Transcript Study Drug - Stripes

Investigators: Kusum Menon, Dayre McNally, Katie O’Hearn,
Margaret Lawson, Karen Choong, Lauralyn McIntyre, Hector Wong.
STUDY COORDINATING CENTRE (SCC)
 Children’s Hospital of Eastern Ontario Clinical
Research Unit (CHEO CRU)
 Support from the Methods Centre at the Ottawa
Hospital Research Institute (OHRI)
 Data management
 Randomization system
CO-INVESTIGATORS & STEERING COMMITTEE
 Anand Acharya
 Karen Choong (Steering Committee member)
 Lynda Khalaf
 Margaret Lawson (Steering Committee member)
 Lauralyn McIntyre (Steering Committee member)
 Dayre McNally (Steering Committee member)
 Timothy Ramsay (Steering Committee member)
 Hector Wong (Steering Committee member)
ER/ICU physicians, Site Research Coordinators & Site Investigators
will have 24/7 pager support from a member of the Steering
Committee for clinical queries and concerns
REGULATIONS
 Phase IV study
 Must adhere to GCP, TCPS and Health Canada Food and
Drug Regulations with the following exceptions
 C.05.006 Authorization: A CTA from Health Canada is not required for
Phase IV studies
 C.05010 (i) Good Manufacturing Practises: do not apply (responsibility
of the manufacturer)
 C.05.012 (e) Records regarding shipment, receipt, disposition, return
and destruction of drug: Only Phase I to III studies where a marketed
drug is being used outside it’s approved indications, must do drug
accountability
 C.05.011 Labelling: It is acceptable for the marketed drug to be labelled
in accordance with its marketing authorization provided that the
labelling on the marketed drug is appropriate for the trial. The label
information should not compromise the blinding and the expiration
date needs to be identifiable.
TODAY
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Recruitment, Enrolment & Consent
Randomization
ICU Procedures
Pharmacy Procedures
BREAK
Lab Procedures
eCRF and Data Collection
DMSC
Monitoring
Administrative Information, Other
QUESTIONS?
Investigators: Kusum Menon, Dayre McNally, Katie O’Hearn,
Margaret Lawson, Karen Choong, Lauralyn McIntyre, Hector Wong.
OVERVIEW
Exclusion criteria present.
Patient not eligible.
Patient aged newborn to 17 years with shock is
started on any vasoactive agent in the PICU or
the Emergency Room → Care team notifies study
staff
Study staff will verify inclusion and exclusion criteria
Patient is eligible
Enrolled using Deferred Consent OR Informed
Consent obtained
Patient must be randomized
within 6 hours of being started
on a vasoactive agent
Patient must receive first dose
of study drug within 8 hours
Randomize
Blood
sample
INTRAVENOUS
INTRAVENOUS NORMAL
HYDROCORTISONE
SALINE PLACEBO
IDENTIFICATION OF PARTICIPANTS
 Where: Identified in the PICU or the Emergency Room
 Who: ER/PICU nurses, physicians, trainees
 When: At the time any vasoactive agent(s) of any dose is
started for the treatment of shock
ELIGIBILITY CRITERIA - INCLUSION
Inclusion Criteria
1. Children newborn to 17 years; and
2. On any dose of any vasoactive infusion for at least one
hour but ≤ 6 hours.
ELIGIBILITY CRITERIA - EXCLUSION
Exclusion Criteria
1.
2.
3.
4.
5.
6.
7.
8.
Known or suspected HPA axis disease;
Received more than one dose of systemic steroids in the last 10
days or any dose of systemic steroids in the last 24 hours;
Expected to have treatment withdrawn;
Premature infants (<38 weeks corrected GA);
Pregnant;
Post cardiac surgery;
First dose of vasoactive infusion received >24 hours after PICU
admission
Patient no longer on vasoactive infusion at time of enrollment
and/or expected to no longer be on vasoactive infusion at the
time first study drug dose would be administered
Exclusion Criteria con’t
9. Primary cardiogenic shock is strongly suspected (e.g.
clinical signs of heart failure, large heart on chest
radiograph etc.);
10. Spinal shock is strongly suspected (e.g. history and physical
findings compatible with spinal injury and/or mass); and
11. Hemorrhagic or hypovolemic shock is strongly suspected
(e.g. history suspicious of blood or fluid loss).
**Criteria #9 to 11 are based on the clinical judgment of the
treating physician. **
Consult with MRP to verify exclusion criteria #9 to 11
SCREENING LOG
 Any patient who is started on a vasoactive infusion within
the first 24 hours of PICU admission should be screened
for eligibility and included on the study screening log
 Screening log faxed to Study Coordinating Centre (SCC)
first Monday of every month
PRISM III score: if collected by your
site can enter just the score.
Otherwise you will need to complete
the PRISM III worksheet for eligible,
non-randomized patients
INCLUSION & EXCLUSION CHECKLIST
 Paper inclusion and exclusion checklist completed during
screening and filed in study binder
 Inclusion and exclusion criteria will also be entered into
the randomization system and recorded in the electronic
case report form (eCRF)
CONSENT PROCESS
DEFERRED CONSENT
 Approved by CHEO REB
 Use of MICYRN REB to facilitate approval at other sites
 If deferred consent is not approved at your centre, follow
normal informed consent process
DEFERRED CONSENT PROCESS
1. Patient eligibility confirmed
2. Study staff obtaining consent determines if legal guardian is
present
3. If present, study staff determines if (1) MRP has already spoken
to legal guardian about child’s medical condition AND (2) there
is adequate time to conduct true informed consent
o If “YES” to # 1 and #2  use informed consent model
o If “NO” to #1 and/or #2 OR if legal guardian is not present
 use deferred consent model (document in consent note)
4. Patient enrolled and randomized
5. Poster hung at patient’s bedside to state patient has been
enrolled in STRIPES study
6. Deferred consent pamphlet given to health care team. Health
care team to give pamphlet to family as soon as is appropriate.
DEFERRED CONSENT PROCESS
7. Study staff works with MRP and circle of care to determine an
appropriate time to speak with legal guardian (all attempts to
obtain consent, including asking circle of care if time is
appropriate, must be documented in a note to file)
8. Before approaching legal guardian, member of circle of care asks
legal guardian if study staff can speak to them
9. Study staff approaches legal guardian for informed consent
o Informed consent obtained  continue with study
procedures
o Informed consent refused  study drug stopped, study staff
to ask legal guardian if data collection can continue and/or if
any collected blood can still be analyzed
Bedside Poster
DEFERRED CONSENT
What if a patient enrolled using deferred consent dies
before informed consent is obtained?
MRP will notify the legal guardian of child’s enrollment into the
STRIPES study and ask if Site Investigator can speak to them.
If legal guardian says “Yes”
• Site Investigator will fully inform legal guardian of all aspects
of the study. Legal guardian will decide what to do with any
data collected about their child prior to death.
DEFERRED CONSENT
What if a patient enrolled using deferred consent dies
before informed consent is obtained?
If legal guardian says “No”
• Data that has been collected will be retained, all further data
collection will stop.
If legal guardian says “No, we do not believe in research”
• Data that has been collected will be destroyed.
ENROLMENT TIME LINE
Time Zero is
when patient is
started on first
dose of any
vasoactive agent
Vasoactive
Infusion
started
TIME 0
Regardless of consent model used
(deferred or informed) randomization
must occur between 1 to 6 hours
following the first dose of the vasoactive
infusion
Window for Enrolment and Randomization
1 HR
2 HR
3 HR
4 HR
5 HR
First dose of study drug
must be administered
within the 8 hours
following the first dose
of the vasoactive
infusion
First dose of
study drug
6 HR
< 8 HR
Once eligibility is confirmed, but before randomization,
study staff should phone the pharmacy to ensure study drug
can be dispensed within the 8 hour time frame
QUESTIONS?
Investigators: Kusum Menon, Dayre McNally, Katie O’Hearn,
Margaret Lawson, Karen Choong, Lauralyn McIntyre, Hector Wong.
RANDOMIZATION PROCESS
BEFORE RANDOMIZATION: Study staff must call pharmacy to
ensure study drug can be dispensed within the 8 hour time
frame
1. Research Coordinator/Assistant will log in to the
randomization system and enter inclusion and exclusion
criteria.
2. Research Coordinator/Assistant will receive an email with a
pharmacy ID number (ID number will also appear on screen)
3. Each site pharmacy will be given a randomization schema list.
RANDOMIZATION PROCESS
4. Research Coordinator/Assistant will indicate ID number from
randomization system on order given to pharmacy
5. Pharmacy will match the ID number to the randomization list
to determine allocated treatment
6. Research Coordinator/Assistant will print randomization
sheet and file in study binder
RANDOMIZATION WEBSITE
• Developed and hosted by the Methods Centre at the
OHRI
• https://dms.ohri.ca/Stripes
SAMPLE EMAIL
Participant Randomization Number
to be included on order given to
pharmacy
Pharmacy will use this number to
determine treatment allocation
WHAT IF THE RANDOMIZATION SYSTEM IS
NOT WORKING?
 Bring the order form to pharmacy, and inform pharmacy staff
 Pharmacy staff will assign patient the next sequential number
on the site randomization list and allocate treatment
 Study staff: ensure you get the ID assigned from pharmacy for
use on study documents and eCRF
 Notify the Methods Centre at [email protected] as soon as possible
after enrolling patient and inform them of the randomization
number that was used
 Web-based system will be adjusted so the manually assigned
number will not be re-assigned later
QUESTIONS?
Select the red “+” sign to randomize
a new participant
Complete the inclusion and
exclusion criteria, then select
“Proceed to Randomize this
Participant”
Randomization #
appears here and in
email
Print and file in site
regulatory binder
Investigators: Kusum Menon, Dayre McNally, Katie O’Hearn,
Margaret Lawson, Karen Choong, Lauralyn McIntyre, Hector
Wong.
ICU PROCEDURES: STUDY DRUG
*Escalation of Therapy defined as an
increase in vasoactive infusion(s) OR any
fluid bolus(es) including saline, ringer’s
lactate, albumin or blood products for low
blood pressure, elevated heart rate or
signs of poor perfusion
Bolus Dose: 2mg/kg
1 mg/kg q6h until there has been no
escalation of therapy* for at least 12 hours
If following the initial study drug wean, the
patient requires fluid boluses and/or an
increase in vasoactive infusion(s), study
drug should be increased back to
1 mg/kg q6h until they meet stability
criteria again (i.e. no escalation in therapy
for at least 12 hours)
No escalation in therapy should be
determined together with the resident, fellow
or staff physician twice daily during morning
and evening rounds
1 mg/kg q8h until the patient is off all
vasoactive agents for 12 hours
Study drug should be continued for a
maximum of 7 days/168 hours
No wean necessary
ICU PROCEDURES: BLOOD SAMPLE
• A single blood sample will be collected for analysis of free and
total cortisol, vitamin D metabolites, and stratification
biomarkers
• 3 mL of blood in red top tube (supplies will be provided by the
SCC)
• Drawn through existing lines or with clinically-indicated
bloodwork (no needle poke solely for research test)
• Drawn following randomization but prior to initiation of study
drug
o If access not available prior to study drug, but becomes
available within first 24 hours, sample should still be
drawn
o If < 3 ml can be obtained, sample should still be drawn
ICU PROCEDURES: BLOOD SAMPLE
• The person who draws the blood sample will need to
complete the requisition to indicate how the site laboratory
should separate the sample
• If drawn before study drug: all cryovials should be checked off
on form
• If drawn after initiation of study drug, only blue and pink
cryovials should be filled (no cortisol analysis)
REQUISITION FORM
ICU PROCEDURES: CO-INTERVENTIONS
• The requirement for co-interventions will be left to the
discretion of the treating physician.
• The Surviving Sepsis Guidelines Flowchart should be given to
the health care team for easy reference but it’s use is not
mandated.
ICU PROCEDURES: OPEN-LABEL STEROIDS
• We encourage attending physicians to avoid open-label
hydrocortisone use.
• If open-label hydrocortisone is used:
o The research assistant will speak with the treating
physician to determine the reason(s) why
o Patient will remain in the study
• Open-label hydrocortisone use is not considered a protocol
violation
ROLE OF THE ICU/ER MEDICAL TEAM
(NURSE AND PHYSICIANS)
• Notify study staff as soon as a patient with shock is started on any
vasoactive agent
• Assist study staff to determine exclusion criteria #7 to 9
• Assist study staff to identify an appropriate time to approach legal
guardian about consent, ask legal guardian permission for study
team to approach
• Administer study drug according to protocol (includes determining
stability criteria)
• Draw blood sample and complete requisition form
BEDSIDE PACKAGE
 The bedside package should include:
 Deferred consent pamphlet
 Bedside poster
 Blood sample supplies
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pre-labelled collection tube, cryovials, specimen bag, lab requisition
provided by SCC
Blood sample instruction sheet
Pre-printed order form
Surviving Sepsis flowchart
Study information sheet for PICU staff
Study procedure flowchart
Site study team contact information
All the above documents will be available on the study website
QUESTIONS?
Investigators: Kusum Menon, Dayre McNally, Katie O’Hearn,
Margaret Lawson, Karen Choong, Lauralyn McIntyre, Hector Wong.
PHARMACY PROCEDURES
 Specific pharmacy procedures will vary from site to site
depending on local pharmacy SOP
 No central pharmacy for this study, but site pharmacists can
contact the Manager of Drug Distribution at the SCC with
questions/concerns
 Contact information will be included in pharmacy SOP
ORDERING & PREPARING STUDY DRUG
 Each site pharmacy responsible for procuring and storing
the study drug for participants enrolled at their site.
 Recruitment will be capped at 24 patients per site
 Expected that each site will recruit between 6-12 patients
 Pharmacies prepare hydrocortisone and placebo
solutions for the patients enrolled at their centre
 Hydrocortisone : made up as a 10 mg/ml intravenous solution
 Placebo : normal saline solution made up in equivalent volume
TIMELINE
 First dose of the study drug must be administered within 8
hours from the time when the patient was first started on a
vasoactive agent (Time 0)
 Before entering patient information into randomization
system, study staff will contact pharmacy to ensure study drug
can be dispensed before 8 hour cut-off
 If study drug is given beyond the 8 hour window, the Site
Research Coordinator will record this as a protocol violation
and inform the SCC
RANDOMIZATION & BLINDING
 Randomization lists: only accessible to Methods Centre at
OHRI and to pharmacy staff at each site
 Should not be seen by anyone else directly involved with the
study
 Pharmacies must maintain a list of randomized patients and
treatment allocation
 Pharmacy staff should ensure that any labels used on the
study drug package do not unblind the participant
PHARMACY HOURS OF OPERATION &
ENROLMENT
 Hours during which patients can be enrolled into the study will
vary from site to site depending on the availability of the oncall research coordinator and the hours of operation of the
pharmacy.
 Prior to initiation of the study, meet with your pharmacy team
to determine during which hours study patients can be
enrolled.
 Consider 8-hour limit to dispense the study drug when
determining the time window for study enrollment.
OPTION TO ENROLL DURING PHARMACY
OFF-HOURS
• Site pharmacy prepares numbered medication kits following
the randomization list and stores them in PICU
• Stock solutions rather than patient specific volumes
•
Nurse would have to withdraw the appropriate volume
required for the bolus (2mg/kg)
• Pharmacy would take over preparing the doses once they
opened
• Kits would need to be re-made every X number of days
(depending on storage time your pharmacy uses)
QUESTIONS?
Investigators: Kusum Menon, Dayre McNally, Katie O’Hearn,
Margaret Lawson, Karen Choong, Lauralyn McIntyre, Hector Wong.
BLOOD SAMPLE SUPPLIES
 Instruction sheet for bedside nurse will be available on
the study website
 SOP for lab staff
 Lab supplies provided to each site by SCC
 Blood sample supplies (pre-labelled collection tube,
cryovials, specimen bag, research requisition)
 Pre-labelled storage boxes (1 x -80°C and 1 x -20°C box)
 TDG approved shipping supplies
BLOOD SAMPLE PROCEDURES - LAB
 Centrifuge collected blood sample
 Aliquot serum into pre-labeled 2mL cryovials according to
study requisition and according to prioritization order
 Store cryovials in -20°C or -80°C as indicated on requisition
 Samples stored at site until end of the study recruitment period
(maximum of 12 months)
Cryovials will be colour-coded to facilitate the above
SHIPMENT OF SAMPLES
 Samples shipped to SCC at end of storage period
 Notify Study Coordinator by email when the samples are
shipped.
 Include in the email a complete inventory list of the samples
being sent.
 The person shipping the samples must be trained in the
Transportation of Dangerous Goods (TDG).
 Samples must be shipped from each site on dry ice according
to the TDG Regulations for a Class 6.2 and 9.0, Category B
specimen
 Packed according to the appropriate International Air
Transport Association (IATA) packing instructions
CENTRAL LAB
Eastern Ontario Regional Laboratory Association (EORLA)
laboratory at the Ottawa Hospital TOH will act as the central
lab
Central Lab Contact Information:
Carol Ann Jodouin, Manager, Clinical Research
Operations
EORLA/ALERO Site: The Ottawa Hospital, General Campus
501 Smyth Road, Ottawa, Ontario
K1H 8L6
Phone: 613-737-8899 ext. 79010 or ext. 16038
Email: [email protected]
QUESTIONS?
Investigators: Kusum Menon, Dayre McNally, Katie O’Hearn,
Margaret Lawson, Karen Choong, Lauralyn McIntyre, Hector Wong.
REDCAP
 REDCap (CHEO RI instance)
 Data stored on secure servers at CHEO CRU
 Unique user ID and password
 Notify study coordinator who will need access
from your site
 Each site will only see data from their own site
REDCAP BASICS
The following instructions will also be included in the eCRF
SOP
https://redcap.cheori.org/
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
How to access project
Staring a new record
Editing a record
Saving data form
Form status
Validation of entry fields
ECRF SECTIONS
 1. Patient Eligibility Criteria & Enrolment
Information
 2. General Demographic Baseline
Information
 3. PICU Admission PRISM III
 4. PELOD-2 Organ Dysfunction Score on
Admission and Daily Until Off of Vasoactive
Agents
 5. Duration of Vasoactive Infusions
Administered During PICU Admission
 6. Daily Administration of Vasoactive Agents
During PICU Admission
 7. Fluid Bolus and Intake/Output
 8. Mechanical Ventilation
 9. Acute CPAP or BiPAP Ventilation
 10. Research Blood Sampling & Adrenal
Testing
 11. Use of Ranitidine, Pantoprazole or
Lanzoprazole
 12. Red Blood Cell Transfusions and
Hemoglobin
 13. Gastrointestinal Bleeding
 14. Daily Insulin Infusion
 15. Lab Results
 16. Cultures & Antibiotics
 17. Outcome Information
 18. Study Drug
 19. Unblinding and Open-Label Steroid Use
 20. Economic Variables
 21. Protocol Deviation/Violation Reports
 22. Serious Adverse Event Reports
 23. Co-Enrolment
 24. Case Report Sign Off
 25. Research Blood Sample Results & Group
Assignment **THIS SECTION WILL BE
COMPLETED BY THE SCC**
DATA COLLECTION TIMELINE
 Data can be collected on a daily basis or at the end of
PICU admission with the following exceptions:
1.
Economic Variables
Some of the data collected in this section may not be recorded in
the patient’s chart and will need to be collected in real time.
Examples:
 Nurse: Patient ratio
 Where caregiver is staying
 Caregiver work status
DATA QUERIES
 Data queries will be addressed using the Data Resolution
Workflow in REDCap
1.
2.
3.
4.
5.
SCC will open data query within the Data Resolution
Workflow application
SCC will notify Site Research Coordinator that a data query
has been opened
Site Research Coordinator must log into the eCRF, review
and respond to the query
Once the query has been resolved, the SCC will close the
query
REDCap system will record and document entire process
PROTOCOL VIOLATIONS/DEVIATIONS
 Protocol deviations and violations must also be documented in the eCRF
 Examples of a protocol deviation in the STRIPES study are:
 Patient is randomized but does not receive the study drug
 Patient died before receiving study drug
 Examples of a protocol violation in the STRIPES study are:
 Patient is enrolled > 6 hours after being started on a vasoactive agent
 First dose of study drug is given > 8 hours after being started on a vasoactive agent
 Enrolment of a patient not meeting inclusion criteria
 Failure to report a serious adverse event
 Study medication dispensing or dosing error
 Study drug not weaned when patient meets weaning criteria
 Patient is un-blinded
SAES TO BE REPORTED
 Screened from randomization to 28 days post-randomization
or discharge (whichever is later)
Severe gastrointestinal bleeding that requires transfusion or
surgery;
2. Gastric perforation, or
3. Death.
1.
• Since ICU patients commonly develop complications of critical
illness, related or unrelated to the reason for their admission
to the ICU (e.g. nosocomial infection, organ failure, myocardial
infarction) these often expected events in the course of
patients requiring life support will not be reported as SAEs in
the STRIPES Pilot Study
SAES TO BE REPORTED
 SAE reporting form completed in eCRF
 Notify study coordinator when a SAE report is completed at
your site
 SAE report must be signed by Site Investigator
 E-signed or printed, signed and faxed to SCC
 Time frame for sending out depends on:
 SAE severity grading
 Relationship between SAE and study participation
 Reporting time frames will be specified in the study SOP
ELECTRONIC SIGNATURE
 Site Investigators will be able to “e-sign” eCRF Sign-Off
Page and SAE reports in REDCap
 Once section is e-signed, data cannot be changed
https://redcap.cheori.org/
QUESTIONS?
REDCAP BASICS
 How to access project
1. Enter your personal login information to access the
eCRF.
2. Click on the “My Projects” tab at the top of the screen
Select “STRIPES Pilot RCT”
3. This will take you to project homepage.
REDCAP BASICS
Starting a new record or Editing a record
New participant:
Select “Add/Edit Records” from the menu on
the left-hand side of the screen
 Enter the new study ID code and press the
“Tab” or “Enter” button

Existing participant:

Choose the participant ID code from the
“Complete” or “Incomplete” drop down
menu, or

Enter their ID code and press the “Tab”
or “Enter” button, or

Select “Record Status Dashboard” and
select the appropriate section of the
eCRF.
REDCAP BASICS
Saving Data Form
 Forms do NOT save automatically
 Highly recommended to save as you go
along
 Save Record: Will save & take you back to
the project homepage.
 Save and Continue: Will save & remain on
the same section.
 Save and go to Next Form: Will save & take
you to the next section.
REDCAP BASICS
Form Status
 Gray Circle: No data has been entered
 Red Circle: Form saved as Incomplete
 Yellow Circle: Form saved as Unverified
 Green Circle: Form saved as Complete
REDCAP BASICS
Validation of entry fields
 Data entry fields validated when possible
 Range of expected values entered when possible
 Number of decimal places required validated
 Fields marked as required
REDCAP BASICS
E-Signature
 Data entry fields validated when possible
 Range of expected values entered when possible
 Number of decimal places required validated
 Fields marked as required
Investigators: Kusum Menon, Dayre McNally, Katie O’Hearn,
Margaret Lawson, Karen Choong, Lauralyn McIntyre, Hector Wong.
DMSC MEMBERS
 The Data Monitoring and Safety Committee will include:
 A senior biostatistician (Dr. Dean Fergusson, DMSC Chair)
 A pediatric endocrinologist (Dr. Alex Ahmet)
 A pediatric intensive care specialist (Dr. Ari Joffe)
DMSC TERMS OF REFERENCE
 The DMSC will review all serious adverse events and will
communicate directly with the principal investigator.
 There will be no stopping rules;
 DMSC can make recommendations to the PI who will
communicate back to the Steering Committee at the end of the
trial regarding any safety concerns for the full trial.
 The DMSC will meet every 3 months during the conduct of the
study.
 If deemed necessary, the DMSC may meet more frequently.
 Between meetings, the DMSC will receive information
concerning post-randomization serious adverse events from all
participating centers.
DMSC TERMS OF REFERENCE
 For each meeting, the Steering Committee will provide the
DMSC with tabulated information on SAEs by intervention
group and by study center (blinded as group A and B).
 After each meeting, the DMSC chair will provide the PI with a
letter stating the general outcome of the meeting and any
suggested changes to the design or conduct of the study.
 At completion of the trial, the Steering Committee will
provide the DMSC with analyses by group.
 Relative rates of gastrointestinal bleeding, infections and hospital
mortality.
 Controlled for centre and will provide both unadjusted analyses
and analyses adjusted for age and PRISM score.
QUESTIONS?
Investigators: Kusum Menon, Dayre McNally, Katie O’Hearn,
Margaret Lawson, Karen Choong, Lauralyn McIntyre, Hector Wong.
MONITORING VISITS
 A site monitoring visit may be conducted by the SCC up to
3 times during the course of the study:
 At study start up
 Mid-way through the recruitment period
 At study close out
MONITORING REPORT
 SCC will provide the site with a monitoring report within 5
business days of visit/teleconference.
 Sites responsibility to respond to any observations within
30 days.
 There should not be any unresolved issues at the following
monitoring visit.
 All monitoring correspondence should be stored in the
site regulatory binder.
QUESTIONS?
Investigators: Kusum Menon, Dayre McNally, Katie O’Hearn,
Margaret Lawson, Karen Choong, Lauralyn McIntyre, Hector Wong.
STRIPES Website
 http://stripes.ccctg.ca/
 All study documents available
 Contact information
 Links to REDCap and randomization web-site
 News and newsletters
 Will also send email when important updates/documents
are posted
 Suggestions welcome
MICYRN
 MICRYN REB application form must be submitted to your
local REB with application
 Hope is that this will facilitate approval of deferred
consent model across all sites
Contracts
 Contracts have been sent out to each site along with site
budget
 Contact Study Coordinator with any issues/concerns
Travel Receipts
 Envelope provided in folder to send travel receipts to SCC
for reimbursement
 Reimbursed according to CIHR policies
Co-Enrolment
 Age of Blood in Children in Pediatric Intensive Care Units
(ABC-PICU)
 Squeeze trial?
 Will be discussed with CCCTG group on June 17th
Regulatory Binder
 SCC will provide each site with a regulatory binder
QUESTIONS?