Preclarus Lab Data for SITE USERS.

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2 LABORATORY SUPPLIES
KEY POINTS FOR THIS SECTION:
• Initial Supplies are triggered by the clinical team. Kits required later in the study are
not included in the initial supply and need to be ordered by the site closer to date of
actual need.
• Resupply Orders are triggered by the site. These can be made using the supply reorder
forms or through the Preclarus® Investigator Site Portal.
• PPD Laboratories requires a minimum of 5 business days to process an order
with an additional 3-5 business days for transit time based on courier
requirements and location of site (see section 2.4.2).
• Please note it is the site’s responsibility to monitor supplies for quantity and expiration
dates. PPD Laboratories does not automatically send resupplies to sites.
• Do Not Use Expired Kits. If samples are collected in an expired kit results may not
be reported.
2.1 VISIT-SPECIFIC COLLECTION KITS

At study start you will be provided with visit-specific PPD Laboratories collection kits. It is possible that
multiple visits will use the same kit type or that a single visit will use multiple kit types.
Each kit type (A, B, C, …), or a combination of kits will contain all tubes and requisition forms needed
for the collection of all samples for a certain visit. The kit box, which contains the collection supplies,
doubles as the ambient mailer for the return shipment of samples to the central lab. Instructions
pertaining to sample packaging are found in Section 5.
On the Collection Flow Chart provided to you separately, you can find information on which kit(s) to use
for which visit.
Expiry dates will be clearly marked on the label that is placed on the outside of the collection
kit box. The expiry date is always reflective of the tube that expires the earliest. The expiry
date displayed on the label is good to the last day of the month displayed unless otherwise
noted
Each kit is labeled with the following information but not limited to:
- Protocol reference
- Visit(s)
- Kit lot number
- Expiration date
A packing list will be included within each kit detailing the kit contents. When the kit is selected for use,
enter the patient identifier and retain the list in the investigator site file.

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2.2 INITIAL SUPPLIES

PPD Laboratories will provide you with the supplies required to collect, prepare and ship samples for this
study. Initial Supply orders are ordered/requested by the Clinical Team.
Initial supplies may include the following:
• PPD Laboratories Collection Kits – enough for a pre-determined amount of subjects and visits
• Courier Information and pre-printed air waybills
• Laboratory Manual
• Collection Flow Chart
• Shipping boxes and material (if applicable)
• General bulk ancillary supplies (if applicable)
• Re-Supply Order Form
• Demographics Change Form

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Please note that kits required later in the study may not be included in the initial supply and
will need to be ordered by the site closer to the date for which they will be required.
2.3 RE-ORDERING OF SUPPLIES

You will be alerted by email and fax if your inventory drops below a pre-defined threshold so that you
can determine if you need to order additional supplies.
Supplies can be reordered in three ways:

1. Through the Preclarus® Investigator Site Portal (recommended)
2. Using the Supply Reorder Form and faxing the request
3. Investigator Services or site services for each region will accept phone orders as well as email
orders
When ordering supplies through the Preclarus® Investigator Site Portal (see Section 1.5 Preclarus®
Investigator Site Portal), a confirmation email will be sent automatically to your site’s email address.
The study-specific Supply Reorder Form is provided with your initial supplies. Once the form is
complete, you can fax or email the re-order form to the contact information displayed on the form for
processing. You will not receive confirmation of receipt for the re-order.
Re-orders should be placed enough in advance of need to allow for processing and shipment
of the order. PPD requires 5 business days to process orders (see section 2.4.2 for transit
times)
2.4 DELIVERY TRANSIT TIMES

2.4.1 Supplies are shipped from:
PPD EU: Europe, Africa, Middle Eastern and Asia Pacific countries
PPD US: North, South and Latin America
2.4.2 Expected transit times *:

South and Latin America 3-10 business days based on country
Asia Pacific 5-10 business days
North America 3-5 business days
Western Europe 1-2 business days
Eastern Europe 3-4 business days
South Africa 3-5 business days
*Actual delivery times may vary due to custom constraints, special documentation requirements
or weather related issues beyond our control. Countries in need of importation approvals will be
processed 5 business days after importation approval is received from the clinical team.

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3 SPECIMEN COLLECTION GUIDE

• Respect good phlebotomy practices to obtain good quality specimens.

• The subject is to be seated at least five minutes prior to blood collection.
• Refer to the Collection Flow Chart for the order of draw, specimen processing and
shipping instructions.
3.1 PHLEBOTOMY
It is the responsibility of the principal investigator and/or site coordinator to assure that the person(s)
performing phlebotomy are appropriately trained per local regulations, and are using good phlebotomy
technique.
Tips for Good Phlebotomy:

• Place Tourniquet 7 to 10 cm above the venipuncture site. If using a blood pressure cuff as a
tourniquet, inflate to 40 mm Hg.
• Tourniquet application for preliminary vein selection should not exceed one minute as localized
stasis with hemoconcentration and blood infiltration into tissue may occur. This may result in
erroneously elevated protein based analytes.
• The subject may close their fist, but should NOT pump their fist. This may cause changes in
certain analytes such as potassium.
• Clean the area with a 70% isopropyl alcohol pad using a circular motion from the center to the
periphery. Allow the area to air dry to prevent hemolysis and to prevent the subject from
experiencing a burning sensation.
• Needle selection:
o Use the needle provided in the kit.
o In the case of using a butterfly needle make sure to fill first a discard tube to allow the
dead volume of 0.5ml to be eliminated before collecting the tubes for this study
• Release the tourniquet as soon as possible after the blood begins to flow
• Allow the tube to fill completely. Under filling may cause erroneous results, especially for
coagulation studies.
• Immediately mix each tube as defined on the Collection Flow Chart.

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3.2 SPECIMEN COLLECTION

You have been provided a Collection Flow Chart with your initial supplies. This flow chart is a separate
document from the PPD Laboratories Manual. The flow chart will provide you an overview of the
collections needed for this study at designated visits.
Blood collection tubes must be drawn in the order displayed on your Collection Flow Chart to avoid
cross contamination between different types of tubes (with or without additives).
The following is only an example.

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3.3 CENTRIFUGATION SPEED

For best results, please centrifuge your samples as per the instructions on the Collection Flow Chart
provided for this study.
As the relative centrifugal force varies with the radius of the centrifuge, the table below will assist with
determining the right speed setting of the centrifuge. Measure the distance from the center of the
centrifuge (rotating axis) to the end of the tube (radius).
Determine the right speed (rpm) using the table below:
RCF = 1.12 x 10-5 x r x (RPM)2
RCF
RPM =
1.12  105  r
- RPM: revolutions per minute (speed of the centrifuge)

- RCF: relative centrifugal force (the centrifugal force generated = g)
- r (radius, in cm): the distance from the center of the centrifuge head to the bottom of the tube
holder in the centrifuge bucket

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4 SAMPLE LABELING & IDENTIFICATION

• Draw tubes and transfer vials will be provided pre-labeled.
• Write clearly on each label in English.
• Complete the secondary ID on every tube (typically this is the full patient Subject ID).
Incomplete or missing information could delay reporting.
• Prepare a Requisition form for every kit used. Note, a paper requisition form is not
required when using the Preclarus® Investigator Site Portal to accession samples on-
line.
• Once a kit has been used, the remaining tubes in the kit must be discarded.
• The first shipment of every kit should include the white portion of the requisition form.
• Keep the yellow portion of the Requisition form at the site.
• The visit and patient information on the requisition form is critical to accession samples.
• Incomplete or missing requisition forms will delay testing and put your lab report on
hold.
• Retain the PPD Laboratories Packing List (inside each kit box) at the site for your record.
Please do not ship to back to PPD Laboratories.
• Additional tubes may be used from another kit provided the sample name is EXACTLY
the same. The entire kit must be discarded after removal of any pre-labeled items. Send
the requisition form from each kit and discard unused tubes from the additional kit.
4.1 PPD PRE-LABELED TUBES

Please use requisition form(s) provided per kit. The kit contains all pre labeled tubes required for a
particular visit. All specimens shipped to PPD Laboratories need to be identified with a secondary ID.
Each label has a unique 11-digit identifier (barcode): e.g. A1234567890.
4.1.1 Tube labeling
Both the collection tubes and/or transfer vials are provided pre-labeled. Write the secondary
identifier clearly using a blue or black pen only (no markers) on both the draw tube and
transfer vial to prevent mix up. The word draw tube will be specified on the draw tube label.
For some samples where the draw tube is required to be processed at the site, this should be
discarded after the processed sample has been aliquoted into the appropriate transfer vials.
For others samples, the draw tube will not be processed at site and will need to be sent to
PPD Laboratories. Instructions for this will be located on the collection flowchart to advise
which tubes should be sent to PPD Laboratories.

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a) Example of a specimen with a transfer vial b) Example of a specimen without a transfer vial
Select collection kit Select collection kit
Drawtube Write the Subject

Drawtube Write the Subject
ID
ID
Write the Subject

ID
Specimen Transfer Vial

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4.2 REQUISITION FORMS

A requisition form must be provided with every kit. Note, a paper requisition form is not
required when using the Preclarus® Investigator Site Portal to accession samples on-line.
Online accessioning is recommended.
o Complete all information required for the visit you are collecting.
o Use a blue or black pen only (no markers), press firmly and write clearly.
• The requisition labels will be pre-applied to the white and yellow copies of the requisition form.
• Return the white copy to PPD when you ship the visit samples. (Only with first
shipment for that visit).
o Fold the requisition form in half and place between the secondary (sample bag) and
outer packaging (shipping box).
• Retain the yellow copy of the requisition form for your records.
Requisition form (and copy) will be pre-labeled with the requisition label.

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5 SITE STORAGE OF SAMPLES PRIOR TO SHIPMENT

Follow the PPD Laboratories Collection Flow Chart for each study regarding appropriate storage
temperatures and length of storage prior to shipping for each sample type.
PPD Laboratories is not involved in monitoring of site storage unit temperature logs and/or notifications
of excursions from expected temperatures for samples stored on-site.
Sites should maintain appropriate temperature records for their refrigeration and freezer units on-site,
including any necessary documentation for temperature excursions that occur.
The study sponsor and clinical monitoring team should be notified accordingly by the site if
the refrigeration or freezer units utilized on site have temperature excursions outside of
sponsor-defined ranges acceptable for those units while containing laboratory samples for
each study.
• Refer to your courier contact sheet for all information on how to organize a shipment.
• Respect last call times to ensure that your pick-up still occurs on the same day.
• Your kit box can be used as an ambient shipping box [apply air waybill (AWB) on the bottom].
• Ship ambient samples according to the Collection Flow Chart instructions, typically on the day
of collection.
• Avoid shipping frozen samples over the weekend.
• Dry ice delivery on Monday is not possible for all sites in EU and US.
o Dry ice can be ordered for delivery on Friday and kept in the freezer until Monday
shipment but should be avoided when possible.
• PPD is able to receive samples from Monday through Saturday.
DO NOT forget to apply a Saturday Delivery sticker on your shipping box (ambient or frozen) when
shipped on a Thursday (sites in 48hr zone) or Friday (sites in 24hr zone).
5.1 COURIER INFORMATION

Depending on your courier you will receive a Courier Contact Sheet separately or within your initial lab
supply shipment that will contain the following site specific courier information:
Courier booking center telephone number
• Courier account number
• Last call time for booking to ensure same day pick-up
• Who to contact to obtain shipping materials
• How to order dry ice. Sites located in the USA will obtain dry ice locally.
Note: Sites located in the USA will receive packaging supplies from PPD and must contact their local
FedEx for information on last call in times.

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5.1.1 Ambient and/or Refrigerated samples

Ship all ambient and/or refrigerated samples as directed on the CFC (Collection Flow Chart). Please keep
in mind that standard couriers only perform pick-ups on business days. Prior to packing, specimens
should be stored at ambient temperature.
If you have refrigerated shipments, ensure that the appropriate number of Gel Wraps or Gel Packs are
frozen for the required amount of time before use, as per the instructions in section 5.4.2 and 5.4.3. The
combination shipper will display this notice on the top of the box for your convenience.
5.1.2 Frozen samples

We recommend sending dry ice shipments Monday through Wednesday to ensure arrival before the
weekend. Remember to include the amount of dry ice in kgs on your frozen shipper and use a dry ice
waybill (UN1845 preprinted on waybill).
5.2 ORGANIZING A PICK-UP

1) Call the courier at the number specified on your courier contact sheet before the last calling time.
• Last call time for booking to ensure same day pick-up
2) Provide the account number.
3) Pack your samples as detailed in the “Packaging instructions”.
4) Provide shipping box to courier at pick-up. Retain a copy of the air waybill (AWB) and/or AWB
number on site.
5) If applicable for your site, please provide a Commercial Invoice (not applicable for US sites and
sites within the European Union) and a Custom Declaration Form (only applicable for sites in
Latin America) at pick-up.

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5.2.1 Site Specific Booking Forms (DHL)

Only for sites located in EMEA, Africa, Asia Pacific and who are using DHL as shipping
courier.
DHL will create Site Specific booking forms and instructions and will sent these directly to the site.
Booking Form Instructions
• EMEA sites* have to complete the booking form and email it to the dedicated DHL Healthcare
team who will take care of both dry ice request and sample collection booking
• Russia, Ukraine and APAC sites* will also be receiving site specific DHL starter packs,
however, they will continue to call in local Healthcare phone lines to order dry ice/ book a
collection
*Except Israel, they continue to have samples collection based on the courier contact sheet

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5.3 ORDERING DRY ICE

1) North, South and Latin America
• Dry ice is to be obtained locally unless otherwise specified by PPD Laboratories per study.
• When dry ice is NOT available in your location, additional arrangements are available. Please
contact your local Site Services help desk for assistance.
• Shipping boxes will be provided to you by PPD.
• Air waybills (AWB) will be provided to you by PPD. Note that when supply orders indicate
“DIRECT–SHIP”, PPD will order the waybills for your site which will be shipped directly to you
via the courier instead of PPD.
2) Europe, Middle East, Africa, Asia Pacific and the Rest of the World – TNT only
Depending on your site’s location, there are two methods to obtain dry ice:
• If dry ice is to be ordered with the local courier office, use the phone number listed on the Courier
Contact Sheet to get in contact with the courier.
• If dry ice is to be ordered using a Dry Ice Order form, fax the completed form (provided to you
with your initial supplies) to the number on the form at least 1 or 2 days (depending on your
transit time) prior to shipment. Please note that dry ice delivery on Monday is not possible.
Consult the courier listed on the Dry Ice Order Form for your site's transit time.
Europe
3) Europe Middle East, Africa, Asia Pacific and the Rest of the World – DHL ONLY
Dry Ice, Shipping Box and AWB is provided by the courier
Follow the instruction on your site specific Booking form:
1) Complete the booking form
2) Email the the booking form to the dedicated DHL healthcare team
3) The DHL healthcare team will take care of both Dry ice request and sample collection booking.

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5.4 PACKAGING INSTRUCTIONS
5.4.1 Ambient samples

The PPD kit box is to be used for shipment of ambient specimens. If the kit box is damaged or unusable,
please utilize an alternate kit box for shipment of samples, or notify PPD Central Labs that a replacement
ambient shipper will be required accordingly.
• One kit box can be used to send specimens for different subjects (make sure to include a
requisition form per subject/visit). Note,a paper requisition form is not required when using the
Preclarus® Investigator Site Portal to accession samples on-line.

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1) Insert the ambient vials into the sample bag with absorbent pad. Seal tightly.
a. Note that you may place up to 24 tubes in the sample bag and that tubes do not require
separation.
2) Place the sealed specimen bag(s) between the unconditioned double gel wrap. Note that the
gel wrap should not be refrigerated or frozen as it is intended only to protect the sample.
3) Place the gel wrapped specimen in the ambient box.
4) Fold the requisition form in half and place on top of the sealed sample bag inside the box. If
performing online accessioning (recommended), the paper requisition form does NOT need to be
include within the shipment.
5) Apply the security seal connecting the outer flap and the bottom of the box, note that it is also
acceptable to ship the ambient shipper without using the security seal if needed.
6) Apply the return air waybill to the bottom of the box when not using a lab pack envelope.
7) When using a lab pack envelope, insert the ambient shipper into the lab pack envelope and apply
the return air waybill to the envelope.
a. Note that when using a lab pack envelope multiple ambient boxes may be combined
together in the same package.
PLEASE DO NOT TAPE THE OUTER BOX – THE SHIPPING BOX DOES NOT REQUIRE TAPING

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5.4.2 Refrigerated specimens

The list of contents may have been printed on your shipping box for your convenience. Please complete
the applicable fields where indicated.
Attention for refrigerated shipments: 3 PPD Gel Wraps need to be frozen for at least 24 hrs
at -18C or -4F or below before use. (Summer)

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Attention for refrigerated shipments: 2 PPD Gel Wraps need to be frozen for at least 24 hrs
at -18C or -4F or below before use. (Winter)

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5.4.3 Ambient/Refrigerated Combo Box

3 PPD Gel Wraps need to be frozen for at least 24 hrs at -18C or -4F or below before use.
(Summer)

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2 PPD Gel Wraps need to be frozen for at least 24 hrs at -18C or -4F or below before use.
(Winter)

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5.4.4 Frozen Specimens (Dry Ice)

When using PPD box:
1 2
3
5
4
1. Directly prior to packing, insert the frozen vials into the specimen bag(s) and seal tightly.
2. Place the sealed specimen bag(s) into the inner box.
3. Layer the bottom of the inner box with dry ice and place the sealed specimen bag(s) into the inner box.
Note that each dry ice shipper comes with the appropriate, maximum number of sample bags that
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should be utilized for that shipper. Each sample bag holds up to a maximum of 25 samples per bag. Do
not exceed the number of samples per bag or the number of specimen bags per shipper beyond what
is provided with each shipper. If this guidance is not followed, there may be insufficient dry ice for the
transport and the samples may be thawed during transit.
IMPORTANT NOTE: If samples are received at the incorrect condition at PPD Labs from the site, the
site will be notified via query of the issue. The site should work with the sponsor and CRO team to
determine if the sample must be replaced or re-drawn due to the error.
4. Add additional dry ice until the box is completely filled. Ensure that an appropriate amount of dry ice,
including at least the minimum amount described below per dry ice shipper type, is included in the box.
5. Place the Styrofoam lid on top of the inner box and place the list of contents on top of the lid along with
a copy of the requisition form. Ensure that the requisition form is NOT placed inside the container with
the dry ice itself or it may be damaged during transit, resulting in potential issues on receipt.
6. Note that if your frozen shipper has the list of contents printed on the inner flap of the box it will not be
necessary to complete the list of contents form, simply fill in the information on where applicable.
7. Close the outer cardboard box.
8. Apply the AWB to the top of the box. When dry ice weight is not already pre-filled, entry of the weight
is required to be hand entered prior to the courier accepting the package.
North, South and Latin America: Dry Ice Shipper Capacities (typically provided by PPD Labs)
Description of Shipping Box

Number of Transit Hrs Sample
(Refer to PPD Site Portal Min Amount Max Wt of Maximum #
Remains Frozen Assuming Filled
description per box if ordered of Dry Ice Shipper of Samples
with Dry Ice Weight Required
via PPD)
Box-Frozen Shipper-5lb. W/(1) 5 lbs 6 lbs 25 36 Hours

Sample Bag Max/25 Samples
Sample Bags Max/50 Samples
Europe, Middle East and Africa: Dry Ice Shipper Capacities (Note: couriers typically provide dry ice
shippers in EMEA regions)
Max
Max Wt Total #
Amount Number of Transit Hrs
Shipping from Site to Lab Description of of
of Dry Sample Remains Frozen
Shipper Samples
Ice
Box-PHT14 Frozen Shipper 8 kg 10 kg 25 72 Hours
Asia Pacific: Dry Ice Shipper Capacities (typically provided by PPD Labs)
Max
Max Wt Total #
Amount Number of Transit Hrs
Shipping from Site to Lab Description of of
of Dry Sample Remains Frozen
Shipper Samples
Ice
Box-Frozen Shipper-20lb. W/(3) Sample Bags Max/75

12 kg 13 kg 75 96 Hours
Samples
Box-Frozen Shipper 10lb. W/(2) Sample Bags Max/50 Samples 5 kg 6 kg 50 72 Hours

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5.5 IATA REGULATIONS FOR SHIPPING HUMAN BIOLOGICAL SUBSTANCES

IATA rules list the training requirements for persons involved with hazardous materials, including the
packaging of human biological specimens for shipment to a clinical laboratory. PPD Laboratories does
not provide IATA training; however, we will provide all materials for compliance with IATA regulations
packing instructions 650. It is the shippers (site’s) responsibility to have all employees responsible for
packaging and shipping biological specimens IATA trained. For information regarding IATA requirements
please refer to the official resources to obtain additional information/training: www.icao.int
http://www.saftpak.com http://www.highqllc.com www.ercweb.com www.dgitraining.com.
5.6 SPECIMEN PRESERVATION (DISASTER CONTINGENCY PLAN)

This PPD Laboratories contingency plan has been established to give your site instructions on how to
proceed should air travel be disrupted for a period of time.
Please note that this is the general PPD disaster contingency plan and should unforeseen events prevent
shipment of samples long term, you will be informed at that time for study specific actions to take for
your samples. The below details are informative.
1) Frozen samples
Specimens that are required to be frozen and shipped with dry ice should remain at the site in a non-
frost free freezer at -20°C or below until notification is received from the sponsor or PPD Laboratories
that safe transport of specimens is certain.
2) Non-frozen samples
Specimens already drawn should be kept at site unless the sponsor has directed your site to have these
tests performed locally. If you are required to perform a test locally, the sponsor will notify you in writing.
For short term storage:
- Hematology (CBC): the specimens are stable for a maximum of 3 days at ambient temperature.
Shipment of samples on a Friday in regions where transit may result in delivery on a Monday can
lead to sample loss due to lack of stability.
- Specimens for safety chemistry, lipid profile (if applicable for the study) and other specimens
that are ordinarily shipped at ambient temperature or with ice refrigerant packs should be
refrigerated at 2-8°C. These specimens are stable for at least one week.
If safe transport of specimen cannot be assured within 5 calendar days of collection, the sponsor may
notify you to do one or more of the following:
• Perform Hematology / urinalysis / hemoglobin A1c in your local laboratory (if applicable for the
study)
• Perform safety chemistry in your local laboratory if indicated by the subject’s condition (if
applicable for the study)
• Freeze lipid profile plasma and reserve sample vials in a non frost free freezer at –15˚ to –20˚C
or below (if applicable for the study).
• Freeze serum vials in a non frost free freezer at –15˚ to –20˚C or below (if applicable for the
study).
Contact PPD Laboratories or the sponsor regarding the handling of any other specimens.

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6 SPECIMEN PROCESSING AT THE CENTRAL LABORATORY

• Inform PPD immediately if your site details change.

• Queries are faxed on the day of receipt of your samples and are visible on the Preclarus®
Investigator Site Portal.
• Laboratory Reports will not be sent nor available on the Preclarus® Investigator Site
Portal if you have pending queries.
• Data for safety samples are faxed and visible on the site portal on the day of receipt of the
samples (unless there are pending queries).
• All protocol defined exclusion/inclusion/discontinuation criteria are flagged on the laboratory
report. For appropriate actions always refer to the protocol.
• Critical Values are sent to the sites separately by fax and are not delayed by pending queries.
They require acknowledgement of receipt by site either by phone, email, fax, or via the
Preclarus® Investigator Site Portal within 1 business day.
6.1 SITE INFORMATION

For each site, the following information is set up in our database:
• Site number
• Supply delivery address
• Sample pick up address
• Site contact name (other than PI)
• Phone number
• Fax number
• PI Email Address-Must have PI email address in order to activate the Preclarus® Investigator
Site Portal
In order to maintain effective communication, please proactively inform our Global Site Services
help desk (see section 1.1) should any of the details related to the above information change during
study conduct.
6.2 SITE QUERIES AND EXCEPTIONS

When samples are received in the laboratory an evaluation is performed on the requisition and the
samples to ensure completeness and accuracy of information. When demographic information is missing,
unreadable, or discrepant on the tube label or the requisition form, queries are generated, and the
following process occurs:
1) An exception is created by our database which blocks the laboratory report and the results cannot
be provided to the site.
2) PPD Global Site Services help desk will query the site by fax, requesting the missing information.
After the initial quesry is sent, new queries are faxed after 2 business days to allow the site time
to respond. Sites will then be queried every 1 business day until a confirmation of the missing
information is received.
3) Sites are also able to view their queries online through the Preclarus® Investigator Site Portal
(see section 1.4).
4) The site must complete the query form with the missing information and fax back to the PPD
Global Site Services Help Desk. Note, that when using the Preclarus® Investigator Site Portal,
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sites may respond to the query on-line and the Global Site Services Help Desk will process your
comments.
5) Upon receipt of the fax and/or on-line comments, the exception is resolved and the Laboratory
Report is released.
6) The site will receive the laboratory report via automated fax overnight at the same time the
report is viewable on the Preclarus® Investigator Site Portal.
It is imperative that all queries be resolved quickly to assure results are received in a timely
manner. Otherwise open queries will keep the reports/results from being available.
6.3 LABORATORY REPORTS

The laboratory reports will be provided to the sites on the Preclarus® Investigator Site Portal
or via overnight fax.
6.3.1 Specimen Received Statement

• This statement will list the subject information in the header and all of the samples expected
for the visit in the body of the statement.
• The statement lists specimen status as either Received or Not Received. If the site did not
collect the sample, you can request the Global Site Services help desk to change
the status to Not Collected. Otherwise, the sample will appear as Missing and will
be listed for follow up with the Study Management team.
• When utilizing the Preclarus® Investigator Site Portal you can update the status on-line
for the missing samples to Not Collected, additionally you can print the list of missing samples
for your convenience.
Demographic information
Sample information:
- Received
- Not Received
- Collection Date
- Received Date
- Sample Accession Number

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6.3.2 Results Reports (also called DSRs)

• List of all test results, reference ranges, units and flags.
Demographic information
Clinical Data
Test Results
Reference Ranges
Comment Legend (only on last page
of results)
Note: Columns for Clinical

Significance (CS) and PI initials only
appear if a test result is outside of
the laboratory reference range.
Investigator’s signature line: only on

last page
Footer with Clinical Significance Legend
6.3.3 Revised Reports

• Revised Results: show the revised current result, the previous test results, reference ranges,
units and flags.
• Revised Demographic/Clinical Data: show revised data specific to a visit with current and
previous values (e.g. weight or fasting status).
• Revised subject data: shows revised data for the subject with current and previous values
(e.g. Subject ID or gender) and all visits affected by this revision.
• Shows all visits affected by the revision.
6.4 Critical Values

There are 4 types of results:
1) Normal result within reference range.
2) Result outside of laboratory reference ranges: L (Low) or H (High) reported next to test result
(value) on the laboratory report.
3) Protocol-specific result annotation: symbol (e.g. S01) reported next to test result (value)
additional comment on cover page indicating the protocol-specific rules/flagging.
4) Critical value: LC (Low Critical) or HC (High Critical) reported next to test result (value) on
Laboratory report without additional comment on cover page.

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Critical Value: an extremely high or low value which is considered to be life threatening. These cut-off
values are defined by the PPD medical / laboratory directors and are independent of protocol. They can
be found on the reference ranges table in appendix 1. In the event a Critical Value is reported, PPD will
contact the site to inform them of the critical value for that subject:
1) A notification is faxed automatically to the site to inform them of the critical value for a certain
subject/visit/test.
2) The site will be contacted via phone or email to obtain accurate contact information (if the fax
transition failed) and confirm the value has been received.
3) Confirmation of receipt by site or sponsor is required by email, phone or fax and/or on-
line using the Preclarus® Investigator Site Portal. This should be provided within 24
hours.
4) Critical values are not put on hold due to pending queries.
5) Investigator sites will be notified of critical values regardless of blinding.
6.5 Demographic Changes Request Form

Upon receipt of the laboratory report, the investigator and/or study coordinator is requested to
thoroughly check the information on the report.
In case a discrepancy is noted:
1) Complete the Demographic Changes Request form (provided in initial supplies shipment).
Complete the site information
PPD Global Site Services help desk:

contact information, this information can also be found in
the help section of the Preclarus® Investigator Site
Portal
Subject demographic information:
Current information: Incorrect data on LAB

REPORT
New information: Correct information that

should be incorporated
2) Fax or email the completed demographic changes request form to PPD Laboratories.
3) PPD Laboratories will update the database accordingly.

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4) A revised laboratory report will be available in the Preclarus® Investigator Site Portal or
faxed to the site overnight.

Page 40 of 64
Study Specific Information

Page 41 of 64
APPENDIX I TESTING OVERVIEW
1. Laboratory of receipt:
Samples will need to be sent to the following PPD location(s) depending on your location:
PPD US: North, South and Latin America
PPD EU: Europe, Middle East and African countries
PPD SG: Asia Pacific countries
2. Turnaround time and stability:
Testing
Test Temperature Stability TAT
location
CHEMISTRY PANEL US, EU, SG Ambient 5 days 1 day
CREATININE CLEARANCE
N/A N/A
(Cockcroft Gault formula) US, EU, SG 1 day
(Calculation) (Calculation)
(Estimated by Weight)
C REACTIVE PROTEIN US, EU, SG Ambient 11 days 1 day
HEP B sAG PANEL US, EU Ambient 5 days 1 day
HEP B sAB TOTAL US, EU Ambient 5 days 2 days
HEP B cAB TOTAL US, EU Ambient 1 week 2 days
HEP C ANTIBODY, IgG US, EU Ambient 5 days 1 day
Hepatitis C, Viral Load RNA

US, EU Frozen 2 months 7 days
(Qualitative)
HIV 1 & 2 SCREEN US, EU Ambient 5 days 1 day
Ambient
HIV CONFIRMATION BY INNO-
EU (intra-GCL shipment to EU 5 days 7 days
LIA SCORE
should be frozen)
HEPATITIS B VIRAL LOAD DNA

EU Frozen 6 weeks 7 days
(Qualitative)
SERUM βHCG (Qualitative) US, EU, SG Ambient 5 days 1 day
SERUM βHCG (Quantitative) US, EU, SG Ambient 5 days 1 day
CHOLESTEROL, HDL US, EU, SG Ambient 5 days 1 day
CREATININE KINASE - MB US, EU, SG Frozen 3 months 1 day
TROPONIN I US, EU, SG Frozen 1 year 1 day
COMPLEMENT COMPONENTS 3
ARUP Frozen 2 weeks 4 days
AND 4, COMPLEMENT C3
COMPLEMENT COMPONENTS 3
ARUP Frozen 2 weeks 4 days
ABS 4, COMPLEMENT 4

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Testing
Test Temperature Stability TAT
location
Complement Activity, Total EIA ARUP Frozen 2 weeks 4 days
QUANTIFERON PLUS TB PANEL US, EU, SG Refrigerated 4 weeks 7 days
Hematology Panel US, EU, SG Ambient 3 days 1 day
Urinalysis Macro & Micro Panel US, EU, SG Ambient 5 days 1 day
CALPROTECTIN (Fecal) US, EU Refrigerated 18 days 7 days
CALPROTECTION (Fecal)
US, EU, SG Refrigerated 18 days 2 days
EXTRACTION
Microbiology, Stool Culture ID US, EU Refrigerated 4 days 8 days
Ova and Parasites (ARUP) ARUP Refrigerated 9 months 10 days
Clostridium difficile Toxin A/B US, EU Frozen 1 week 4 days
3. Sample Management Samples:
Shipment Frequency to
Sample Name Storage Temp Storage Location
PPD GCL
- If stored at -70˚C: Monthly

- If stored at -20˚C: Weekly
PK (timepoint) Primary and Back-
-70˚C PPD
up Primary and Back-up Samples to
be shipped separately.
- If stored at -70˚C: Monthly

- If stored at -20˚C: Weekly
Immuno ADA Aliq 1 and Aliq ADA 1 and Nab 1 (primaries)

should be shipped together. -70˚C PPD
2/Immuno Nab Aliq 1 and Aliq 2
ADA 2 and Nab 2 (back-ups)
should be shipped together in the
next separate shipment.
Notes:
• If the testing is not performed at the laboratory of receipt, transit time to the testing laboratory
will increase the turnaround time.
• Whole blood samples are retained 7 days after testing. All other samples are retained 10 business
days after testing.

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APPENDIX II REFERENCE RANGES

Panel/Test Type Gender/Age Conventional Units Conventional Low Conventional High SI Units SI Low SI High Non-numeric
C Reactive Protein REFERENCE All mg/L 5.0 nmol/L 47.6
Calprotectin (fecal) REFERENCE All microgram/gram 50
Chemistry Panel / ALT REFERENCE Female / >=18 U/L 10 33 U/L 10 33
YEARS-<=125
YEARS
Chemistry Panel / ALT REFERENCE Male / >=18 U/L 10 40 U/L 10 40
YEARS-<=125
YEARS
Chemistry Panel / AST REFERENCE Female / >=18 U/L 10 36 U/L 10 36
YEARS-<=125
YEARS
Chemistry Panel / AST REFERENCE Male / >=18 U/L 10 43 U/L 10 43
YEARS-<=125
YEARS
Chemistry Panel / Albumin REFERENCE All / >=18 g/dL 3.5 5.5 g/L 35 55
YEARS-<=125
YEARS
Chemistry Panel / Alkaline Phosphatase REFERENCE Female / >=18 U/L 30 115
YEARS-<=125
YEARS
Chemistry Panel / Alkaline Phosphatase REFERENCE Male / >=18 U/L 43 115
YEARS-<=125
YEARS
Chemistry Panel / BUN REFERENCE All / >=18 mg/dL 5 20 mmol/L 1.78 7.14
YEARS-<=125
YEARS
Chemistry Panel / Bilirubin, Direct REFERENCE All / >=18 mg/dL 0 0.4 mcmol/L 0.0 6.8
YEARS-<=125
YEARS
Chemistry Panel / Bilirubin, Total REFERENCE All / >=18 mg/dL 1.1 mcmol/L 18.8
YEARS-<=125
YEARS
Chemistry Panel / Calcium REFERENCE All / >=18 mg/dL 8.5 10.5 mmol/L 2.12 2.62
YEARS-<=125
YEARS
Chemistry Panel / Calcium VOICE ALERT All mg/dL 6.1 12.9 mmol/L 1.52 3.22
Chemistry Panel / Chloride REFERENCE All / >=18 mEq/L 95 110 mmol/L 95 110
YEARS-<=125
YEARS
Chemistry Panel / Cholesterol, Total REFERENCE All / >=18 mg/dL 125 200 mmol/L 3.24 5.18
YEARS-<=125
YEARS
Chemistry Panel / Creatine Phosphokinase REFERENCE Female / >=18 U/L 24 169 U/L 24 169
(CPK) YEARS-<=125
YEARS
Chemistry Panel / Creatine Phosphokinase REFERENCE Male / >=18 U/L 24 207 U/L 24 207
(CPK) YEARS-<=125
YEARS
Chemistry Panel / Creatine Phosphokinase VOICE ALERT All U/L 2000 U/L 2000
(CPK)
Chemistry Panel / Creatinine REFERENCE All / >=18 mg/dL 0.7 1.4 mcmol/L 62 124
YEARS-<=125
YEARS

Page 44 of 64
Chemistry Panel / Gamma Glutamyl Transferase REFERENCE Female / >=18 U/L 5 32 U/L 5 32
YEARS-<=125
YEARS
Chemistry Panel / Gamma Glutamyl Transferase REFERENCE Male / >=18 U/L 10 49 U/L 10 49
YEARS-<=125
YEARS
Chemistry Panel / Glucose, Random REFERENCE All<=125 mg/dL 71 138 mmol/L 3.94 7.66
YEARS
Chemistry Panel / Glucose, Random VOICE ALERT All mg/dL 40 450 mmol/L 2.22 24.98
Chemistry Panel / Lactate Dehydrogenase REFERENCE Female / >=18 U/L 135 330 U/L 135 330
YEARS-<=125
YEARS
Chemistry Panel / Lactate Dehydrogenase REFERENCE Male / >=18 U/L 135 281 U/L 135 281
YEARS-<=125
YEARS
Chemistry Panel / Phosphorous REFERENCE All / >=19 mg/dL 2.5 4.5 mmol/L 0.81 1.45
YEARS-<=125
YEARS
Chemistry Panel / Phosphorous REFERENCE Female / >=16 mg/dL 2.5 4.8 mmol/L 0.81 1.55
YEARS-<=18
YEARS
Chemistry Panel / Phosphorous REFERENCE Male / >=16 mg/dL 2.7 4.9 mmol/L 0.87 1.58
YEARS-<=18
YEARS
Chemistry Panel / Potassium REFERENCE All / >=18 mEq/L 3.5 5.0 mmol/L 3.5 5.0
YEARS-<=125
YEARS
Chemistry Panel / Potassium VOICE ALERT All mEq/L 2.8 6.3 mmol/L 2.8 6.3
Chemistry Panel / Protein REFERENCE All / >=18 g/dL 6.0 8.0 g/L 60 80
YEARS-<=125
YEARS
Chemistry Panel / Sodium REFERENCE All / >=18 mEq/L 133 145 mmol/L 133 145
YEARS-<=125
YEARS
Chemistry Panel / Sodium VOICE ALERT All mEq/L 117 160 mmol/L 117 160
Chemistry Panel / Triglyceride REFERENCE All / >=1 mg/dL 38 243 mmol/L 0.43 2.75
YEARS-<=20
YEARS
Chemistry Panel / Triglyceride REFERENCE All / >=21 mg/dL 45 200 mmol/L 0.51 2.26
YEARS-<=125
YEARS
Clostridium difficile Toxin A/B REFERENCE All - Negative
Complement Activity, Total EIA REFERENCE All CAE Units 60 144
Complement Components 3 and 4, Complement REFERENCE All / >=18 mg/dL 88 201
C3 YEARS-<=125
YEARS
Complement Components 3 and 4, Complement REFERENCE All / >=18 mg/dL 10 40
C4 YEARS-<=125
YEARS

Page 45 of 64
Creatine Phosphokinase, MB REFERENCE Female ng/mL 5.3
Creatine Phosphokinase, MB REFERENCE Male ng/mL 10.4
Creatinine Clearance (Estimated by Weight) REFERENCE All<=18 ml/min 70 140
YEARS
Creatinine Clearance (Estimated by Weight) REFERENCE Female / >=19 ml/min 75 115
YEARS-<=125
YEARS
Creatinine Clearance (Estimated by Weight) REFERENCE Male / >=19 ml/min 85 125
YEARS-<=125
YEARS
HCG(Pre-menopausal) REFERENCE Female mIU/mL 1.0 IU/L 1
HCG(Post-Menopausal) REFERENCE Female mIU/mL 7.0 IU/L 7
HCG(All) REFERENCE Female mIU/mL 7.0 IU/L 7
HCG REFERENCE All - - Negative
HCG VOICE ALERT All - - Negative,Inconclusive
HDL REFERENCE All / >=18 mg/dL 40 60 mmol/L 1.04 1.55
YEARS-<=125
YEARS
Hematology Panel / Basophils REFERENCE All / >=18 % 0.0 3.0 % 0.0 3.0
YEARS-<=125
YEARS
Hematology Panel / Eosinophils REFERENCE All<=125 % 0.0 7.0 % 0.0 7.0
YEARS
Hematology Panel / Hematocrit REFERENCE Female / >=18 % 33.0 47.0 L/L 0.330 0.470
YEARS-<=125
YEARS
Hematology Panel / Hematocrit REFERENCE Male / >=18 % 37.0 51.0 L/L 0.370 0.510
YEARS-<=125
YEARS
Hematology Panel / Hematocrit VOICE ALERT All % 18.0 60.0 L/L 0.180 0.600
Hematology Panel / Hemoglobin REFERENCE Female / >=18 g/dL 11.0 15.5 g/L 110 155
YEARS-<=125
YEARS
Hematology Panel / Hemoglobin REFERENCE Male / >=18 g/dL 12.5 17.0 g/L 125 170
YEARS-<=125
YEARS
Hematology Panel / Hemoglobin VOICE ALERT All g/dL 8.0 22.0 g/L 80 220
Hematology Panel / Immature Granulocyte REFERENCE All / >=18 % 0.0 1.0 % 0.0 1.0
YEARS-<=125
YEARS
Hematology Panel / Lymphocytes REFERENCE All / >=18 % 12.0 46.0 % 12.0 46.0
YEARS-<=125
YEARS

Page 46 of 64
Hematology Panel / MCH REFERENCE All / >=18 pg 27.0 34.0 pg 27.0 34.0
YEARS-<=125
YEARS
Hematology Panel / MCHC REFERENCE All / >=18 g/dL 31.0 36.0 g/L 310 360
YEARS-<=125
YEARS
Hematology Panel / MCV REFERENCE Female / >=18 fL 82.0 102.0 fL 82.0 102.0
YEARS-<=125
YEARS
Hematology Panel / MCV REFERENCE Male / >=18 fL 78.0 100.0 fL 78.0 100.0
YEARS-<=125
YEARS
Hematology Panel / Monocytes REFERENCE All / >=18 % 0.0 11.0 % 0.0 11.0
YEARS-<=125
YEARS
Hematology Panel / Neutrophils REFERENCE All / >=18 % 34.0 71.0 % 34.0 71.0
YEARS-<=125
YEARS
Hematology Panel / Platelet REFERENCE All<=125 x 10^3/uL 163 375 x 10^9/L 163 375
YEARS
Hematology Panel / Platelet VOICE ALERT All x 10^3/uL 30 900 x 10^9/L 30 900
Hematology Panel / RBC REFERENCE Female / >=18 x 10^6/uL 3.70 5.20 x 10^12/L 3.70 5.20
YEARS-<=125
YEARS
Hematology Panel / RBC REFERENCE Male / >=18 x 10^6/uL 4.63 6.08 x 10^12/L 4.63 6.08
YEARS-<=125
YEARS
Hematology Panel / WBC REFERENCE All / >=18 x 10^3/uL 3.70 11.00 x 10^9/L 3.70 11.00
YEARS-<=125
YEARS
Hematology Panel / WBC VOICE ALERT All x 10^3/uL 2.00 25.00 x 10^9/L 2.00 25.00
Hematology Panel / WBC Differential, Basophils REFERENCE All<18 YEARS x 10^3/uL 0.00 0.10 x 10^9/L 0.00 0.10
Hematology Panel / WBC Differential, Basophils REFERENCE All / >=18 x 10^3/uL 0.00 0.30 x 10^9/L 0.00 0.30
YEARS-<=125
YEARS
Hematology Panel / WBC Differential, REFERENCE All / >=18 x 10^3/uL 0.00 0.80 x 10^9/L 0.00 0.80
Eosinophils YEARS-<=125
YEARS
Hematology Panel / WBC Differential, Immature REFERENCE All / >=18 x 10^3/uL 0.00 0.07 x 10^9/L 0.00 0.07
Granulocytes YEARS-<=125
YEARS
Lymphocytes YEARS-<=125
YEARS
Hematology Panel / WBC Differential, Monocytes REFERENCE All / >=18 x 10^3/uL 0.00 1.20 x 10^9/L 0.00 1.20
YEARS-<=125
YEARS
Neutrophils YEARS-<=125
YEARS
HIV 1&2 REFERENCE All - Negative
HIV 1/2 Confirmation REFERENCE All - Negative
HbsAg Panel / Hepatitis B, Surface Antigen REFERENCE All - Negative
HbsAg Panel / Hepatitis B, Surface Antigen REFERENCE All - Negative
Confirmation
Hepatitis B, Core Antibody, Total REFERENCE All - Negative
Hepatitis B, Surface Antibody Total REFERENCE All - Negative
Hepatitis B, Viral Load DNA (Qualitative) REFERENCE All - Negative
Hepatitis C, Antibody REFERENCE All - Negative
Hepatitis C, Viral Load RNA REFERENCE All - Not Detected

Page 47 of 64
Ova and Parasites REFERENCE All - Negative
Quantiferon Plus TB / Quantiferon TB Plus REFERENCE All - Negative
Troponin I REFERENCE All ng/mL 0.30 mcg/L 0.30
Troponin I VOICE ALERT All ng/mL 0.3 mcg/L 0.30
Urinalysis Macro & Micro Panel / Amorphous REFERENCE All #/HPF Absent
Crystals
Urinalysis Macro & Micro Panel / Bacteria REFERENCE All #/HPF Absent
Urinalysis Macro & Micro Panel / Bilirubin REFERENCE All - - Negative
Urinalysis Macro & Micro Panel / Blood REFERENCE All - Negative
Urinalysis Macro & Micro Panel / Calcium REFERENCE All #/HPF None
Carbonate Crystals
Oxalate Crystals
Phosphate Crystals
Urinalysis Macro & Micro Panel / Cysteine REFERENCE All #/HPF None
Crystals
Urinalysis Macro & Micro Panel / Glucose, Urine REFERENCE All mg/dL Negative
Urinalysis Macro & Micro Panel / Granular Casts REFERENCE All #/LPF None
Urinalysis Macro & Micro Panel / Hyaline Casts REFERENCE All #/LPF None
Urinalysis Macro & Micro Panel / Ketone REFERENCE All mg/dL Negative
Urinalysis Macro & Micro Panel / Leucine REFERENCE All #/HPF None
Crystals
Urinalysis Macro & Micro Panel / Leukocyte REFERENCE All - Negative
Esterase
Urinalysis Macro & Micro Panel / Mucus REFERENCE All - Absent
Urinalysis Macro & Micro Panel / Nitrite REFERENCE All - Negative
Urinalysis Macro & Micro Panel / Protein REFERENCE All mg/dL Negative
Urinalysis Macro & Micro Panel / RBC REFERENCE All #/HPF None,Occasional,1-2
Urinalysis Macro & Micro Panel / Red Blood Cell REFERENCE All #/LPF None
Casts
Urinalysis Macro & Micro Panel / Renal Epithelial REFERENCE All #/HPF None
Cells
Urinalysis Macro & Micro Panel / Specific Gravity REFERENCE All - 1.002 1.035
Urinalysis Macro & Micro Panel / Squamous REFERENCE All #/HPF None
Epithelial Cells
Urinalysis Macro & Micro Panel / Transitional REFERENCE All #/HPF None
Epithelial Cells
Urinalysis Macro & Micro Panel / Triple REFERENCE All #/HPF None
Phosphate Crystals
Urinalysis Macro & Micro Panel / Tyrosine REFERENCE All #/HPF None
Crystals
Urinalysis Macro & Micro Panel / Uric Acid REFERENCE All #/HPF None
Crystals
Urinalysis Macro & Micro Panel / Urobilinogen REFERENCE All mg/dL 1.0,0.2
Urinalysis Macro & Micro Panel / WBC REFERENCE All #/HPF None,Occasional,1-5
Urinalysis Macro & Micro Panel / Waxy Casts REFERENCE All #/LPF None
Urinalysis Macro & Micro Panel / White Blood REFERENCE All #/LPF None
Cell Casts
Urinalysis Macro & Micro Panel / Yeast REFERENCE All - - Absent
Urinalysis Macro & Micro Panel / pH REFERENCE All pH 5.0,8.0,6.0,7.0

Page 48 of 64
APPENDIX III SAMPLE COLLECTION AND PROCESSING INSTRUCTIONS
QUANTIFERON TB GOLD PLUS COLLECTION INSTRUCTIONS
The QuantiFERON –TB Gold Plus (In-tube) assay (QFT Plus) measures the Interferon-γ (IFN- γ) response in
whole blood stimulated with antigen. The kit uses specialized QFT Plus blood collection tubes:
- Nil Control Grey Cap

Order of
- TB Antigen 1 Green Cap
- TB Antigen 2 Yellow Cap
Collection
- Mitogen Control Purple Cap
Blood Collection
1. Blood Collection
If tubes have been stored in the refrigerator, allow them to equilibrate to room temperature before use.
- Collect blood by venipuncture into each of the QFT Plus blood collection tubes in the order Nil, TB-
Antigen and Mitogen.
- As 1 mL tubes draw relatively slow, keep the tube on the needle for 2-3 seconds once the tube appears
to have completed filling – to ensure that the correct volume is drawn.
The black mark on the side of the tubes indicates the 1 mL fill volume. QFT Plus blood collection tubes have
been validated for volumes ranging from 0.8 to 1.2 mL. If the level of blood in any tube is not close to the
indicator line, it is recommended to obtain another blood sample.
2. Mixing tubes
Antigens have been dried into the inner wall of the blood collection tubes so it is essential that the contents of
the tubes be thoroughly mixed with the blood. Thorough mixing will dissolve the heparin, preventing clotting,
and allow re-solubilization of the stimulating antigen.
Immediately after filling the tubes, shake them ten (10) times just firmly enough to make sure that the entire
inner surface of the tube is coated with blood. This will dissolve antigens on the tube walls.
Important note – Tubes should be between 17oC – 25oC at the time of shaking. Over vigorous shaking may
cause gel disruption and could lead to aberrant results.
Processing
1. Preparation
The tubes must be transferred to a cabinet incubator, waterbath or heatblock at 37o C as soon as possible,
and within 16 hours of collection. Do not refrigerate or freeze the blood samples.

Page 49 of 64
- QuantiFERON-TB Gold Plus collection tubes are intended for use at temperatures between 17˚C
(62,2˚F) and 27˚C (80,6˚F). After blood collection, and until incubation, tubes must be maintained
within this temperature range.
- If the blood is not incubated immediately after collection, mixing of the tubes must be repeated
immediately prior to incubation
2. Incubation
The tubes must be incubated in upright position at 37˚C (98˚F) for 16-24 Hours.
3. Centrifugation
The tubes contain a gel plug that separates the plasma from the cells when centrifuged. Incubated tubes may
be held for up to 3 days pre-centrifugation at room temperature.
- Centrifuge tubes at 2000-3000 g (RCF) for 15 minutes

- Plasma in centrifuged tubes is stabile for 4 weeks when stored at 2˚C (35˚F) - 8˚C (46˚F).
Shipment
Send the centrifuged tubes at refrigerated temperature to PPD GCL. The tubes are to be placed in the lower
compartment of the flat box.

Page 50 of 64
ERYTHROCYTE SEDIMENTATION RATE TESTING (ESR)
Supplies for site-based ESR testing
PPD GCL will provide you with following supplies:

- 2 ml EDTA tubes for blood collection, provided in bulk
- Fisherbrand Dispette 2 Commercial ESR Kit which contains filling reservoirs and dispette
graduated pipettes (100 tests)
- Fisherbrand ESR rack (orange) for correct positioning of the graduated pipettes
ESR processing instructions – preparation
1. Shake filling reservoir downwards to force saline to the bottom of the reservoir. Keep upright and
remove cap.
2. Collect 2 ml whole blood in the 2 ml EDTA tube. Mix well. Add 1 ml of the EDTA treated whole
blood. Ensure that the blood mixture reaches the filling line level.
3. Replace cap securely
4. Gently mix by inversion (min 8 times)
5. Ensure that all well-mixed blood returns to the bottom section of the reservoir

Page 51 of 64
ESR processing instructions – processing
6. While holding the filling reservoir with one hand and the Dispette graded pipette with the other
hand positioned at the 180 mm mark, penetrate the cap membrane and stop.
7. Gently continue inserting the Dispette tube to the bottom of the reservoir. Ensure that the level
blood reaches to or beyond the grommet at the zero level. When the Dispette tube is fully
inserted, any extra blood will fill the plugged overflow chamber.
Do not force the Dispette tube down. Gently swirl down, to prevent the blood from rising out of
the back end of the Dispette tube. Try to level the blood up to the Level zero (0) grommet.
ESR processing instructions – reading
8. Place the full Dispette assembly in a leveled stand in the rack.

Ensure that the Dispette tube is at 90˚ degrees one degree to the horizontal
Read result exactly 60 minutes after setting upright. Readings are recorded in
millimeters (mm)
NOTES:
- Make sure that the table, used to place the rack on, is balanced and
vibration-free. Any slight deviation from the 90˚ degrees stand may
increase or decrease the blood flow and can therefore influence the result.
- Do not place the rack in direct sunlight
- Add blood up to filling line level. Adding less or too much blood influences
the saline/whole blood ratio and can therefore influence the result.
- Read result after exactly 60 minutes when placed at vertical position in
the rack. Do not pre-prepare tests for multiple patients at the same time.
Exact reading is essential.
- Each filling reservoir and graded Dispette tube can only be used once.
- Reading should be performed by trained staff.
- Should the result fall between 130 and 155 mm, the exact endpoint may
be obscured by the filling reservoir cap. In this case an estimation may be
made, by reading from the scale of an unused Dispette tube held next to
the test Dispette assembly.

Page 52 of 64
STOOL COLLECTION INSTRUCTIONS
Ova and Parasites and Stool Culture Sample Instructions for Sites
Supplies:
1-Commode Hat with lid – supplied within the applicable kit(s).
1-Bag-Insulated Storage Pack W/2 Gel Wraps – supplied in bulk.
1-Bag-Shopper Bag W/Handle – supplied in bulk.
1-Para-Pak C&S Vial (Orage Cap Tube )– supplied (prelabelled) within the applicable kit(s).
1-Para-Pak O&P Vial (Green Cap Tube) – tube supplied in bulk, label to be applied is within the
applicable kit(s). NOTE: Ensure label is applied before tube is given to the participant.
1. Provide the commode hat with lid, insulated bag, shopper bag, Para-Pak C&S Vial, Para-Pak O&P
Vial and the Stool Collection Instructions for Participant to the patient for at-home collection.
2. Sample should be placed in the preservative vial as soon as possible (no more than 2 hours from
the time it is voided).
3. Patient should refrigerate the sample until sample is returned to the site within 24 hours of
collection.
4. The processing instructions detailed in the Stool Collection Instructions for Participant section may
be performed by site personnel for samples voided at the site.
5. Ship sample to PPD refrigerated on same day of receipt at site to maintain stability.
Calprotectin and C. Difficile Sample Collection Instructions for Sites

Supplies:
1-Commode Hat with lid – supplied within the applicable kit(s).
1-Bag-Insulated Storage Pack W/2 Gel Wraps – supplied in bulk.
1-Shopper Bag with handle – supplied in bulk.
2-Transfer Vial 5mL Fecal Container with Spoon – supplied (prelabelled) within the applicable kit(s).
Procedure:
1. Provide the commode hat with lid, insulated bag, shopper bag and and the Stool Collection
Instructions for Participant to the patient for at-home collection.
2. Patient should refrigerate sample until sample is returned back to site within 24 hours of collection
3. Transfer stool sample, using the stool spoon, into the 5mL transfer vial
a. Preferred amount 2 grams of stool (approximately equal to two full scoops using the narrow end o
f the stool spoon).
b. Minimum amount 0.6 grams of stool.
5. Ship the Calprotectin sample to PPD refrigerated on same day of receipt at site to maintain stability.
6. Ship the C. Difficile sample to PPD frozen on same day of receipt at site to maintain stability.

Page 53 of 64
Stool Collection Instructions for Participant
Dear Study Participant,
You have been provided with the following materials to obtain a stool sample at home:
1 Commode Hat with Lid
1 Insulated bag with 2 gel wraps
1 Para-Pak O&P Preservative Vial (Green Cap)
Shopper Bag with Handle

Page 54 of 64
Please carefully follow the instructions below:
- Place the commode hat on the toilet seat

- Defecate into the commode hat. Do NOT allow urine, water or other material to enter the hat.
- Using the collection spoon provided in the cap of the vial, select an appropriate area of the stool (i.e.,
bloody, slimy, watery) for sampling.
- Add sufficient stool to each orange and green vials within 2 hours from the time it is voided to bring
the liquid level up to the “fill to here” line.
- Mix the specimen with the spoon along the inside surface of the container, replace and tighten the cap
ensuring that it is not cross-threaded.
- Shake the container firmly to ensure the specimen is well-mixed. The solution should appear
homogenous after the mixing is complete.
- Fill in requested information on the attached label and place the Orange Cap and the Green Cap vials
and the commode hat with lid into the shopper bag. These samples should be kept refrigerated until
the sample is placed within the Insulated bag.
- Gel wraps should be frozen in the freezer the day before use.
- Frozen gel wraps should be placed within the Insulated bag together with the shopper bag (containing
the Orange Cap and the Green Cap vials and commode hat with lid before it is returned to site. Stool
samples must be returned to the site no longer than 24 hours after collection. Keep the shopper bag
with the commode hat in the refrigerator until the sample is returned to the site.
Note:
- You should avoid the use of antacids, barium, bismuth, antidiarrheal medication, and oily laxatives
prior to the collection of this specimen.
- The collection process should be performed sequentially, minimizing any delays. The sample should
be no more than 2 hours old from the time it is voided to the time it is placed in the preservative
vials (Orange and Green Cap vials).
- Stool sample must be returned to the site no longer than 24 hours after collection.
Precautions:
- Avoid contact of fixative solution with the skin and eyes. Should contact occur, flush with running
water. If irritation should develop, see a physician.
- Fixative solutions are poisonous. If ingested, dilute by drinking milk or water. Then call local
poison center or physician immediately.
- LV-PVA fixative is corrosive for metals. Keep out of contact with metals. LV-PVA is flammable.
Formalin is a potential cancer hazard.

Page 55 of 64
APPENDIX IV LAB MANUAL CHANGE LOG

Amendments to the Laboratory Manual :
AMENDMENT #: [Enter Amend #]
DATE OF REQUEST: REQUESTED BY:
DESCRIPTION OF CHANGE
CHANGE # :
SECTION :
PAGE:
ORIGINAL VERBIAGE:
UPDATED VERBIAGE:
CHANGE # :
SECTION :
PAGE:
ORIGINAL VERBIAGE:
UPDATED VERBIAGE:
CHANGE # :
SECTION :
PAGE:
ORIGINAL VERBIAGE:
UPDATED VERBIAGE:

Page 56 of 64
Documentation

Page 57 of 64
CURRICULUM VITAE
1. Lab Director PPD Laboratories-US & PPD Laboratories-EU

Page 58 of 64

Page 59 of 64
2. Lab Director PPD Laboratories SINGAPORE

Page 60 of 64
CAP AND CLIA CERTIFICATIONS

• PPD Central Labs certifications are provided in this manual for your site’s reference. As a note,
the most current laboratory certifications are posted and available at http://www.ppdi.com under
the Services / Laboratories / Central Labs / Certifications sub-category. Please file these
certifications where appropriate when the current certifications in your manual expire.
• Regulatory Accreditation Programs are continual processes: a laboratory remains accredited until
otherwise notified. While a certificate provides effective and expiration dates, laboratories remain
accredited while they wait for the receipt of a new certificate, even if the expiration date has
passed. New certificates are posted on the website as soon as they are made available by the
Regulatory/Accrediting Agency.
1. CLIA Certification – PPD Laboratories US

Page 61 of 64
2. CAP Certification – PPD Laboratories US

Page 62 of 64
3. CAP Certification – PPD Laboratories EU

Page 63 of 64
4. CAP Certification – PPD Laboratories Singapore

Page 64 of 64

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Central Laboratory Manual

Template Version GCL-PM-0059r09, Effective 15JUN2017

Template Version GCL-PM-0059r09, Effective 15JUN2017

3 SPECIMEN COLLECTION GUIDE ............................................................................................. 17

4 SAMPLE LABELING & IDENTIFICATION ................................................................................... 20

5 SITE STORAGE OF SAMPLES PRIOR TO SHIPMENT ................................................................... 23

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6 SPECIMEN PROCESSING AT THE CENTRAL LABORATORY ........................................................... 36

STUDY SPECIFIC INFORMATION .................................................................................................... 41

Template Version GCL-PM-0059r09, Effective 15JUN2017

1 INTRODUCTION TO OUR SERVICES

PPD Laboratories – US (for North, South and Latin America):

PPD Laboratories – EU (for Europe, Middle East and Africa):

Clusterpark, Kleine Kloosterstraat 19

PPD Laboratories – SG (for Asia Pacific):

Template Version GCL-PM-0059r09, Effective 15JUN2017

1.2 TOLL FREE PHONE ACCESS

Template Version GCL-PM-0059r09, Effective 15JUN2017

1.3 GLOSSARY OF LAB MANUAL ABBREVIATIONS AND TERMINOLOGY

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1.4 HOLIDAY SCHEDULE

New Year’s Day 01 Jan 2019 01 Jan 2020 01 Jan 2021

Memorial Day 27 May 2019 25 May 2020 31 May 2021

Independence Day 04 Jul 2019 04 Jul 2020 04 Jul 2021

Labor Day 02 Sep 2019 07 Sep 2020 06 Sep 2021

Thanksgiving Day 28 Nov 2019 26 Nov 2020 25 Nov 2021

Christmas Day 25 Dec 2019 25 Dec 2020 25 Dec 2021

PPD Laboratories Europe

New Year’s Day 01 Jan 2019 01 Jan 2020 01 Jan 2021

Easter Monday 22 Apr 2019 13 Apr 2020 05 April 2021

Pentecost Monday 10 Jun 2019 01 Jun 2020 24 May 2021

Christmas Day 25 Dec 2019 25 Dec 2020 25 Dec 2021

PPD Laboratories Singapore

New Year’s Day 01 Jan 2019 01 Jan 2020 01 Jan 2021

Chinese New Year 05 Feb 2019 25 Jan 2020 12 Feb 2021

Christmas Day 25 Dec 2019 25 Dec 2020 25 Dec 2021

Template Version GCL-PM-0059r09, Effective 15JUN2017

1.5 Preclarus® Investigator Site Portal

The portal can be accessed at: http://preclaruslabdata.ppdi.com

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1.5.1 Online Accessioning:

PART 2 Viewing Reports, Supplies, Query Center, and Viewing Documents

1.5.4 Queries Center:

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1.5.8 Change User:

1.5.9 User Management:

1.5.11 Alert Box:

1.5.12 News Ticker:

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1.5.13 Mobile Application:

• For Site Members Only.

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2.1 VISIT-SPECIFIC COLLECTION KITS

Template Version GCL-PM-0059r09, Effective 15JUN2017

2.2 INITIAL SUPPLIES

Template Version GCL-PM-0059r09, Effective 15JUN2017

2.3 RE-ORDERING OF SUPPLIES

Supplies can be reordered in three ways:

2.4 DELIVERY TRANSIT TIMES