Ontario Cancer Research Ethics Board
MaRS Centre, Suite 510 | 661 University Avenue
Toronto, Ontario | Canada M5G 0A3
416-673-6649 or 1-866-678-6427 ext. 6649 | www.ocreb.ca
Monthly Teleconference Summary
February 5, 2016 at 9am
ATTENDEES
1. Hamilton Health Sciences
 Juravinski Cancer Centre
 McMaster Children’s Hospital
Sites: 2. Lakeridge Health (Oshawa)
3. Lawson (London)
 LRCP
4. Markham Stouffville
OCREB:
Aurora de Borja, Terry Liu, Janet Manzo, Cindy Sandel, Alison van Nie, Kathie Zeman
REGRETS
10.
11.
12.
13.
14.
Sites:
OCREB:
5. Niagara Health System
6. Royal Victoria Regional Health Centre
7. Sunnybrook Health Sciences Centre
 Odette Cancer Centre
8. Trillium Health Partners - Credit Valley Hospital
9. UHN - Princess Margaret Cancer Centre
 Clinical Trial Support Unit
Cambridge Memorial
Grand River Hospital
Health Sciences North (Sudbury)
Humber River Hospital
Kingston General Hospital
 Kingston General – Pediatrics
15. Mount Sinai Hospital
16. The Ottawa Hospital
 Cancer Centre
 Biologics
 Other (URO, HEM, OHRI)
17. North York General Hospital
18.
19.
20.
21.
22.
23.
24.
25.
SickKids (Toronto)
Southlake Regional Health Centre
St. Joseph’s Healthcare (Hamilton)
St. Joseph’s Health Centre (Toronto)
St. Michael’s Hospital
Thunder Bay Regional Health Sciences Centre
Toronto East General
Trillium Health Partners – Queensway Health
Centre
26. William Osler Health Centre
27. Windsor Regional Hospital
28. Women’s College Hospital
Richard Sugarman (Chair), Yooj Ko (VC), Mark Whissell (VC)
If you temporarily have to leave the teleconference, please hang up and dial in again when you are able to re-join.
Putting your phone on hold causes interference with all of the other lines.
NOTEWORTHY ITEMS
A place for sharing new information, updates and other noteworthy items affecting the research community…
1. French Clinical Trial Death
http://www.sciencemag.org/news/2016/02/french-company-bungled-clinical-trial-led-death-and-illness-report-says




First participant to be hospitalized (and later to die) did not cause the trial to be halted immediately;
Participants remaining in the trial were not provide with the new information about the serious adverse
event and received drug (4 experienced serious adverse events;
Biotrial's exclusion criteria (for participant enrolment) for use of psychoactive substances were inconsistent
and not precise enough, the report says;
Death of participant was not reported to the authorities until 3 days after the trial was stopped which
prevented the authorities from protecting other participants.
2. Identifying public expectations of genetic biobanks
https://www.researchgate.net/publication/290598197_Identifying_public_expectations_of_genetic_biobanks
3. Women fear genetic test for breast cancer could drive up insurance costs:
http://www.cbc.ca/beta/news/canada/montreal/women-fear-genetic-test-for-breast-cancer-could-drive-upinsurance-costs-1.3423137
Teleconference 2016-Feb-05
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4. News from Rebecca Skloot – Your Cells. Their Research. Your Permission??? (comments on the common
rule)
http://www.nytimes.com/2015/12/30/opinion/your-cells-their-research-your-permission.html
5. TCPS2 education update
http://www.pre.ethics.gc.ca/eng/resources-ressources/news-nouvelles/nr-cp/2015-12-22/
6. CCO policy update
https://www.cancercare.on.ca/cms/one.aspx?objectId=351985&contextId=1377
7. BCCRIN - Announcement of Canadian Clinical Research Participation Survey – in conjunction with N2
Canada’s Clinical Research Community Needs Public Input: If you have participated in a clinical trial, were
asked to participate and declined, or if you are the parent of a child who has been asked or has participated,
your feedback is important to the future of research in Canada. The anonymous survey can be accessed at:
www.bccrin.ca/survey
NOTICES
Name Change
NCIC-CTG changes name to CCTG
Change in O2 Support Coverage
Terry Liu’s last day with OICR/OCREB is February 19, 2016. Janet has been covering O2 Support during Terry’s
absences since Safia left last August. Given the less intense activity and minimal O2 Support requirements, the interim
plan will be for Janet, Aurora and Victoria (when she returns) to cover O2 Support. OICR IT personnel, as well as the
system vendor personnel are available to manage any technical issues and patches.
Also, the system now has a new automatic password reset feature. Users can click on the “Forgot Password?" link,
enter their UserID and institutional email address to request a new password. Once the system validates the email
address, the system will email the user with a new temporary password. If the email address is not validated, the user
will have to send a password reset request to O2 Support.
O2 Training
Hands-on new user, refresher training and advanced training sessions can be made available via webcast for
provincial or centre applications. On-site training (i.e., at the centre) can be arranged if there are enough attendees.
For those in the GTA, training at the OCREB office also can be arranged. The next training sessions are scheduled for
February 9 @ 1pm. Please contact Kathie Zeman or Aurora de Borja to arrange O2 training.
REMINDERS
Signature Page with Date Formatting
Please note the date formatting has been removed from the current ICF templates – for older template please ensure
that dates are recorded as per the format which occurs below the data line. Removal of the date formatting should be
noted at the time of the next ICF amendment.
Close out activities prior to submission of the provincial study closure
Please note that OCREB requirements for the provincial study closure indicate that all participating centres must be
closed prior to the provincial study closure. Centre study closure reports are submitted when there is no further
participant involvement at the centre; all new data collection is complete; and the sponsor closeout activities have been
completed.
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Granting O2 Access to Sponsors and CROs
O2 Support will provide sponsor/CRO reps with O2 accounts upon request. Since they require copies of the REB
materials, please consider granting them access to the study materials in O2. To do so, the PA would use the “Edit
Guest Access” activity. The PA also can add a sponsor/CRO rep (with their permission) to section 1.5 of the
application, which allows provincial application to be routed to the sponsor/CRO rep to complete.
Discussion
The attendees were asked about arrangements whereby study-related activities take place at another centre/separate
legal entity – e.g., administration of standard drugs. These centres are known as affiliate centres and require
agreements with the research centre, including relevant training and reporting. The affiliate centre also needs to obtain
REB approval for its study-related activities, either by delegating to the REB of record overseeing the research centre –
process to be determined - or by submitting to their (the affiliate centre’s) local REB. No one on the call indicated that
they had a research centre/affiliate centre arrangement.
OCREB Membership Changes
The OCREB membership list was last updated on February 1, 2016. The current and archived membership lists can be
accessed from https://ocrebonline.ca under “Member Lists”.
Project Submission Summary List
The list of studies with OCREB (project submission spreadsheet) is available on the O2 Home page
https://ocrebonline.ca. The current version posted is from January 26, 2016.
OCREB ONLINE (O2)
Key Recent Enhancements
See also the “What’s New” section of O2 Home - https://ocrebonline.ca
Below are issues that have been fixed or enhancements made in the last system patch.
Patch Feb 2016:
 New automatic password reset feature. Users can click on the “Forgot Password?" link, enter their UserID and
institutional email address. Once the system validates the email address, the system will email the user with a new
temporary password. If the email address is not validated, the user will have to send a password reset request to
O2 Support at ocrebonline@oicr.on.ca..
 The CTO logo resized on O2 homepage and on letter templates. (50% reduction)
 Fixed overlapping text in the centre reviewer form for expedited reviews
 Sponsors now are able to edit amendment cover form if an amendment is sent for sponsor review.
 There will be a new email notification to notify the provincial Study Coordinator after all centres have closed, asking
them to close out the provincial application.
 Corrected the spelling of the word “receive” on the Provincial Initial Approval letter template.
 Added the description column (to show document password) to IBs in the Application Attachments tab in the main
study workspace.
 When initiating a study closure (provincial or centre), the instructions have been updated to remind users to
complete the Closure Form before submitting the study closure.
 Corrected the spelling of the word “version” on the Amendment Modifications Review letter.
 Corrected the text in the Initial Submission and Amendment Review letters. “Attached Documents – Other”.
Replaced with “OCREB Recommended Consent Form Changes”.
 Fixed text overlap in the printer version of the Reportable Event application.
 Corrected text for Meeting Reviewer Assignments notice. "Visit your personal page "My Inbox" tab to complete
your assigned reviews" has been replaced with "by logging into your 02 account and checking your 'My Action
Items' tab to access and complete your assigned reviews"
 Assent form can now be accessed from the amendment workspace attachments tab.
 The header of the Meeting Agenda and Minutes templates was corrected to reflect the current OCREB/OICR
mailing address.
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STUDY SUBMISSION STATUS
For a list of all studies with OCREB, see the Project Submission spreadsheet at https://ocrebonline.ca
New studies submitted for the January meeting:
16-001
Aurora
COG
AAML1531
Johann Hitzler
HSC
Catherine Deveault
16-002
Kathie
NCIC
IND.222
Warren Mason
UHN
Nanthini Tharahan
New studies submitted for the February meeting:
16-003
Cindy
NCIC
MA.38
Mihaela Mates
KGH
Kristina Kulik
16-004
Kathie
NCIC
MAC.19/A011202
Steven Latosinsky
LHRI
Mary Beth Husson
16-005
Aurora
NCIC
MEC.5
Teresa Petrella
SHSC
Carolyn Lim
16-006
Aurora
IIS
OTT 16-01
Mark Clemons
TOH
Sasha Mazzarello
16-007
Cindy
NCIC
IND 229
Philippe Bedard
UHN
Nanthini Tharahan
Studies in Pre Submission:
Lilly
I3Y-MC-JPBZ
Yasmin Rahim
JX594-HEP024
Leyo Ruo
HHS
Marlie Valencia
Onconova 04-30
Karen Yee
UHN
Irene Tang
GO29527
Jing Li
TEGH
Mersida Poloska
NRG
NRG-CC003
Zishan Allibhai
SRHC
Catherine Vanderwater
COG
AOST1321
Abha Gupta
HSC
Nivetha Ramachandran
18F-FDG
Katherine Zukotynski
SJHC
Janet Crouch
XL184–401
Monika Krzyzanowska
UHN
Amirah Shahin
SillJen
Genentech
IIS
Exelixis
SRHC
Priyanka Khandelwal
Other Potential Studies: N/A
CONTINUING REVIEW APPLICATIONS DUE FOR NEXT MEETING
Be sure to keep track of the expiry dates of your studies. The system sends courtesy reminders 49 days, 15 days and
1 day prior to the expiry date.
For studies expiring March 11, 2016 to April 7, 2016, inclusive, provincial and centre continuing review applications
are due by the February 23, 2016 deadline for the March 11, 2016 meeting, unless a study closure has been or will
be submitted.
Next OCREB teleconference: March 4, 2016
Teleconference 2016-Feb-05
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