MICHELANGELO: OASIS-5
UA/NSTEMI STUDY
(EFC 3197)
An International Randomized Double-Blind Study
Evaluating the Efficacy and Safety of Fondaparinux
Versus Enoxaparin in the Acute Treatment of
Unstable Angina/Non ST-Segment Elevation MI Acute
Coronary Syndromes
Biomarker Substudy
Specimen Collection and Processing
Instructions
August 2003
Hamilton Regional Laboratory Medicine Program
Clinical Research and Clinical Trials Laboratory
STUDY SPONSORS:
OASIS-5 Study
CLINICAL TRIAL LABORATORY PROCEDURES MANUAL
Test Drugs
Fondaparinux
Atrixa®
Principal Investigator
Dr. Shamir Mehta
Trial Coordination
Susan Chrolavicius
Research Assistant
(Primary Contact)
Craig Horsman
Telephone Number: 1 -905-527-4322 Ext. 46424
Fax Number:
1-905-577-1403
e-mail:
craig@ccc.mcmaster.ca
Blood Coordination
(Blood Specimen Shipments)
Rose Mayhew
Telephone Number: 1 -905-527-4322 Ext. 44408
Fax Number:
1-905-527-9642
e-mail:
rose@phri.ca
CENTRAL LABORATORY
Hamilton Regional Laboratory Medicine Program
Clinical Research and Clinical Trials Laboratory
Hamilton General Hospital Site
237 Barton Street East
Hamilton, Ontario, Canada L8L 2X2
Dr. Matthew J. McQueen
Director, Clinical Trials Laboratory
Professor, Department of Pathology and Molecular Medicine
McMaster University
Contact information for Central Laboratory questions:
Telephone: 1-905-527-4322 x 44259
Fax:
1-905-577-1476
e-mail:
hallkim@hhsc.ca; keys@hhsc.ca
Kim Hall, Research Coordinator 1-905-527-4322 x 46149
Judy Keys, Research Coordinator 1-905-527-4322 x 46161
2
Table of Contents
1.0
Collection of Specimens for Local Laboratory Analysis
1
2.0
Specimen Collection Supplies for Central Laboratory Analysis
1
2.1
Central Laboratory Specimen Collection Kits
2.1.1
2.1.2
3.0
The Bulk Supply Kit
2
2.3
Additional Laboratory Supplies
2
2.4
Provision of Central Laboratory Supplies
3
2.5
Request for Resupply of Central Laboratory Supplies
3
2.6
OASIS-5 Specimen Labels & Instructions for Use
3
Collection of Specimens for Central Laboratory Analysis
Baseline OASIS -5 Central Laboratory Specimen Collection
3.1.1
3.1.2
3.1.3
3.2
Preparation for Baseline Central Laboratory Specimen Collection
Baseline Specimen Collection for Central Laboratory Analysis
Documentation of the Baseline Specimen Collection
Central Laboratory Specimen Collection at 6, 24 and 72 hours after
Randomization
3.2.1
3.2.2
3.2.3
7
8
8
8
9
10
Preparation for Post-Randomization Central Laboratory Specimen
Collection
10
Specimen Collection for Central Laboratory Analysis at 6, 24 and 72
Hours after Randomization
10
Documentation of each Post-Randomization Specimen Collection 11
Processing of Central Laboratory Specimens
12
4.1
Processing the Specimens from the Baseline Collection
12
Processing the 10 mL RED top tube
Processing the 4 mL LAVENDER top tubes
Processing the 2.7 mL BLUE top tubes
12
13
14
4.1.1
4.1.2
4.1.3
4.2
1
1
1
2.2
3.1
4.0
Baseline Specimen Collection Kits
6, 24 and 72 hour Post-Randomization Specimen Collection Kits
1
Processing the Specimens Collected at 6, 24 and 72 hours After
Randomization
15
4.2.1 Processing the 5 mL RED top tube
4.2.2 Processing the 4 mL LAVENDER top tube
15
16
4.3
4.2.3 Processing the 2.7 mL BLUE top tubes
16
The Blood Log Form CRF1A and Freezer Instruction Sheet
18
5.0
Handling and Storage of Central Laboratory Specimens
19
6.0
Preparing Blood Specimens for Shipment
19
6.1
Packing and Shipping Material Required
20
6.2
Packing Dry Ice Boxes With Blood Specimens
20
6.2.1
6.2.2
6.2.3
7.0
Sites Outside North America shipping to local National Storage
Site
North American Sites shipping to Central Lab, Canada
All Sites
20
21
21
Completion of Shipment Documentation
21
7.1
21
Study Sites Outside North America shipping to National Storage Site
7.1.1
7.1.2
7.1.3
7.2
North American Study Sites
7.2.1
7.2.2
7.2.3
7.3
Commercial Invoice (CI) – Not required
Air Waybill (AWB)
Notice of Shipment From Study Site to National Storage Site
21
21
22
22
Commercial Invoice (CI) To be completed by USA sites – not required
for Canadian Sites
22
Air Waybill (AWB)
23
Notice of Shipment From Study Site to Central Laboratory
23
National Storage Sites Outside North America
24
8.0
Finalization of Shipment & S hipment Forms
24
9.0
Fax the Blood Log Form(s) at the Time of Shipment
24
Contents of Appendix A:
Sample OASIS-5 Request for Central Laboratory Supplies Fax Form
Sample Notice of Shipment form (ShipForm1)
Sample Notice of Shipment to National Storage Site form
OASIS-5 Flow Chart for Processing of Baseline Blood Samples
OASIS-5 Flow Chart for Processing of Specimens Collected at 6, 24 and 72 hours After
Randomization
Sample Blood Log form CRF1A
Sample Blood Log form CRF1A Freezer Instruction Sheet
2
1.0 Collection of Specimens for Local Laboratory
Analysis
Supplies for local laboratory collection and analysis must be obtained locally by
each study site.
2.0 Specimen Collection Supplies for Central
Laboratory Analysis
Blood for central laboratory analysis will be drawn at Baseline for each patient
participating in the Biomarker Substudy. In a subset of patients, additional blood
for central laboratory analysis will also be drawn at 6, 24 and 72 hours after
randomization. Central laboratory specimens will be evaluated for coagulation
markers including: fibrinogen, von willebrand factor, D-dimers, thrombinantithrombin complexes, clotting factors, plasminogen activator inhibitor-1,
fibrinopeptide A, prothrombin fragment 1+2, and thrombin precursor protein.
Inflammatory markers will include but not be limited to: sCD40 Ligand, cytokines
including interleukins, cell adhesion molecules, high sensitivity C reative protein,
and pregnancy associated plasma protein (PAPP). Markers of cell injury and
plaque rupture will also be assayed, including troponin, myoglobin, creatine
kinase, N-terminal pro brain natiuretic peptide (pro-BNP), and brain natiuretic
peptide (BNP).
2.1 Central Laboratory Specimen Collection Kits
Specimen Collection Kits have been prepared for individual subjects and
are conveniently packaged in individual resealable plastic bags.
2.1.1 Baseline Specimen Collection Kits
Each individual Baseline Specimen Collection Kit contains:
1 set of 17 barcode labels
1x10 mL red Vacutainer collection tube
2x4 mL lavender (EDTA) Vacutainer collection tubes
2x2.7 mL blue (citrate) Vacutainer collection tubes
8 disposable plastic pipettes
1 resealable plastic kit bag
1x5 mL polystyrene centrifuge tube with cap
1 needle
1 bandaid
1 cotton ball
1 alcohol wipe
1 absorbent strip
9x2 mL transfer vials
2.1.2 6, 24 and 72 hour Post-Randomization Specimen Collection
Kits
One Post-Randomization kit will be needed for blood collection at 6 hours,
a second kit at 24 hours and a third kit at 72 hours Post-Randomization.
1
The contents of the kits for the three post-Randomization blood draws are
identical except for the unique barcode labels provided in each kit.
Each individual Post-Randomization Specimen Collection Kit contains:
1 set of 13 barcode labels
1x5 mL red Vacutainer collection tube
1x4 mL lavender (EDTA) Vacutainer collection tubes
2x2.7 blue mL (Citrate) Vacutainer collection tubes
6 disposable plastic pipettes
1 resealable plastic kit bag
1x5 mL polystyrene centrifuge tube with cap
1 needle
1 bandaid
1 cotton ball
1 absorbent strip
1 alcohol wipe
6x2 mL transfer vials
Do not interchange supplies between Specimen Collection Kits.
If additional blood kit supplies are needed due to breakage or missing
components, take the item needed from the Bulk Supply Kit provided.
2.2 The Bulk Supply Kit
In addition to individual Specimen Collection Kits, each center is supplied
with one Bulk Supply Kit in a large resealable plastic bag. This contains
supplies to set up the specimen collection station, as well as extra kit
supplies to replace any component of an individual Specimen Collection
Kit. The Bulk Supply Kit contains:
3 barrels
3 tourniquets
5x10 mL red collection tubes
5 needles
5x4 mL lavender collection tubes
5 alcohol wipes
5x2.7 mL blue collection tubes
5 cotton balls
5x5 mL red collection tubes
5 bandaids
10 plastic pipettes
10x2 mL transfer vials
5x5 mL polystyrene centrifuge tubes with caps 5 absorbent strips
2.3 Additional Laboratory Supplies
The following have been supplied to each site:
• OASIS-5 Specimen Collection and Processing Instructions (in
OASIS-5 Study Binder)
• 10 OASIS-5 Request for Resupply Fax Form—sample in
Appendix A
• Dry Ice Shipment Boxes (containing initial shipment of blood
collection kits in styrofoam inserts—do not discard these boxes or
the papers in the bottom)
• 1 Pad of CRF 1A Blood Log Forms for laboratory use -- sample in
Appendix A
2
•
•
CRF 1A Freezer Instruction Sheet: post on freezer where
specimens are stored -- sample in Appendix A
Documentation and material for shipment to Project Office (North
American sites only)
2.4 Provision of Central Laboratory Supplies
Each center will receive Central Laboratory Supplies in wax shipping
boxes with styrofoam liners at the beginning of the study. Each shipment
will contain 20 Baseline Specimen Collection Kits in individual resealable
bags (20 patients-1 kit per patient) and 18 Post-randomization Specimen
Collection Kits in individual resealable bags (6 patients-3 kits per patient).
Do not discard these boxes or the paperwork in the bottom, as they
will be used to ship frozen specimens to the Central Laboratory or
National Storage Site.
On receipt of Central Laboratory supply shipments, please compare the
contents to the packing slip(s) and immediately report any missing items
to the CCC Project Office.
2.5 Request for Resupply of Central Laboratory Supplies
Please assess the rate at which you are screening participants and allow
as much lead-time as possible for the CCC Project Office to send
additional boxes of supplies. Additional supplies are requested using the
Request for Resupply Fax Form in Appendix A. Please complete the
information for your site , indicate the supplies needed and then fax the
form to the number printed on the form.
2.6 OASIS-5 Specimen Labels & Instructions for Use
Each set of blood labels is preprinted with a unique barcode number and a
brief description for the use of each individual label. The labels have an
adhesive backing for application to the CRFs, collection tubes, and
transfer vials prior to specimen collection and processing. For quick
reference, general instructions for use of the labels at the Baseline
collection are given in Table 1, and instructions for use of the labels at the
Post-Randomization collections are given in Table 2.
DO NOT MIX barcode labels between kits—use all those provided in
an individual Specimen Collection Kit for ONE SUBJECT at ONE
COLLECTION TIME.
3
Table 1: Labels for Baseline OASIS-5 Specimen Collection
Instructions
OASIS-5 Label
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
10 ml red
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
4 ml lavender
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
4 ml lavender
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
2.7 ml blue
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
2.7 ml blue
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
subject CRF
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
serum (red)
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
serum (red)
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
serum (red)
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
buffy coat
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
buffy coat
4
•
use on 10 mL RED vacutainer tube for collecting blood
•
use on 4 mL LAVENDER vacutainer tube for collecting blood
•
use on 4 mL LAVENDER vacutainer tube for collecting blood
•
use on 2.7 mL BLUE vacutainer tube for collecting blood
•
use on 2.7 mL BLUE vacutainer tube for collecting blood
•
apply to CRF 3 in the space indicated
•
use on orange capped transfer vial for 1.5 mL of serum from
the 10 mL RED top tube
•
use on orange capped transfer vial for 1.5 mL of serum from
the 10 mL RED top tube
•
use on orange capped transfer vial for 1.5 mL of serum from
the 10 mL RED top tube
•
use on orange capped transfer vial which has been filled with
buffy coat from one 4 mL LAVENDER top tube ONLY IF THE
SUBJECT SIGNED THE CONSENT FOR THE GENETICS
COMPONENT OF THE BIOMARKER SUBSTUDY
use on orange capped transfer vial which has been filled with
buffy coat from one 4 mL LAVENDER top tube ONLY IF THE
SUBJECT SIGNED THE CONSENT FOR THE GENETICS
COMPONENT OF THE BIOMARKER SUBSTUDY
•
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
plasma(lavender)
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
plasma(lavender)
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
plasma(blue )
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
plasma(blue)respin
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
plasma(blue)spun2x
OASIS-5
_________________
patient ID
3300001
blood log
Table 2:
•
use on orange capped transfer vial for 1.5 mL of serum from
the 4 mL LAVENDER top tube
•
use on orange capped transfer vial for 1.5 mL of serum from
the 4 mL LAVENDER top tube
•
use on orange capped transfer vial for 1.5 mL of plasma from
the 2.7 mL BLUE top tube
•
use on 5 mL polystyrene tube to respin the plasma aliquotted
from one of the 2.7 mL BLUE top tubes
•
use on orange capped transfer vial for 1.5 mL of plasma
transferred from the 5 mL centrifuge tube after the second spin
•
•
•
clearly print patient ID on the line with black pen
place label on space indicated on the Blood Log CRF 1A
print barcode and patient ID numbers onto the adjacent fields
on the Blood Log CRF 1A
Labels for Post-Randomization OASIS-5 Specimen
Collection
Instructions
OASIS-5 Label
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
5 ml red
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
2.7 mL blue
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
2.7 mL blue
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
4 mL lavender
5
•
use on 5 mL RED vacutainer tube for collecting blood
•
use on 2.7 mL BLUE vacutainer tube for collecting blood
•
use on 2.7 mL BLUE vacutainer tube for collecting blood
•
use on 4 mL LAVENDER vacutainer tube for collecting
blood
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
subject CRF
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
serum(red)
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
serum(red)
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
plasma(blue)
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
plasma(blue)respin
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
plasma(blue)spun2x
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
plasma(lavender)
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
plasma(lavender)
OASIS-5
_________________
patient ID
3300001
blood log
6
•
apply to CRF 7D in the space specified for the 6 hour OR
24 hour OR 72 hour Post-Randomization specimen
•
use on orange capped transfer vial for 1.0 mL of serum from
the 5 mL RED top tube
•
use on orange capped transfer vial for 1.0 mL of serum from
the 5 mL RED top tube
•
use on orange capped transfer vial for 1.5 mL of plasma
from the 2.7 mL BLUE top tube
•
use on 5 mL polystyrene tube to respin the plasma
aliquotted from one of the 2.7 mL BLUE top tubes
•
use on orange capped transfer vial for 1.5 mL of plasma
transferred from the 5 mL centrifuge tube after the second
spin
•
use on orange capped transfer vial for 1.0 mL of serum from
the 4 mL LAVENDER top tube
•
use on orange capped transfer vial for 1.0 mL of serum from
the 4 mL LAVENDER top tube
•
•
•
clearly print patient ID on the line with black pen
place label on space indicated on the Blood Log CRF1A
print barcode and patient ID numbers onto the adjacent
fields on the Blood Log CRF1A
Please Note: All barcode labels must be applied along the long axis of
each transfer vial
OASIS-5
3300001
plasma
(blue)
OASIS-5
3300001
plasma (blue)
3.0 Collection of Specimens for Central Laboratory
Analysis
All consenting participants will have a blood specimen drawn at Baseline (BEFORE the
study drug has been administered). A subset of all Baseline participants will also have 6
hour, 24 hour and 72 hour Post-Randomization specimens drawn.
For central lab Baseline specimen collection, 23.4 mL of blood will be collected into 5
vacutainer tubes for each OASIS -5 patient. Processing of these specimens will result in
9 transfer vials (7 transfer vials if subject has not consented to the genetics component of
the biomarker substudy).
For central lab Post-Randomization specimen collection, 14.4 mL of blood will be
collected into 4 vacutainer tubes at each of 6 hours, 24 hours and 72 hours PostRandomization for each OASIS -5 patient. Processing of these specimens will result in 6
transfer vials at each of the three times.
Blood must be centrifuged, separated and frozen within 2 hours of collection.
Blood specimens must be stored frozen at -70ºC (preferred) or -20ºC (acceptable) at
each study site until shipped on dry ice to the National Storage Site or to the Central
Laboratory in Canada (North American sites only).
Frozen specimens will be shipped every 3 months to the National Storage Site or
Central Laboratory on Dry Ice. Specimens will be stored at the Hamilton Regional
Laboratory Medicine Program (Central Lab), to be assayed at a future date for various
analyses.
7
3.1 Baseline OASIS-5 Central Laboratory Specimen
Collection
3.1.1 Preparation for Baseline Central Laboratory Specimen
Collection
•
use one specimen collection kit per participant
•
check the expiry dates on the vacutainer tubes before collecting blood;
if the tubes have expired, discard them and contact Rose Mayhew at
the CCC Project Office immediately for replacement OASIS -5 tubes
(rose@phri.ca; (905) 527-4322 Ext. 44408)
•
do not substitute another brand of collection tube; replacements for
expired tubes must be provided by the Central Laboratory
•
prepare the five blood collection tubes by affixing the barcode labels to
each tube before collecting specimens from the subject
•
match the colour and volume written on each label to the collection
tube stopper colour and volume
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
10 mL red
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
2.7 mL blue
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
4 mL lavender
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
2.7 mL blue
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
4 mL lavender
3.1.2 Baseline Specimen Collection for Central Laboratory Analysis
•
using the vacutainer, barrel and needle supplied in the Specimen
Collection Kit, draw the 5 blood collection tubes using aseptic
technique
Blood tubes MUST be drawn in the following order:
1.
2.
3.
4.
8
1 x 10 mL red top tube
2 x 2.7 mL blue top tube
2 x 4 mL lavender top tube
blood for local measurements which will be assayed locally
•
remove tourniquet as soon as blood flow into the first vacutainer tube
is established; excessive use of tourniquets can lead to
hemoconcentration and falsely elevated results
•
ensure each vacutainer is full to provide accurate blood:additive
ratios
•
mix blood tubes by gently inverting each tube 5 times
•
on the “blood log” barcode label, clearly print the patient ID number on
the line with black pen
•
•
OASIS-5
___________________
patient ID
3300001
blood log
return the 5 full blood collection tubes and sheet of labels to the
resealable Specimen Collection Kit bag containing the remaining
supplies
if specimens are to be processed by the local laboratory, arrange
prompt pick up by, or delivery to, the local laboratory since blood must
be processed and frozen within 2 hours of collection
3.1.3 Documentation of the Baseline Specimen Collection
•
apply the “subject CRF” label to the space indicated on CRF 3 for the
subject
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
subject CRF
9
•
this label provides a permanent record of the collection of Baseline
OASIS-5 specimens for central laboratory analysis, links the barcode
number on the central laboratory specimens to the OASIS -5 subject ID
number, and confirms the date collected and quantity of specimens for
the subject
•
ensure the barcode number matches the labels on the transfer vials
•
enter the date of specimen collection on the CRF for the current visit
•
confirm the barcode number printed on the bottom of the label by
copying this number in the space provided for “Blood Label No.” on
the CRF for the current visit
3.2 Central Laboratory Specimen Collection at 6, 24 and 72
Hours After Randomization
3.2.1 Preparation for Post-Randomization Central Laboratory
Specimen Collection
•
use one specimen collection kit per participant
•
check the expiry dates on the vacutainer tubes before collecting blood;
if the tubes have expired, discard them and contact Rose Mayhew at
the CCC Project Office immediately for replacement OASIS -5 tubes
(rose@phri.ca; (905) 527-4322 Ext. 44408)
•
do not substitute another brand of collection tube; replacements for
expired tubes must be provided by the Central Laboratory
•
prepare the four blood collection tubes by affixing the barcode labels to
each tube before collecting specimens from the subject
•
match the colour and volume written on each label to the collection
tube stopper colour and volume
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
5 mL red
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
2.7 mL blue
OASIS-5
lllllllllllllllllllllllllllllllllllllllllll
3300001
4 mL lavender
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
2.7 mL blue
3.2.2 Post-Randomizaton Specimen Collection for Central
Laboratory Analysis
•
10
using the vacutainer, barrel and needle supplied in the Specimen
Collection Kit, draw the four blood collection tubes using aseptic
technique
Blood tubes MUST be drawn in the following order:
1)
2)
3)
4)
1 x 5 mL red top Tube
2 x 2.7 mL blue top Tube
1 x 4 mL lavender top Tube
blood for local measurements which will be assayed
locally
•
remove tourniquet as soon as blood flow into the first vacutainer tube
is established; excessive use of tourniquets can lead to
hemoconcentration and falsely elevated results
•
ensure each vacutainer is full to provide accurate blood:additive
ratios
•
mix blood tubes by gently inverting each tube 5 times
•
on the “blood log” barcode label, clearly print the patient ID number on
the line with black pen
OASIS-5
__________________
patient ID
3300001
blood log
•
return the 4 full blood collection tubes and sheet of labels to the
resealable Specimen Collection Kit bag containing the remaining
supplies
•
if specimens are to be processed by the local laboratory, arrange
prompt pick up or delivery to the local laboratory as blood must be
processed and frozen within 2 hours of collection
3.2.3 Documentation of each Specific Post-Randomization
Specimen Collection
•
apply the “subject CRF” label to the space indicated on CRF 7D for the
subject in the section matching the time (6 hours OR 24 hours OR
72 hours Post-Randomization) for the specimen you collected
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
subject CRF
•
11
this label provides a permanent record of the collection of each timespecific Post-Randomization OASIS -5 specimen for central laboratory
analysis, links the barcode number on the central laboratory
specimens to the OASIS -5 subject ID number, and confirms the date
collected and quantity of specimens for the subject
•
ensure the barcode number matches the labels on the transfer vials
•
enter the date of specimen collection on the CRF for the current visit
•
confirm the barcode number printed on the bottom of the label by
copying this number in the space provided for “Blood Label No.” on
CRF 7D
4.0 Processing of Central Laboratory Specimens
•
most centres will use the services of a local laboratory for specimen processing
•
ensure laboratory has been provided with the “CRF1A Freezer Instruction Sheet”
for posting on the freezer where the OASIS -5 samples will be frozen and stored
•
ensure the laboratory has been provided with the pad of CRF1A Blood Log Forms
•
DO NOT collect blood in an office and ship it to the laboratory at ambient
temperature or on ice prior to separation
•
the time between drawing the blood specimen to freezing the specimens
MUST NOT exceed two hours
•
if there is a delay in processing, the tubes containing blood should be stored in
the refrigerator for a maximum of one hour
•
for quick reference, specimen processing flow charts for each of the BASELINE
and POST-Randomization collections can be found in Appendix A
•
use a new transfer pipette for transferring from each vacutainer tube into the
transfer vials; an adequate number of transfer pipettes are provided in each kit
4.1 Processing the Specimens from the Baseline Collection
4.1.1 Processing the 10 mL RED top tube
12
•
after filling the tubes, let the tubes stand at room temperature until a
clot has formed in the RED top tube (approximately 30 minutes)
•
centrifuge the tube at 1500 g (3000 rpm) with the LAVENDER and
BLUE collection tubes for 15 minutes until the serum and the cells
are well separated
•
label 3 transfer vials lengthwise with the appropriate barcode labels
indicating “serum (red)”
OASIS-5
OASIS-5
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll llllllllllllllllllllllllllllllllllllllllllll llllllllllllllllllllllllllllllllllllllllllll
3300001
3300001
3300001
serum (red)
serum (red)
serum (red)
•
ensure the barcode number matches the label on the RED
collection tube
•
transfer 1.5 to 2.0 mL of serum into each of the 3 labelled transfer
vials labelled “serum (red)”
4.1.2 Processing the 4 mL LAVENDER top tubes
•
centrifuge the tubes with the other collection tubes at 1500 g (3000
rpm) for 15 minutes
•
apply the barcode labels indicating “plasma(lavender)” lengthwise
to two of the transfer vials
OASIS-5
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll llllllllllllllllllllllllllllllllllllllllllll
3300001
3300001
plasma(lavender)
plasma(lavender)
•
apply the barcode labels indicating “buffy coat” lengthwise to two of
the transfer vials ONLY IF THE SUBJECT SIGNED THE
CONSENT FOR THE GENETICS COMPONENT OF THE
BIOMARKER SUBSTUDY
OASIS-5
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll llllllllllllllllllllllllllllllllllllllllllll
3300001
3300001
buffy coat
buffy coat
Please Note: All barcode labels must be applied along the long axis of
each transfer vial
•
13
ensure the barcode number matches the label on the LAVENDER
collection tube
•
transfer 1.5 to 2.0 mL of plasma from each of the collection tubes
into each of the transfer vials labelled “plasma (lavender)”
•
IF THE SUBJECT SIGNED THE CONSENT FOR THE GENETICS
COMPONENT OF THE BIOMARKER SUBSTUDY, after removal of
the plasma from each tube, carefully draw the thin layer of white
cells (lying on top of the red cells) from one tube into a transfer
pipette and transfer into one transfer vial labelled “buffy coat”;
repeat for the second tube, using a fresh pipette
Note: It does not matter if some red cells are transferred with the
white cells. There will be a small volume of buffy coat in the transfer
vial on completion.
4.1.3 Processing the 2.7 mL BLUE top tubes
•
centrifuge the tubes at 1500 g (3000 rpm) with the other collection
tubes for 15 minutes until the plasma and the cells are well
separated
•
label the 5 mL centrifuge tube with the label provided indicating
“plasma (blue) respin”
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
plasma(blue)respin
•
label 2 transfer vials lengthwise with the barcode labels indicating
“plasma (blue)” and “plasma (blue) spun2x”
•
ensure the barcode number matches the label on the BLUE
collection tubes
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
plasma(blue)
14
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
plasma(blue)spun2x
•
transfer the plasma from one of the 2.7 mL BLUE tubes into the 5
mL centrifuge tube labelled “plasma (blue) respin”
•
centrifuge the polystyrene tube at 1500 g (3000 rpm) for 15 minutes
•
while the plasma from the first tube is being spun again, transfer
1.5 to 2.0 mL of plasma from the second BLUE tube into the
transfer vial labelled “plasma (blue)”
•
once the 5 mL centrifuge tube has finished the second
centrifugation, carefully remove the plasma with a new pipette,
leaving a small volume in the bottom of the tube; transfer the
plasma in the pipette to the transfer vial labelled “plasma (blue)
spun2x”
•
return the 9 labelled blood specimen aliquots (or 7 for subjects who
did NOT consent to the genetics component of the biomarker
substudy) to the resealable Blood Specimen Collection Kit bag
•
the absorbent strip (small piece of white cotton cloth) must remain
in the bag to absorb moisture
•
eliminate the air from the plastic bag and seal
•
freeze each set of blood specimens immediately after processing
(within 2 hours of collection) in a -20ºC freezer (acceptable) or 70ºC freezer (preferable)
•
see Section 4.3, The Blood Log Form CRF1A for use of the “blood
log” label
•
after the contents of all of the blood collection tubes have been
aliquoted, discard the collection tubes, polystyrene centrifuge tube
and disposable plastic pipettes in the infectious waste bin
4.2 Processing the Specimens Collected at 6, 24 and 72
hours After Randomization
4.2.1 Processing the 5 mL RED top tube
15
•
after filling the tubes, let the tubes stand at room temperature until a
clot has formed in the RED top tube (approximately 30 minutes)
•
centrifuge the tube at 1500 g (3000 rpm) with the LAVENDER and
BLUE collection tubes for 15 minutes until the serum and the cells
are well separated
•
label 2 transfer vials lengthwise with the appropriate barcode labels
indicating “serum (red)”
•
ensure the barcode number matches the label on the RED
collection tube
OASIS-5
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll llllllllllllllllllllllllllllllllllllllllllll
3300001
3300001
serum (red)
serum (red)
•
transfer 1.5 to 2.0 mL of serum into each of the 2 labelled transfer
vials labelled “serum (red)”
4.2.2 Processing the 4 mL LAVENDER top tube
•
Centrifuge the LAVENDER tube with the two other collection tubes
at 1500 g (3000 rpm) for 15 minutes
•
Apply the barcode label indicating “plasma (lavender)” lengthwise
to two of the transfer vials
OASIS-5
llllllllllllllllllllllllllllllllllllllllllll
3300001
plasma (lavender)
•
ensure the barcode number matches the label on the LAVENDER
collection tubes
Please Note: All barcode labels must be applied along the long axis
of each transfer vial
•
transfer 1.5 to 2.0 mL of plasma from each of the collection tubes
into each of the two transfer vials labelled “plasma (lavender)”
4.2.3 Processing the 2.7 mL BLUE top tubes
•
centrifuge the tubes at 1500 g (3000 rpm) with the other collection
tubes for 15 minutes until the plasma and the cells are well
separated
•
label the 5 mL centrifuge tube with the label provided indicating
“plasma (blue) respin”
OASIS-5
llllllllllllllllllllllllllllllllllllllllll
3300001
plasma(blue)respin
16
•
label 2 transfer vials lengthwise with the barcode labels indicating
“plasma (blue)” and “plasma (blue) spun2x”
OASIS-5
lllllllllllllllllllllllllllllllllllll
3300001
plasma(blue)
17
OASIS-5
lllllllllllllllllllllllllllllllllllll
3300001
plasma(blue)spun2x
•
ensure the barcode number matches the label on the BLUE
collection tubes
•
transfer the plasma from one of the 2.7 mL BLUE tubes into the 5
mL centrifuge tube labelled “plasma (blue) respin”; recap the tube
•
centrifuge the polystyrene tube at 1500 g (3000 rpm) for 15 minutes
•
while the plasma from the first tube is being spun again, transfer
1.5 to 2.0 mL of plasma from the second BLUE tube into the
transfer vial labelled “plasma (blue)”
•
once the 5 mL centrifuge tube has finished the second
centrifugation, carefully remove the plasma with a new pipette,
leaving a small volume in the bottom of the tube; transfer the
plasma in the pipette to the transfer vial labelled “plasma (blue)
spun2x”
•
return the 4 labelled blood specimen aliquots to the resealable
Blood Specimen Collection Kit bag
•
the absorbent strip (small piece of white cotton cloth) must remain
in the bag to absorb moisture
•
eliminate the air from the plastic bag and seal
•
freeze each set of blood specimens immediately after processing
(within 2 hours of collection) in a -20ºC freezer (acceptable) or 70ºC freezer (preferable)
•
see Section 4.3, The Blood Log Form CRF1A for use of the “blood
log” label
•
after the contents of all of the blood collection tubes have been
aliquoted, discard the collection tubes, 5 mL polystyrene centrifuge
tube and disposable plastic pipettes in the infectious waste bin
4.3 The Blood Log Form CRF1A and Freezer Instruction
Sheet
•
the Central Laboratory Blood Log Form is a permane nt record of
the collection and shipment of Baseline and Post-Randomization
OASIS-5 specimens for central laboratory analysis and confirms
the link between the barcode number on the central laboratory
specimens and the OASIS -5 subject ID number; a sample is
provided in Appendix A
•
Baseline and the 6 hour, 24 hour and 72 hour Post-Randomization
specimens are entered on the same Blood Log Form
•
post the CRF 1A Freezer Instruction Sheet on the freezer where
you will be freezing and storing the OASIS -5 specimens; place the
CRF1A Blood Log Forms in a file near the freezer
•
enter your centre number in the upper left field at the top of Blood
Log Form CRF 1A
•
confirm the “patient ID” is printed on the line on the “blood log” label
•
ensure the barcode number matches the labels on the transfer vials
•
as each set of specimens is placed in the freezer, place the
completed “blood log” barcode label for each subject on the space
indicated on Blood Log Form CRF 1A
•
confirm the barcode number printed on the bottom of the label by
copying this number in the space provided for “Blood Label No.”
using a black ballpoint pen
•
print the patient ID number in the adjacent field on Blood Log CRF
1A using a black ballpoint pen
OASIS-5
__________________
patient ID
3300001
blood log
•
18
the Blood Log Form is to be completed for the first Baseline
specimen from the first subject, and then filed near the freezer
where the specimens are stored
•
the laboratory is responsible for storage of the Blood Log sheets for
the duration of the study; at the time of shipment of frozen samples,
the personnel preparing the shipment will fax copies of the Blood
Log sheets for the specimens in the shipment to the Project Office
at 1-905-527-5276 or to the toll-free DataFax number for your
location.
•
the frozen aliquots must be shipped on dry ice to the Central
Laboratory or National Storage Site
5.0 Handling and Storage of Central Laboratory
Specimens
•
do NOT store blood specimens in a frost-free refrigerator-top
freezer--results will be affected by temperature variation during the
freezer cycle
•
store in a freezer with minimum -20°C or preferably -70°C—if you
do not have a freezer, seek permission to use a freezer for
temporary storage in the hospital laboratory or in a research study
freezer
•
the specimens contain compounds which are sensitive to
temperature change; take all precautions to ensure the specimens
remain frozen at the study site
6.0 Preparing Blood Specimens for Shipment
Important:
Blood specimens must be shipped on dry ice on a Monday or
Tuesday only in the wax boxes which arrived at study sites filled with
collection kits. Shipments are not to be initiated between Wednesday
and Sunday as it is not possible to ensure specimens will remain
frozen over weekends.
19
•
Specimens are to be shipped to the Central Laboratory in Canada
(North American Sites only) or to the National Storage Site
•
Many of the compounds to be measured are sensitive to temperature
change; ensure specimens remain frozen during shipment preparation
and that adequate dry ice is added to the shipping box to keep
specimens frozen during the shipment.
6.1 Packing and Shipping Material Required
•
•
•
•
Specimen Collection Kit Bags containing frozen specimens
Dry Ice Box with styrofoam liner
8 to 10 Kg (or 16 to 20 lb.) of dry ice
Pad of 25 Notice of Shipment Forms (ShipForm1) for shipments
direct to Central Lab
Dry Ice must be obtained locally.
Ensure the Dry Ice Box is as full as possible to ensure sufficient dry
ice to keep the specimens solidly frozen until they arrive at the
National Site or Central Laboratory.
Do not put dry ice inside the plastic resealable bags.
6.2
Packing Dry Ice Boxes With Blood Specimens
Please follow the packaging instructions written below in order to
conform to IATA Packaging Instruction 650 for shipment of noninfectious human specimens. Samples from participants known to be
infectious (Hepatitis B virus, HIV-I and HIV-II non-cultured) are not to
be shipped.
NOTE: The transport containers meet 1B Transportation regulations.
Each Dry Ice Box is i ntended to hold 20 - 25 Specimen Collection Kit Bags
containing baseline and/or post randomization blood specimens.
•
•
•
•
Place half of the dry ice in the bottom of the shipping box
Place the Specimen Collection Kit Bags (containing blood
specimens in transfer vials, filter paper and absorbent) on top of
the dry ice
Cover and surround the specimens with the remaining dry ice
Place the lid on the styrofoam portion of the shipper
Meticulous attention to labelling will ensure delivery of dry ice
shipments:
6.2.1 Sites Outside North America shipping to Local National Storage
Site:
• Close the flaps of the box to cover the flap with the Central Lab
address and display a blank flap.
20
•
•
Prepare and affix a return address label to the blank flap.
Include your study name, site number, and the name and phone
number of a key contact at your site.
Prepare and affix an address label for shipment to your National
Site. Include name and telephone # of the person who is to
receive the shipment.
6.2.2 North American Sites shipping to Central Lab, Canada:
• Close the box so the flap with the Central Laboratory address is
visible.
• Complete your return address on the upper left corner of the
Central Lab address label
• “Enter Shipper Information”, by giving the name of a key contact
who knows about the shipment, the site address, phone number
of the contact person, and the name “OASIS -5” beside “Study
Name” (see example in Appendix A).
• Enter the unique 5-digit shipment # assigned to this shipment,
found in the top, right corner of the Notice of Shipment form
(ShipForm1).
6.2.3 All Sites:
• Tighten the belt to secure the box; DO NOT TAPE BOX SHUT.
• Ensure the Hazardous Goods label for Dry Ice is affixed to the
box (diamond with upper half stripped and ‘9’ at bottom). If the
label is not affixed to the box, please contact the CCC Project
Office.
• Record the amount of dry ice (in Kg or pounds) added to the
box on the small label with a black marker.
• Prepare shipment documentation.
7.0 Completion of Shipment Documentation
See Appendix A for samples of forms
7.1 Study Sites Outside North America Shipping to National
Storage Site
7.1.1. Commercial Invoice (CI) – Not required for shipments
within country borders.
7.1.2. Air Waybill (AWB)
•
•
21
Ask your courier for a version of the Air Waybill that allows you
to indicate the shipment is packed with dry ice.
Ship From Section: Enter name and address of person
responsible for shipment.
•
•
•
•
•
•
•
Ship To Section: Enter the name and address of your National
Storage Site.
Indicate the # of boxes shipped, and their total weight. A box of
blood specimens packed with dry ice will weigh 8 – 10 Kg
Indicate dry ice is used to pack the shipment if shipping blood
specimens.
Indicate shipment does not contain dangerous goods.
Select ‘Overnight Service’, or other appropriate service assuring
delivery within 24 – 48 hours.
Sign and date.
Tear off “Senders Copy” for retention.
7.1.3. Notice of Shipment From Study Site to National Storage
Site
•
•
The Project Office recommends that all shipments of frozen
specimens be tracked to ensure timely delivery.
A sample Notice of Specimen Shipment Form to National Site is
shown in Appendix A. Please copy and use the sample form, or
use it as a base to design a country-specific form to be used for
every shipment to the National Storage Site.
7.2 North American Sites
7.2.1. Commercial Invoice (CI) – To be completed by USA Sites -not required for Canadian Sites.
•
•
•
•
•
•
•
•
•
22
Preparation of a commercial invoice by USA sites is mandatory
to ensure shipment is accepted by courier, and will be cleared
by Canadian Customs. Incomplete documentation can delay
the shipment and result in thawed specimens. An electronic
version of the sample shown in Appendix A is available by
contacting the Project Office (rose@phri.ca).
Please ensure that all information sections shown on the
sample are included.
Date of Exportation: Actual date of shipment
Export References #: This should be a number meaningful to
your site; i.e. “OASIS -5yymmdd”
International Air Waybill (AWB) No: Enter courier AWB# here.
Importer: Leave this section blank.
# of packages: Sample indicates 1 box. Please adjust type of
packages, quantity, weight and total value to describe your
shipment.
The name and title of the shipper are to be clearly typed below
the shipper’s signature.
Date: Enter date CI signed by shipper.
• Make 2 copies of CI.
7.2.2 Air Waybill (AWB)
Please use an Expanded Service Air Waybill. This version allows
you to indicate that the shipment uses dry ice. USA sites are
provided with the International version; Canadian sites are provided
with the Intra-Canada version.
•
•
•
•
•
•
•
•
•
A FedEx AWB preprinted with the Central Laboratory address
and Project Office account number, and a clear, resealable
plastic courier envelope are included with every Dry Ice Box of
Specimen Collection Kits. Please keep the AWB and envelope
with the box until required for shipment.
Section 1: Enter name and address of person responsible for
shipment.
Section 2: If you are not using a preprinted form, please ensure
that Internal Reference is completed as “OASIS -5BL”.
Section 4: Indicate the # of boxes shipped, and their total
weight. A box of blood specimens packed with dry ice will
weigh 8 – 10 Kg. Select FedEx Priority Overnight Service.
Section 6: Indicate “Other” packaging.
Section 7: Indicate “No” to “Does this shipment contain
dangerous goods”. Check box to indicate dry ice is used. 8-10
Kg of dry ice is required for each box shipped.
USA shipments only: Country of manufacture is USA. Value for
Customs is the value calculated on the Commercial Invoice.
Carriage value is $0.
Section 10: Sign and date.
Tear off “Senders Copy” for retention
7.2.3 Notice of Shipment From Study Site to Central Laboratory
•
•
•
•
•
23
A pad of Notice of Shipment Forms (ShipForm1) is included with
the initial shipment to your site, to be used by a study site or
national storage site for the shipment of diagnostic specimens to
the Central Lab in Canada for any Population Health
Research Institute study.
Each page is prenumbered with a unique Shipment No. Please
use each Shipment No. one time only – do not photocopy blank
forms for use.
Complete the sections requiring study name, country and
detailed shipper information. Enter your study site #.
Complete courier details to allow the Project Office to track all
temperature sensitive incoming shipments.
Use the comments section to indicate any concerns or special
information about the shipment.
•
•
Enter the number of pieces for each type of package you are
shipping. OASIS -5 sites will usually ship 1 Dry Ice Box. Enter
total # of packages shipped.
Fax toll-free to 1-800 268-2370
7.3 National Specimen Storage Sites Outside North America
National Storage Sites will ship specimens received from study sites to the
Central Lab every six months. Blood specimens in cryovials will be shipped with
PHRI-provided vapor shippers, and filter papers will be shipped with ice packs in
the Dry Ice Boxes. A supplementary manual detailing shipment procedures and
the use of vapour shippers will be sent to each National Storage Site.
8.0 Finalization of Shipment & Shipment Forms
•
•
•
•
•
Affix the clear, resealable plastic courier envelope to the side of the
Dry Ice Box. For shipments to National Storage Sites, please ask your
local courier for a supply of these plastic courier envelopes.
Insert the original a nd 1 copy of the Commercial Invoice (US Sites
only) into the plastic courier envelope. Retain the 2 nd copy of the
Commercial Invoice in study files.
Insert the Air Waybill into the plastic courier envelope. Retain the
“Sender’s Copy” in a folder for OASIS -5 shipments.
Contact your local courier to advise shipment is ready for pick-up.
Fax Notice of Shipment Form
The Project Office will monitor every shipment to ensure it is
received at the Central Lab in good order, and report to the site only
in the event that the shipment is delayed or damaged.
9.0 Fax the Blood Log Form(s) at the Time of
Shipment
•
At the time of shipment, the laboratory must fax the competed Blood
Log Forms (CRF1A) for the specimens in the shipment:
1. to the Project Office at 1-905-527-5276 or the local toll-free
number for your site, and
2. The study nurse or local coordinator
•
•
24
Place the OASIS -5 Laboratory Specimen Shipment Fax Form, Blood
Log Forms (CRF1A), copy of the Commercial Invoice and Air Waybill
in the folder with the rest of the forms for the study.
Please contact Rose Mayhew at the Project Office with questions about preparation
of specimens for shipment. rose@phri.ca
Appendix A
For use by Packer:
OASIS-5
Request for Lab Supplies
Date request received: ___/___/___
Please fax to Craig Horsman at (905) 577 1403
Date order delivered: ___/___/___
Date packed: ___/___/___
Shipment #: _____ # Boxes: ____
Centre #: ________City/Country: __________________________________
Date:__/____/____
Contact Name: _____________________________
Please send the following supplies to the Centre:
______ Wax Box(es) of Baseline Specimen Collection Kits containing _____ kits per
box
______ Wax Box(es) of Post-Randomization Specimen Collection Kits containing _____
kits per box
______ Bulk Supply Kit(s)
Other Supplies (please list and give quantity to ship)/Special Instructions:
25
Notice of Shipment - ALL PHRI STUDIES
DataFax #035
SHIPFORM1
Plate #001
Visit #001
Sample for Information Only.
Please do not copy and use this form.
.
.
Shipment No.
X X X X X
Complete this form for every shipment of PHRI study
diagnostic specimens to the Central Laboratory, Canada
Fax to 1-905-527-5276 or to the PHRI toll-free DataFax number for
your location
Study Name:
Country:
Shipper Information
Check if shipper is National Storage Site
Contact person name:
Enter study site # if shipper is
not National Storage Site
Telephone:
Email:
Date shipped to PHRI:
20
Year
Month
Day
Courier Name or Method of Shipment:
Air Waybill No.:
List any concerns or comments here:
To be completed by shipper
# of pieces
Central Lab (HRLMP) Use Only
Type of package
Total Packages Received
Vapour Shipper
Dry Ice Box
Ice Pack Box
Ambient Box
Other- Please describe
Total Packages Shipped
Date received:
20
Year
Received by:
Data entry
completed for
all pieces:
Finalized by:
Month
Day
(Last name, Initial)
20
Year
Month
(Last name, Initial)
Exception Report
Day
OASIS-5
NOTICE OF SHIPMENT
From Study Site to National Storage Site
Country
________________________________
Date of Shipment: ________________________________
Site:
________
Key Contact Name: _____________________________________________
Tel:
Email:
Fax: _______________________
_____________________________________________
Courier:____________________ Air Waybill # _________________________
# Waxed Boxes_____
# cryovials
_____
Please pack specimens with dry ice.
Do you have any special concerns or information regarding the samples in this shipment? Please
specify:
Please COMPLETE AND FAX to your National Storage Site for every shipment.
Thank you
1
OASIS-5
PROCESSING OF BASELINE BLOOD SAMPLES
10 mL Red Top Tube
2 Lavender Top Tubes
2 Blue Top Tubes
Allow clot
Formation
(~30 min.)
CENTRIFUGE ALL FIVE TUBES AT 3000 rpm (1500 g) FOR 15 MINUTES (WITHIN 2 HOURS OF TIME OF BLOOD COLLECTION)
LABEL TRANSFER VIALS and CENTRIFUGE TUBE WITH APPROPRIATE BAR-CODED LABELS
Transfer 1.5 mL of serum
into 3 transfer vials labeled
with RED barcode labels
Transfe r 1.5 mL of plasma into
2 transfer vials labeled with
LAVENDER barcode labels
Transfer 1.5 mL of plasma
from one blue top tube into
transfer vial labeled with
BLUE barcode label
Transfer thin layer of white cells
from each tube into one of the two
transfer vials labeled with BUFFY
COAT barcode labels
Transfer 1.5 mL of
plasma from second blue
top tube into 5 mL
polystyrene centrifuge
tube labeled with
“respin” barcode label
CENTRIFUGE TUBE AT 3000 rpm
(1500 g) FOR 15 MINUTES
Transfer 1.5 mL of plasma into
transfer vial labeled
plasma(BLUE)spun2x”
PLACE 9 CYROVIALS INTO RESEALABLE PLASTIC KIT BAG PROVIDED.
FREEZE WITHIN 2 HOURS OF COLLECTION AT -70ºC (PREFERRED) OR -20ºC (ACCEPTABLE).
2
OASIS-5
PROCESSING OF POST-RANDOMIZATION BLOOD SAMPLES
5 mL Red Top Tube
Lavender Top Tube
2 Blue Top Tubes
Allow clot
Formation
(~30 min.)
CENTRIFUGE ALL FOUR TUBES AT 3000 rpm (1500 g) FOR 15 MINUTES (WITHIN 2 HOURS OF TIME OF BLOOD COLLECTION)
LABEL TRANSFER VIALS and CENTRIFUGE TUBE WITH APPROPRIATE BAR-CODED LABELS
Transfer 1.5 mL of serum
into 2 transfer vials labeled
with RED barcode labels
Transfer plasma evenly into
2 transfer vials labeled with
LAVENDER barcode labels
Transfer 1.5 mL of plasma Transfer 1.5 mL of
from one blue top tube into plasma from second
transfer vial labeled with
blue top tube into 5mL
BLUE barcode label
polystyrene centrifuge
tube labeled with
“respin” barcode label
CENTRIFUGE TUBE AT 3000 rpm
(1500 g) FOR 15 MINUTES
Transfer 1.5 mL of plasma
into transfer vial labeled
plasma(BLUE)spun2x”
PLACE 6 CYROVIALS INTO RESEALABLE PLASTIC KIT BAG PROVIDED.
3
FREEZE WITHIN 2 HOURS OF COLLECTION AT -70ºC (PREFERRED) OR -20ºC (ACCEPTABLE).
MICHELANGELO:
OASIS 5
DataFax #145
BLOOD LOG
CRF 1A
Plate #001
Visit #001
SAMPLE ONLY
Center #
Page
Number:
Patient I.D. Number
Place Blood Log
Sticker Here
Barcode No.
Patient I.D. Number
Place Blood Log
Sticker Here
Patient I.D. Number
Place Blood Log
Sticker Here
Barcode No.
Patient I.D. Number
Place Blood Log
Sticker Here
Patient I.D. Number
Place Blood Log
Sticker Here
Barcode No.
Barcode No.
Place Blood Log
Sticker Here
Barcode No.
Place Blood Log
Sticker Here
Barcode No.
Barcode No.
Patient I.D. Number
Place Blood Log
Sticker Here
Patient I.D. Number
Place Blood Log
Sticker Here
Barcode No.
Patient I.D. Number
Patient I.D. Number
Place Blood Log
Sticker Here
Barcode No.
Patient I.D. Number
Patient I.D. Number
Place Blood Log
Sticker Here
Barcode No.
Barcode No.
Patient I.D. Number
Place Blood Log
Sticker Here
Barcode No.
NOTE: Please keep Blood Log CRF 1A on file at local laboratory
Waybill#
Shipper’s Name:
(Please Print)
Date Samples Shipped From Site
Year
Month
Day
Version 1.0
OASIS-5
Blood Log Form CRF1A
Freezer Instruction Sheet
Please post this Instruction sheet on the freezer
where OASIS-5 samples will be stored.
• enter your centre number in the upper left “Centre #” field on
each Blood Log Form CRF1A
• number each Blood Log Form CRF1A sequentially in the upper
right field indicating “Page Number”, starting with “001”
• as each set of samples arrives, pull the OASIS-5 “blood log” label
from the specimen bag and ensure “patient ID” has been entered on
the line above the barcode number; if it is missing, contact the study
nurse or coordinator at your site
• ensure the barcode number on the label matches the barcode
number on the blood samples in the bag
• enter Baseline, 6 hour, 24 hour, and 72 hour specimens on the
same Blood Log sheet CRF1A
• place the “blood log” label for each subject on the space indicated
on Blood Log CRF1A
• confirm the barcode number printed on the bottom of the label by
printing this number in the space provided for “Blood Label No.” using
a black ballpoint pen
• print the patient ID number in the adjacent field on Blood Log
CRF1A using a black ballpoint pen
• AT TIME OF SHIPMENT : complete the bottom of the form with the
Courier Company, Air Waybill #, and date of shipment from the study
site. Enter shippers name, and fax to the Blood Log CRF1A form(s)
with stickers to 1-905-527-5276 or to the toll-free DataFax number for
your location at the time of shipment.
5