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 April 17, 2015 @ 9am ATTENDEES 1. 2. 3. 4. Sites: Hamilton Health Sciences (JCC) Lakeridge Health (Oshawa) Lawson (London) - LRCP The Ottawa Hospital Cancer Centre OHRI 5. St. Joseph’s Healthcare (Hamilton) 6. Southlake Regional Health Centre OCREB: Aurora de Borja, Janet Manzo, Safia Moosvi, Cindy Sandel, Alison van Nie, Kathie Zeman REGRETS 11. 12. 13. 14. Sites: 15. 16. 17. 18. OCREB: 7. Sunnybrook Health Sciences Centre Odette Cancer Centre SRI 8. Toronto East General 9. Trillium Health Partners - Credit Valley Hospital 10. UHN - Princess Margaret Cancer Centre Clinical Trial Support Unit Drug Development Program Cambridge Memorial Grand River Hospital Health Sciences North (Sudbury) Humber River Hospital Kingston General Hospital Mount Sinai Hospital Niagara Health System North York General Hospital 19. 20. 21. 22. 23. 24. 25. 26. Royal Victoria Regional Health Centre St. Joseph’s Health Centre (Toronto) St. Michael’s Hospital Thunder Bay Regional Health Sciences Centre Trillium Health Partners - Mississauga Hospital William Osler Health Centre Windsor Regional Hospital Women’s College Hospital Richard Sugarman (Chair), Mark Whissell (VC), Yooj Ko (VC) If you temporarily have to leave the teleconference, please hang up and dial in again when you are able to rejoin. Putting your phone on hold causes interference with all of the other lines. If you no longer wish to receive the monthly teleconference agendas and minutes, please contact Alison van Nie at alison.vannie@oicr.on.ca to be removed from the OCREB distribution list. NOTE. You will no longer receive communication from OCREB, with the exception of relevant business communication, as applicable. You may request to be reinstated in the distribution list at any time. NOTEWORTHY ITEMS A place for sharing new information, updates and other noteworthy items affecting the research community… Regulatory/Guidance Updates: 1. Use of Electronic Informed Consent (eIC) in Clinical Investigations Questions and Answers Guidance for Industry DRAFT GUIDANCE March 9, 2015 – the consultation is open for 60 day Draft Guidance 2. Apple announces that its medical research app-builder, ResearchKit, has a module for building electronic consent forms. The five apps/studies that hit the App store after Apple’s announcement all utilized remote, electronic informed consent processes that hinted at the potential for wider use. OCREB is qualified under the Clinical Trials Ontario REB Qualification Program Mount Sinai’s Icahn School of Medicine worked with LifeMap Solutions to create Asthma Health, which is studying patterns of asthma symptoms. Among other plans, the study aims to match up a participant’s report of symptom severity with the air quality at that location at that moment. Massachusetts General Hospital has designed GlucoSuccess to help manage diabetes symptoms and study how personal habits affect glucose levels. Stanford has MyHeart Counts, which track how personal habits affect cardiovascular health. MyHeart Counts monitors daily activities, tracks behavior through surveys, and correlates that data with reported cardiovascular health. Sage Bionetworks and the University of Rochester are studying Parkinson ’s disease with mPower. This study uses the iPhone’s accelerometer and touch screen to assess participants’ balance and dexterity. In collaboration with the Dan-Farber Cancer Institute, Penn Medicine, and UCLA’s Jonsson Comprehensive Cancer Center, Sage Bionetworks also has created Share the Journey, a program to track the daily impact of breast cancer. 3. World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human 2013 – nicely laid out and searchable http://jama.jamanetwork.com/article.aspx?articleid=1760318&utm_source=fbpage&utm_medium=social _jn&utm_term=164687182&utm_content=content_engagement%7Carticle_engagement&utm_campaign =article_alert&linkid=13323096#.VR9jbvcFzk0.linkedin 4. GCP-related, Access to Investigational Products: Draft Guidance- Individual Patient Expanded Access Applications For access outside of a clinical trial, by patients with serious or life-threatening diseases or conditions for which there are no comparable alternative treatments. https://www.federalregister.gov/articles/2015/02/10/2015-02561/individual-patient-expanded-accessapplications-form-fda-3926-draft-guidance-for-industry 5. WHO Calls for Increased Transparency in Medical Research 14 APRIL | 2015 WHO today issued a public statement calling for the disclosure of results from clinical trials for medical products, whatever the result. The move aims to ensure that decisions related to the safety and efficacy of vaccines, drugs and medical devices for use by populations are supported by the best available evidence. http://www.who.int/mediacentre/news/notes/2015/medical-research-transparency/en NEWSWORTHY 1. http://www.buzzfeed.com/azeenghorayshi/johns-hopkins-sued-for-1-billion-over-unethical-stdstudy#.jsaOeQOnP Guatemalans sue over research in 1940s 2. Ebola Vaccines Will Enter Phase III Soon - Two Ebola vaccines are set to enter Phase III testing in West Africa soon Read More A trial in Guinea or Sierra Leone would aim to enroll 27,000 patients. Patients will be randomized to receive either a chimp adenovirus-carried vaccine developed by the NIAID and GlaxoSmithKline, or another developed by the Public Health Agency of Canada and licensed to NewLink Genetics and Merck. 3. N2 News: N2/CAREB REB SOPs – French language version https://oicronca.box.com/s/95k7ydj574579ajvbe06 Teleconference 2015-Apr-17 Page 2 of 18 N2 – release of tools/information sheets related to HC inspections https://oicronca.box.com/s/reo8vwr0zzk0pkpqjujxbfr3xit18qr8 The much anticipated GCP refresher course is now released. CANADA_GCP_Refre Sign In CITI Generic sher_Course_AnnouncementClean 2015-03-17.pdf April 2015.pdf NOTICES Revised Consent Form Templates The current OCREB/NCIC Main ICF template has revised and the new version of the form will be posted in the next week or two (once formatting, etc., has been completed). The current OCREB ICF template also will be revised, to reflect these changes, and the new version will be posted shortly. The two documents are very similar with minor additions to the OCREB ICF to reflect specific information that has been negotiated with OCREB’s affiliated centres. The documents have not changed significantly, although the risk section has been updated to allow for options when describing the risks and there have been minor changes in wording and organization in some sections of the document. Change to Optional Consent Signature Page The optional ICF templates have been updated due to a concern/audit finding related to the date format on the signature pages and inconsistencies with the data entered. To address this finding the date formats (under the signature lines) were removed – no other changes have been made, however, the version date was updated. NRG RTOG/NRG has new data collection forms that may not be applicable for the studies conducted in Ontario. Please note that some of the information in the forms may not apply to studies conducted under OCREB – please review the approval letter to ensure that only those forms that are approved for use with the study are implemented. Brochures/Advertisements There have been increased submissions of brochures and advertisements for studies – please remember that these are considered to be participant materials which must be approved prior to implementation. Mandatory use of Templates Please note that OCREB now requires that ICFs submitted to the Board for review must use the OCREB template(s). Initial submissions that include ICFs that are not consistent with the OCREB templates may be returned to the applicant. Submission of ‘urgent’ amendment Please remember – to prevent a delay in the review and approval of urgent information - if there is an urgent amendment that requires immediate review, and an amendment already has been submitted and is under review, the applicant should contact the REC so that the previous amendment may be withdrawn or information contained in the new amendment can be added. REMINDERS Sponsor Access Please consider granting the sponsor or CRO access to their studies in O2. They need the REB information anyway, so it might save them asking the sites for the information. In order to grant them access, they must have an O2 account. If they do not have one, send their detailed contact information to O2 Support and request an account. Once they have an O2 account, use the “Edit Guest List” activity and select their name/names from a drop-down list to grant them view access. Please also consider adding a willing sponsor or CRO contact to Teleconference 2015-Apr-17 Page 3 of 18 Section 1.5 of the provincial application form (check with them first). They can be added to the application whenever it is open to the Provincial Applicant for editing, or at any time by using the “Edit Study Personnel” activity. This will allow the Provincial Applicant - using the “Send for Sponsor Review” activity - to send/route ANY provincial application to the sponsor/CRO contact listed in Section 1.5 for completion. The sponsor/CRO contact can complete the entire application including uploading any documents and use the “Submit Sponsor Review” activity to send the application back to the Provincial Applicant to review and submit. Submission of identifiers Please remember to de-identify all documents prior to submission (e.g. protocol deviations, AEs). The only study-related identifier that can be included is the study participant ID (i.e., redact all other identifiers including initials). CCO Funding - No updates. Billing Information Please obtain the correct billing information to enter into section 1.2a of the provincial application form, and update the information when applicable by editing the sponsor billing information. Billing information applies to any Industry sponsored studies submitted on or since April 2013 (starting with 13-024 but including 13-020). The contact information in this section automatically populates the invoices used to collect the review fees (for initial and annual reviews). Please ensure that the sponsor/CRO rep understands what this information is collected and used for and confirm that it is the correct billing information for Canadian sites. This is particularly important for CROs working out of the US. We have seen the CRO contact information entered into this section instead of the billing information, creating additional work and delays. OCREB MEMBERSHIP CHANGES The OCREB membership roster was last updated on April 1, 2015. However, an April 27, 2015 version will be posted after April 27. The current and archived membership lists can be accessed from O2 Home (https://ocrebonline.ca) under “Member Lists”. PROJECT SUBMISSION SUMMARY LIST The list of studies with OCREB (project submission summary spreadsheet) is available on the O2 Home page https://ocrebonline.ca. The current version posted is March 27, 2015. OCREB ONLINE (O2) Key Recent Enhancements See also the “What’s New” section of O2 Home - https://ocrebonline.ca Between March 13 and 15, a major upgrade was applied to the O2 system. Although it was relatively seamless for the end users, it involved a lot of testing and coordination behind the scenes. Thanks to Terry Liu, Safia Moosvi, the OICR IT team and the RECs for their time and effort resulting in a smooth transition. Note that Internet Explorer 11 (IE11) is now supported. See O2 Home for the list of supported browsers. Outstanding issues (logged but not yet resolved): For amendments involving a change in PI, the new PI is not able to see the study in the action items even before they accept the study. This fix will be made in a future patch. Guidance text feature for application forms and workspaces; Archiving for 25 years so system can be used as ethics study files. Teleconference 2015-Apr-17 Page 4 of 18 STUDY SUBMISSION STATUS For a list of all active studies with OCREB, see the Project Submission spreadsheet at https://ocrebonline.ca New studies submitted for the April meeting: 15-026 Cindy NRG NRG-LU001 Tsakiridis, Theo HHS Yvonne Kinrade 15-027 Kathie Polynoma 103A-301 Butler, Marcus UHN Andreea Sederias 15-028 Aurora PMHC MOBILITY-002 Bedard, Philipe UHN Bonnie Kwan 15-029 Cindy Pfizer B1371012 Wells, Richard SHSC Arlene Mete 15-030 Aurora PMHC OZM-061 Oza, Amit UHN Bonnie Kwan 15-031 Kathie AZ D0816C00009 Oza, Amit UHN Bonnie Kwan 15-032 Aurora Momenta MOM-M402-103 Moore, Malcolm UHN Anna Dodd 15-033 Cindy Merck MK-3475-061 Vincent, Mark LHSC Mary Beth Husson Studies in Pre Submission: Exelixis XL184–401 Krzyzanowska, Monika UHN Amirah Shahin INCB 18424-267 Chen, Eric UHN Bonnie Kwan 56021927PCP3001 Winquist, Eric LHSC Mary Beth Husson NCIC IND.221 Hirte, Hal HHS Yvonne Kinrade Tokai TOK-200-15 Emmenegger, Urban Bayer BAY 1000394 / 17616 Hirte, Hal Incyte Janssen SHSC HHS Jennifer Woo Yvonne Kinrade Other NCIC CTG SRC.7/Alliance 0911005: A Phase III, Double Blind, Randomized, Placebo-Controlled Trial of Sorafenib in Desmoid Tumors or Agressive Fibromatosis (DT/DF). March 20 NCIC email notice. CONTINUING REVIEW APPLICATIONS DUE FOR THE MAY MEETING – see next section 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. There are approximately 45 studies involving 130 centre applications (approximately 175 continuing review applications) due by the April 23rd deadline for the May 8th, 2015 OCREB Meeting, (i.e., expiring May 8th to June 11h 2015, inclusive), unless a study closure has been or will be submitted. Next OCREB teleconference: June 5, 2015 at 9 am The May meeting is cancelled since most of the OCREB team will be away at the CAREB national conference. Teleconference 2015-Apr-17 Page 5 of 18 CONTINUING REVIEW APPLICATIONS DUE FOR THE MAY 8th MEETING Study ID PI Centre Centre Contact Application Type Expiry Date B-42 Elser (MSH), Christine Mount Sinai Hospital Olivera Jugovic Provincial 09-May-15 07-040 Sponsor National Surgical Adjuvant Breast and Bowel Project(NSABP) National Surgical Adjuvant Breast and Bowel Project(NSABP) B-42 Elser (MSH), Christine Olivera Jugovic Centre 09-May-15 Cindy Sandel 07-041 Amgen Canada Inc. 20060342 Oza, Amit M. Riddhi Gehi Provincial 09-May-15 Cindy Sandel 07-041 Amgen Canada Inc. 20060342 Oza, Amit M. Mount Sinai Hospital UHN-Princess Margaret Cancer Centre UHN-Princess Margaret Cancer Centre Katie Allen Centre 09-May-15 Cindy Sandel 08-018 Hoffmann-La Roche Limited (Canada) BO20906 BETH Hamm, Caroline Windsor Regional Hospital Donna Clinansmith Provincial 09-May-15 Cindy Sandel 08-018 Hoffmann-La Roche Limited (Canada) BO20906 BETH Hamm, Caroline Patricia Dupuis Centre 09-May-15 Cindy Sandel 08-018 BO20906 BETH Elser (UHN), Christine Tazmin Usmani Centre 09-May-15 Cindy Sandel 08-023 26866138LYM-3002 Crump, Michael Nimisha Dave Provincial 12-May-15 Cindy Sandel 08-023 Hoffmann-La Roche Limited (Canada) Johnson & Johnson Janssen-Ortho (change to Janssen) Johnson & Johnson Janssen-Ortho (change to Janssen) 26866138LYM-3002 Crump, Michael Nimisha Dave Centre 12-May-15 Cindy Sandel 08-031 NCIC Clinical Trials Group (NCIC CTG) PRC.3 Zlotta (UHN), Alexandre R. Grace Garcia Provincial 09-May-15 Cindy Sandel 08-031 NCIC Clinical Trials Group (NCIC CTG) PRC.3 Zlotta (UHN), Alexandre R. Windsor Regional Hospital UHN-Princess Margaret Cancer Centre UHN-Princess Margaret Cancer Centre UHN-Princess Margaret Cancer Centre UHN-Princess Margaret Cancer Centre UHN-Princess Margaret Cancer Centre Grace Garcia Centre 09-May-15 Cindy Sandel 08-031 NCIC Clinical Trials Group (NCIC CTG) PRC.3 Zlotta (MSH), Alexandre R. Grace Garcia Centre 09-May-15 Cindy Sandel 09-026 Janssen Research & Development COU-AA-302 Mukherjee, Som Yvonne Kinrade Provincial 09-May-15 REC OCREB # Cindy Sandel 07-040 Cindy Sandel Teleconference 2015-Apr-17 Mount Sinai Hospital Lawson Health Research Institute(London) Page 6 of 18 Centre Contact Application Type Expiry Date Yvonne Kinrade Centre 09-May-15 Mary Beth Husson Centre 09-May-15 Katharine Devitt Provincial 09-May-15 Katharine Devitt Centre 09-May-15 Sunnybrook Health Sciences Centre Natalie Coburn Centre 09-May-15 Hamilton Health Sciences Yvonne Kinrade Provincial 09-May-15 Hamilton Health Sciences UHN-Princess Margaret Cancer Centre Lawson Health Research Institute(London) Trillium Health Partners - Credit Valley Hospital Yvonne Kinrade Centre 09-May-15 Riddhi Gehi Provincial 09-May-15 Mary Beth Husson Centre 09-May-15 Sandy Phillips Centre 09-May-15 REC OCREB # Sponsor Study ID PI Cindy Sandel 09-026 Janssen Research & Development COU-AA-302 Mukherjee, Som Cindy Sandel 09-026 Janssen Research & Development COU-AA-302 Winquist, Eric W. Aurora de Borja 09-028 UHN-Princess Margaret Cancer Centre quality improvement Wei, Alice C.C. Aurora de Borja 09-028 UHN-Princess Margaret Cancer Centre quality improvement Wei, Alice C.C. Hamilton Health Sciences Lawson Health Research Institute(London) UHN-Princess Margaret Cancer Centre UHN-Princess Margaret Cancer Centre Aurora de Borja 09-028 UHN-Princess Margaret Cancer Centre quality improvement Coburn, Natalie Cindy Sandel 09-031 Radiation Therapy Oncology Group (RTOG) RTOG 0534 Lukka, Himanshu R. Cindy Sandel 09-031 RTOG 0534 Lukka, Himanshu R. Cindy Sandel 09-032 PHL-072 Knox, Jennifer J. Cindy Sandel 09-032 PHL-072 Welch, Stephen Cindy Sandel 09-032 PHL-072 Strevel, Elizabeth Cindy Sandel 09-032 PHL-072 Hirte, Holger (Hal) W. Cindy Sandel 09-032 Radiation Therapy Oncology Group (RTOG) Princess Margaret Hospital Consortium (PMHC) Princess Margaret Hospital Consortium (PMHC) Princess Margaret Hospital Consortium (PMHC) Princess Margaret Hospital Consortium (PMHC) Princess Margaret Hospital Consortium (PMHC) PHL-072 Cindy Sandel 10-034 NCIC Clinical Trials Group (NCIC CTG) Cindy Sandel 10-034 NCIC Clinical Trials Group (NCIC CTG) Teleconference 2015-Apr-17 Centre Yvonne Kinrade Centre 09-May-15 Knox, Jennifer J. Hamilton Health Sciences UHN-Princess Margaret Cancer Centre Smitha Udagani Centre 09-May-15 IND.202 Petrella, Teresa Marie Sunnybrook Health Sciences Centre Carolyn Lim Provincial 09-May-15 IND.202 Song, Xinni The Ottawa Hospital Lisa Turriff Centre 09-May-15 Page 7 of 18 Centre Contact Application Type Expiry Date Carolyn Lim Centre 09-May-15 Mary Beth Husson Centre 09-May-15 Hamilton Health Sciences Yvonne Kinrade Centre 09-May-15 Verma, Shailendra The Ottawa Hospital Amy Henderson Provincial 09-May-15 20060359 (DCare) Sehdev, Sandeep R. William Osler Health Centre Johnson Dartey Centre 09-May-15 Amgen Canada Inc. 20060359 (DCare) Mates, Mihaela Kingston General Hospital Carrie Lindsay Centre 09-May-15 10-035 Amgen Canada Inc. 20060359 (DCare) Bin, James Christine Stewart Centre 09-May-15 10-035 Amgen Canada Inc. Centre 09-May-15 10-035 Amgen Canada Inc. 20060359 (DCare) 20060359 (DCare) Centre 09-May-15 10-035 Amgen Canada Inc. 20060359 (DCare) Califaretti, Nadia B. 10-039 NCIC Clinical Trials Group (NCIC CTG) 10-039 NCIC Clinical Trials Group (NCIC CTG) 10-039 NCIC Clinical Trials Group (NCIC CTG) Aurora de Borja 10-039 NCIC Clinical Trials Group (NCIC CTG) Aurora de Borja 10-039 NCIC Clinical Trials Group (NCIC CTG) REC OCREB # Sponsor Study ID PI Centre Cindy Sandel 10-034 NCIC Clinical Trials Group (NCIC CTG) IND.202 Petrella, Teresa Marie Cindy Sandel 10-034 NCIC Clinical Trials Group (NCIC CTG) IND.202 Ernst, Scott Sunnybrook Health Sciences Centre Lawson Health Research Institute(London) Cindy Sandel 10-034 NCIC Clinical Trials Group (NCIC CTG) IND.202 McWhirter, Elaine Aurora de Borja 10-035 Amgen Canada Inc. 20060359 (DCARE) Aurora de Borja 10-035 Amgen Canada Inc. Aurora de Borja 10-035 Aurora de Borja Aurora de Borja Aurora de Borja Aurora de Borja Aurora de Borja Aurora de Borja Aurora de Borja Teleconference 2015-Apr-17 El-Maraghi, Robert Verma, Shailendra Toronto East General Hospital Royal Victoria Regional Health Centre The Ottawa Hospital Christine Di Marco Amy Henderson Carol Ballantyne Centre 09-May-15 MA.32 Goodwin (UHN), Pamela Grand River Hospital UHN-Princess Margaret Cancer Centre Anna Malik Provincial 09-May-15 MA.32 Goodwin (MSH), Pamela Mount Sinai Hospital Olivera Jugovic Centre 09-May-15 Rahim, Yasmin Southlake Regional Health Centre Priyanka Khandelwal Centre 09-May-15 MA.32 Hamm, Caroline Windsor Regional Hospital Jane Coulter Centre 09-May-15 MA.32 Segal, Roanne J. The Ottawa Hospital Lisa Turriff Centre 09-May-15 MA.32 Page 8 of 18 REC OCREB # Sponsor Study ID PI Centre Centre Contact Application Type Expiry Date Aurora de Borja 10-039 NCIC Clinical Trials Group (NCIC CTG) MA.32 Bahl, Mala Grand River Hospital Carol Ballantyne Centre 09-May-15 Aurora de Borja 10-039 NCIC Clinical Trials Group (NCIC CTG) MA.32 Freedman , Orit Aurora de Borja 10-039 NCIC Clinical Trials Group (NCIC CTG) MA.32 Aurora de Borja 10-039 NCIC Clinical Trials Group (NCIC CTG) Aurora de Borja 10-039 Aurora de Borja Edeliza Mendoza Centre 09-May-15 Goodwin (UHN), Pamela Lakeridge Health UHN-Princess Margaret Cancer Centre Anna Malik Centre 09-May-15 MA.32 Mukherjee, Som Hamilton Health Sciences Yvonne Kinrade Centre 09-May-15 NCIC Clinical Trials Group (NCIC CTG) MA.32 Mates, Mihaela Carrie Lindsay Centre 09-May-15 10-039 NCIC Clinical Trials Group (NCIC CTG) MA.32 Vandenberg, Theodore A. Mary Beth Husson Centre 09-May-15 Aurora de Borja 10-039 NCIC Clinical Trials Group (NCIC CTG) MA.32 Myers, Robert E. Helena Wong Centre 09-May-15 Aurora de Borja 10-039 NCIC Clinical Trials Group (NCIC CTG) MA.32 Haq, Rashida Aurora de Borja 10-039 NCIC Clinical Trials Group (NCIC CTG) MA.32 Aurora de Borja 10-039 NCIC Clinical Trials Group (NCIC CTG) Aurora de Borja 10-039 Aurora de Borja Kingston General Hospital Lawson Health Research Institute(London) Trillium Health Partners - Credit Valley Hospital Aziz Jiwajee Centre 09-May-15 Dueck, Dorie-Anna C. St. Michael's Hospital Thunder Bay Regional Health Sciences Centre Carol Pelletier Centre 09-May-15 MA.32 Pritchard, Kathleen I. Sunnybrook Health Sciences Centre Carolyn Lim Centre 09-May-15 NCIC Clinical Trials Group (NCIC CTG) MA.32 Findlay, Brian Peter Linda Illes Centre 09-May-15 10-039 NCIC Clinical Trials Group (NCIC CTG) MA.32 Gapski, John A.P. Niagara Health System Trillium Health Partners Mississauga Hospital Kathryn Zurawel Centre 09-May-15 Aurora de Borja 10-039 NCIC Clinical Trials Group (NCIC CTG) MA.32 Bin, James Toronto East General Hospital Christine Stewart Centre 09-May-15 Aurora de Borja 10-039 NCIC Clinical Trials Group (NCIC CTG) MA.32 Chouinard, Edmond E. Cambridge Memorial Hospital Stephanie Evans Centre 09-May-15 Teleconference 2015-Apr-17 Page 9 of 18 REC OCREB # Sponsor Study ID PI Centre Centre Contact Application Type Expiry Date Cindy Sandel 10-040 Hoffmann-La Roche Limited (Canada) BO22589 Glenns, Vivian P. North York General Hospital Anne Abraham Provincial 09-May-15 Cindy Sandel 10-040 Hoffmann-La Roche Limited (Canada) BO22589 Glenns, Vivian P. North York General Hospital Anne Abraham Centre 09-May-15 Kathie Zeman 10-043 Radiation Therapy Oncology Group (RTOG) RTOG 0848 Pantarotto, Jason The Ottawa Hospital Amy Henderson Provincial 09-May-15 Kathie Zeman 10-043 Radiation Therapy Oncology Group (RTOG) RTOG 0848 Pantarotto, Jason Amy Henderson Centre 09-May-15 Kathie Zeman 10-043 Radiation Therapy Oncology Group (RTOG) RTOG 0848 Fisher, Barbara J. Mary Beth Husson Centre 09-May-15 Cindy Sandel 10-044 PMH Drug Development Program (PMHDDP) PMH DDP CRCLM1 MacKay, Helen J. The Ottawa Hospital Lawson Health Research Institute(London) UHN-Princess Margaret Cancer Centre Smitha Udagani Provincial 09-May-15 Cindy Sandel 10-044 PMH Drug Development Program (PMHDDP) PMH DDP CRCLM1 Burkes, Ronald Louis Mount Sinai Hospital Janet Smith Centre 09-May-15 Cindy Sandel 10-044 PMH Drug Development Program (PMHDDP) PMH DDP CRCLM1. Ko, Yoo-Joung (Yooj) Adam Lam Centre 09-May-15 Cindy Sandel 10-044 PMH Drug Development Program (PMHDDP) PMH DDP CRCLM1. MacKay, Helen J. Sunnybrook Health Sciences Centre UHN-Princess Margaret Cancer Centre Silvi Kuld Centre 09-May-15 Cindy Sandel 10-044 PMH Drug Development Program (PMHDDP) PMH DDP CRCLM1. Asmis, Tim Amy Henderson Centre 09-May-15 Cindy Sandel 10-044 PMH Drug Development Program (PMHDDP) PMH DDP CRCLM1. Welch, Stephen Mary Beth Husson Centre 09-May-15 Kathie Zeman 10-050 UHN-Princess Margaret Cancer Centre CAMN107YCA 03T Schuh, Andre Alexis Vaughan Provincial 20-May-15 Kathie Zeman 10-050 UHN-Princess Margaret Cancer Centre CAMN107YCA 03T Schuh, Andre Alexis Vaughan Centre 20-May-15 Aurora de Borja 10-053 NCIC Clinical Trials Group (NCIC CTG) IND.198 Welch, Stephen Mary Beth Husson Provincial 14-May-15 Teleconference 2015-Apr-17 The Ottawa Hospital Lawson Health Research Institute(London) UHN-Princess Margaret Cancer Centre UHN-Princess Margaret Cancer Centre Lawson Health Research Institute(London) Page 10 of 18 REC OCREB # Sponsor Study ID PI Aurora de Borja 10-053 NCIC Clinical Trials Group (NCIC CTG) IND.198 Mates, Mihaela Aurora de Borja 10-055 NCIC Clinical Trials Group (NCIC CTG) IND.195 Sridhar (UHN), Srikala S. Aurora de Borja 10-055 NCIC Clinical Trials Group (NCIC CTG) IND.195 Sridhar (UHN), Srikala S. Cindy Sandel 11-023 Ontario Clinical Oncology Group(OCOG) OCOG-2011BRACHY Wright, James R. Cindy Sandel 11-023 Ontario Clinical Oncology Group(OCOG) OCOG-2011BRACHY Cindy Sandel 11-023 Ontario Clinical Oncology Group(OCOG) Cindy Sandel 11-023 Cindy Sandel Centre Contact Application Type Expiry Date Carrie Lindsay Centre 14-May-15 Ida Lee Provincial 26-May-15 Ida Lee Centre 26-May-15 Centre Kingston General Hospital UHN-Princess Margaret Cancer Centre UHN-Princess Margaret Cancer Centre Yvonne Kinrade Provincial 09-May-15 Yu, Edward Hamilton Health Sciences Lawson Health Research Institute(London) Deb Lewis Centre 09-May-15 OCOG-2011BRACHY Pan, Ming Windsor Regional Hospital Patricia Dupuis Centre 09-May-15 Ontario Clinical Oncology Group(OCOG) OCOG-2011BRACHY Falkson, Conrad B. Kristina Kulik Centre 09-May-15 11-023 Ontario Clinical Oncology Group(OCOG) OCOG-2011BRACHY Elantholiparamesw aran, Saibishkumar Kingston General Hospital UHN-Princess Margaret Cancer Centre Anna Malik Centre 09-May-15 Cindy Sandel 11-023 Ontario Clinical Oncology Group(OCOG) OCOG-2011BRACHY Rachakonda , Ramana Grand River Hospital Carol Ballantyne Centre 09-May-15 Cindy Sandel 11-023 Ontario Clinical Oncology Group(OCOG) OCOG-2011BRACHY Wright, James R. Yvonne Kinrade Centre 09-May-15 Aurora de Borja 11-024 Merck Canada Inc. MK-1775-004 Oza, Amit M. Hamilton Health Sciences UHN-Princess Margaret Cancer Centre Karen Chang Provincial 09-May-15 Aurora de Borja 11-024 Merck Canada Inc. MK-1775-004 Hirte, Holger (Hal) W. Aurora de Borja 11-024 Merck Canada Inc. MK-1775-004 Aurora de Borja 11-024 Merck Canada Inc. MK-1775-004 Teleconference 2015-Apr-17 Yvonne Kinrade Centre 09-May-15 Oza, Amit M. Hamilton Health Sciences UHN-Princess Margaret Cancer Centre Karen Chang Centre 09-May-15 Weberpals, Johanne The Ottawa Hospital Femina Kanji Centre 09-May-15 Page 11 of 18 Centre Contact Application Type Expiry Date Mary Beth Husson Centre 09-May-15 Karen Chang Provincial 09-May-15 Karen Chang Centre 09-May-15 Sunnybrook Health Sciences Centre Adam Lam Centre 09-May-15 Hamm, Caroline Windsor Regional Hospital Patricia Dupuis Provincial 09-May-15 CAMN107E24 01 Leber, Brian F. Hamilton Health Sciences Yvonne Kinrade Centre 09-May-15 CAMN107E24 01 Kuruvilla, Philip William Osler Health Centre Johnson Dartey Centre 09-May-15 CAMN107E24 01 Hamm, Caroline Patricia Dupuis Centre 09-May-15 CAMN107E24 01 Xenocostas, Anargyros Maisam Abouzeenni Centre 09-May-15 CAMN107E24 01 Nay , Derek Christine Di Marco Centre 09-May-15 CSOM230I220 1 Krzyzanowska, Monika Jayalakshmi Ramanna Provincial 26-May-15 CSOM230I220 1 Krzyzanowska, Monika Windsor Regional Hospital Lawson Health Research Institute(London) Royal Victoria Regional Health Centre UHN-Princess Margaret Cancer Centre UHN-Princess Margaret Cancer Centre Jayalakshmi Ramanna Centre 26-May-15 IND.205 Hotte, Sébastien J. Hamilton Health Sciences Yvonne Kinrade Provincial 09-May-15 REC OCREB # Sponsor Study ID PI Aurora de Borja 11-024 MK-1775-004 Welch, Stephen Kathie Zeman 11-025 OTSUKA 28711-201 Moore, Malcolm J. Kathie Zeman 11-025 OTSUKA 28711-201 Moore, Malcolm J. Kathie Zeman 11-025 OTSUKA 28711-201 Ko, Yoo-Joung (Yooj) Aurora de Borja 11-027 CAMN107E24 01 Aurora de Borja 11-027 Aurora de Borja 11-027 Aurora de Borja 11-027 Aurora de Borja 11-027 Aurora de Borja 11-027 Aurora de Borja 11-029 Aurora de Borja 11-029 Merck Canada Inc. Otsuka Pharmaceutical Development & Commercialization Inc. Otsuka Pharmaceutical Development & Commercialization Inc. Otsuka Pharmaceutical Development & Commercialization Inc. Novartis Pharmaceuticals Canada Inc. Novartis Pharmaceuticals Canada Inc. Novartis Pharmaceuticals Canada Inc. Novartis Pharmaceuticals Canada Inc. Novartis Pharmaceuticals Canada Inc. Novartis Pharmaceuticals Canada Inc. Novartis Pharmaceuticals Canada Inc. Novartis Pharmaceuticals Canada Inc. Centre Lawson Health Research Institute(London) UHN-Princess Margaret Cancer Centre UHN-Princess Margaret Cancer Centre Cindy Sandel 11-035 NCIC Clinical Trials Group (NCIC CTG) Teleconference 2015-Apr-17 Page 12 of 18 Centre Contact Application Type Expiry Date Mary Beth Husson Centre 09-May-15 Nanthini Tharahan Centre 09-May-15 Hamilton Health Sciences Yvonne Kinrade Centre 09-May-15 Gregg, Richard W. Kingston General Hospital Carrie Lindsay Centre 09-May-15 E7389-G000398 Verma, Shailendra The Ottawa Hospital Amy Henderson Provincial 09-May-15 Eisai Inc. E7389-G000398 Warner, Ellen Sunnybrook Health Sciences Centre Jeffrey Pham Centre 09-May-15 11-036 Eisai Inc. E7389-G000398 Brezden-Masley, Christine St. Michael's Hospital Aziz Jiwajee Centre 09-May-15 Aurora de Borja 11-036 Eisai Inc. E7389-G000398 Verma, Shailendra The Ottawa Hospital Amy Henderson Centre 09-May-15 Kathie Zeman 12-020 GlaxoSmithKline MEK116513 Song, Xinni The Ottawa Hospital Lisa Turriff Provincial 09-May-15 Kathie Zeman 12-020 GlaxoSmithKline MEK116513 Petrella, Teresa Marie Sunnybrook Health Sciences Centre Carolyn Lim Centre 09-May-15 Kathie Zeman 12-020 GlaxoSmithKline MEK116513 Song, Xinni The Ottawa Hospital Lisa Turriff Centre 09-May-15 Kathie Zeman 12-020 MEK116513 Baetz, Tara Kingston General Hospital Carrie Lindsay Centre 09-May-15 Kathie Zeman 12-021 CP20-0903 Eisen, Andrea The Ottawa Hospital Jeffrey Pham Provincial 09-May-15 Kathie Zeman 12-021 GlaxoSmithKline ImClone Systems (subsidiary of Eli Lilly and Company) ImClone Systems (subsidiary of Eli Lilly and Company) CP20-0903 Eisen, Andrea Sunnybrook Health Sciences Centre Jeffrey Pham Centre 09-May-15 REC OCREB # Sponsor Study ID PI Cindy Sandel 11-035 NCIC Clinical Trials Group (NCIC CTG) IND.205 Winquist, Eric W. Cindy Sandel 11-035 NCIC Clinical Trials Group (NCIC CTG) IND.205 Joshua, Anthony Centre Lawson Health Research Institute(London) UHN-Princess Margaret Cancer Centre Cindy Sandel 11-035 NCIC Clinical Trials Group (NCIC CTG) IND.205 Hotte, Sébastien J. Cindy Sandel 11-035 NCIC Clinical Trials Group (NCIC CTG) IND.205 Aurora de Borja 11-036 Eisai Inc. Aurora de Borja 11-036 Aurora de Borja Teleconference 2015-Apr-17 Page 13 of 18 Centre Contact Application Type Expiry Date The Ottawa Hospital UHN-Princess Margaret Cancer Centre Amy Henderson Provincial 09-May-15 Sujata Pokhrel Centre 09-May-15 Amy Henderson Centre 09-May-15 Bedard, Philippe The Ottawa Hospital UHN-Princess Margaret Cancer Centre Gayathri Baranage Provincial 09-May-15 CBKM120F230 2 Chouinard, Edmond E. Cambridge Memorial Hospital Stephanie Evans Centre 09-May-15 CBKM120F230 2 Trudeau, Maureen E. Sunnybrook Health Sciences Centre Jeffrey Pham Centre 09-May-15 CBKM120F230 2 Rahim, Yasmin H. Southlake Regional Health Centre Priyanka Khandelwal Centre 09-May-15 CBKM120F230 2 Clemons, Mark J. Amy Henderson Centre 09-May-15 CBKM120F230 2 Bedard, Philippe Gayathri Baranage Centre 09-May-15 CBKM120F230 2 Vandenberg, Theodore A. The Ottawa Hospital UHN-Princess Margaret Cancer Centre Lawson Health Research Institute(London) Mary Beth Husson Centre 09-May-15 Hoffmann-La Roche Limited (Canada) BO27952 Shao, Richard Heng-Fu William Osler Health Centre Christine Stewart Provincial 09-May-15 12-024 Hoffmann-La Roche Limited (Canada) BO27952 Shao, Richard Heng-Fu Toronto East General Hospital Christine Stewart Centre 09-May-15 Aurora de Borja 12-024 Hoffmann-La Roche Limited (Canada) BO27952 Brezden-Masley, Christine St. Michael's Hospital Aziz Jiwajee Centre 09-May-15 Kathie Zeman 12-025 Agensys Inc. 2008002 Ko, Yoo-Joung (Yooj) Sunnybrook Health Sciences Centre Adam Lam Provincial 09-May-15 REC OCREB # Sponsor Study ID PI Kathie Zeman 12-022 NCIC Clinical Trials Group (NCIC CTG) IND.208 Jonker, Derek J. Kathie Zeman 12-022 NCIC Clinical Trials Group (NCIC CTG) IND.208 Chen, Eric (Xueyu) Kathie Zeman 12-022 IND.208 Jonker, Derek J. Cindy Sandel 12-023 CBKM120F23 02 Cindy Sandel 12-023 Cindy Sandel 12-023 Cindy Sandel 12-023 Cindy Sandel 12-023 Cindy Sandel 12-023 Cindy Sandel 12-023 NCIC Clinical Trials Group (NCIC CTG) Novartis Pharmaceuticals Canada Inc. Novartis Pharmaceuticals Canada Inc. Novartis Pharmaceuticals Canada Inc. Novartis Pharmaceuticals Canada Inc. Novartis Pharmaceuticals Canada Inc. Novartis Pharmaceuticals Canada Inc. Novartis Pharmaceuticals Canada Inc. Aurora de Borja 12-024 Aurora de Borja Teleconference 2015-Apr-17 Centre Page 14 of 18 Centre Contact Application Type Expiry Date Adam Lam Centre 09-May-15 Kelly Brooks Provincial 09-May-15 Hamilton Health Sciences Yvonne Kinrade Provincial 09-May-15 Ko, Yoo-Joung (Yooj) Sunnybrook Health Sciences Centre Adam Lam Centre 09-May-15 EMR200592001 McWhirter, Elaine Hamilton Health Sciences Yvonne Kinrade Centre 09-May-15 Merck KGaA US Division (EMD Serono Inc.) EMR200592001 Shim, Katharine Edeliza Mendoza Centre 09-May-15 13-027 Bristol-Myers Squibb Canada CA209067 Hogg, David Avneet Grewal Provincial 09-May-15 Kathie Zeman 13-027 Bristol-Myers Squibb Canada CA209067 Hogg, David Kathie Zeman 13-027 Bristol-Myers Squibb Canada CA209067 Kathie Zeman 13-027 Bristol-Myers Squibb Canada Kathie Zeman 13-028 Kathie Zeman REC OCREB # Sponsor Study ID PI Centre Kathie Zeman 12-025 Agensys Inc. 2008002 Ko, Yoo-Joung (Yooj) Cindy Sandel 12-027 Incyte Corporation INCB 24360210 Oza, Amit M. Sunnybrook Health Sciences Centre UHN-Princess Margaret Cancer Centre Kathie Zeman 13-026 Merck KGaA US Division (EMD Serono Inc.) EMR200592001 McWhirter, Elaine Kathie Zeman 13-026 Merck KGaA US Division (EMD Serono Inc.) EMR200592001 Kathie Zeman 13-026 Merck KGaA US Division (EMD Serono Inc.) Kathie Zeman 13-026 Kathie Zeman Avneet Grewal Centre 09-May-15 Ernst, Scott Lakeridge Health UHN-Princess Margaret Cancer Centre UHN-Princess Margaret Cancer Centre Lawson Health Research Institute(London) Mary Beth Husson Centre 09-May-15 CA209067 Song, Xinni The Ottawa Hospital Lisa Turriff Centre 09-May-15 NCIC Clinical Trials Group (NCIC CTG) CRC.7 Auer, Rebecca Ann Amy Henderson Provincial 09-May-15 13-028 NCIC Clinical Trials Group (NCIC CTG) CRC.7 Welch, Stephen The Ottawa Hospital Lawson Health Research Institute(London) Mary Beth Husson Centre 09-May-15 Kathie Zeman 13-028 NCIC Clinical Trials Group (NCIC CTG) CRC.7 Auer, Rebecca Ann The Ottawa Hospital Amy Henderson Centre 09-May-15 Kathie Zeman 13-028 NCIC Clinical Trials Group (NCIC CTG) CRC.7 Findlay, Brian Peter Niagara Health System Linda Illes Centre 09-May-15 Teleconference 2015-Apr-17 Page 15 of 18 REC OCREB # Sponsor Study ID PI Kathie Zeman 13-029 NCIC Clinical Trials Group (NCIC CTG) LY.15 Crump, Michael Kathie Zeman 13-029 NCIC Clinical Trials Group (NCIC CTG) LY.15 Cheung , Matthew Kathie Zeman 13-029 NCIC Clinical Trials Group (NCIC CTG) LY.15 Crump, Michael Aurora de Borja 13-031 University Health Network(sponsor) MAST_01 Fleshner, Neil Aurora de Borja 13-031 University Health Network(sponsor) MAST_01 Shayegan, Bobby Aurora de Borja 13-031 University Health Network(sponsor) MAST_01 Fleshner, Neil Aurora de Borja 13-031 University Health Network(sponsor) MAST_01 Breau, Rodney Aurora de Borja 13-031 University Health Network(sponsor) MAST_01 Izawa, Jonathan I Aurora de Borja 13-031 MAST_01 Leveridge, Michael Aurora de Borja 14-015 PHL-093 / NCI 9568 Oza, Amit M. Aurora de Borja 14-015 PHL-093 / NCI 9568 Oza, Amit M. Aurora de Borja 14-015 PHL-093 / NCI 9568 Weberpals, Johanne Aurora de Borja 14-015 PHL-093 / NCI 9568 Welch, Stephen Teleconference 2015-Apr-17 University Health Network(sponsor) Princess Margaret Hospital Consortium (PMHC) Princess Margaret Hospital Consortium (PMHC) Princess Margaret Hospital Consortium (PMHC) Princess Margaret Hospital Consortium (PMHC) Centre UHN-Princess Margaret Cancer Centre Sunnybrook Health Sciences Centre UHN-Princess Margaret Cancer Centre UHN-Princess Margaret Cancer Centre St. Joseph's Healthcare Hamilton UHN-Princess Margaret Cancer Centre Centre Contact Application Type Expiry Date Nimisha Dave Provincial 09-May-15 Arlene Mete Centre 09-May-15 Nimisha Dave Centre 09-May-15 Sanjna Kapoor Provincial 09-May-15 Liz Sidorkewicz Centre 09-May-15 Sanjna Kapoor Centre 09-May-15 Sonya Cnossen Centre 09-May-15 Lee-Anne Fochesato Centre 09-May-15 Joe Downey Centre 09-May-15 Karen Chang Provincial 09-May-15 Karen Chang Centre 09-May-15 Lisa Turriff Centre 09-May-15 Mary Beth Husson Centre 09-May-15 The Ottawa Hospital Lawson Health Research Institute(London) Kingston General Hospital UHN-Princess Margaret Cancer Centre UHN-Princess Margaret Cancer Centre The Ottawa Hospital Lawson Health Research Institute(London) Page 16 of 18 REC OCREB # Sponsor Study ID PI Kathie Zeman 14-018 AbbVie Corporation M11-089 Liu, Geoffrey Kathie Zeman 14-018 AbbVie Corporation M11-089 Vincent, Mark David Kathie Zeman 14-018 AbbVie Corporation M11-089 Ellis, Peter Kathie Zeman 14-018 AbbVie Corporation M11-089 Kathie Zeman 14-018 AbbVie Corporation Kathie Zeman 14-019 Kathie Zeman Centre UHN-Princess Margaret Cancer Centre Lawson Health Research Institute(London) Centre Contact Application Type Expiry Date Mary Tannourji Provincial 09-May-15 Mary Beth Husson Centre 09-May-15 Yvonne Kinrade Centre 09-May-15 Liu, Geoffrey Hamilton Health Sciences UHN-Princess Margaret Cancer Centre Nicole PereraLow Centre 09-May-15 M11-089 Wheatley-Price, Paul The Ottawa Hospital Amy Henderson Centre 09-May-15 Bayer Healthcare Bayer 15396 Malone, Shawn The Ottawa Hospital Lisa Turriff Provincial 09-May-15 14-019 Bayer Healthcare Bayer 15396 Berry, Scott Sunnybrook Health Sciences Centre Jennifer Woo Centre 09-May-15 Kathie Zeman 14-019 Bayer Healthcare Bayer 15396 Malone, Shawn The Ottawa Hospital Femina Kanji Centre 09-May-15 Kathie Zeman 14-019 Bayer Healthcare Bayer 15396 Lukka, Himanshu R. Hamilton Health Sciences Yvonne Kinrade Centre 09-May-15 Aurora de Borja 14-020 Ottawa Hospital Research Institute OHSNREB 20130563-01H Carrier, Marc The Ottawa Hospital Isabel Dao Provincial 09-May-15 Aurora de Borja 14-020 Ottawa Hospital Research Institute OHSNREB 20130563-01H Yeo, Erik UHN-Toronto General Hospital Peregrina Peralta Centre 09-May-15 Aurora de Borja 14-020 Ottawa Hospital Research Institute OHSNREB 20130563-01H Carrier, Marc The Ottawa Hospital Isabel Dao Centre 09-May-15 Aurora de Borja 14-020 Ottawa Hospital Research Institute OHSNREB 20130563-01H Gross, Peter Pamela Stevens Centre 09-May-15 Aurora de Borja 14-021 Lawson Health Research Institute PET CRPC Winquist, Eric W. Mary Beth Husson Provincial 09-May-15 Teleconference 2015-Apr-17 Hamilton Health Sciences Lawson Health Research Institute(London) Page 17 of 18 Centre Contact Application Type Expiry Date Winquist, Eric W. Centre Lawson Health Research Institute(London) Mary Beth Husson Centre 09-May-15 9785-CL-1121 Trudeau, Maureen E. Sunnybrook Health Sciences Centre Carolyn Lim Provincial 09-May-15 Astellas Pharma Global Development Inc. 9785-CL-1121 Trudeau, Maureen E. Sunnybrook Health Sciences Centre Carolyn Lim Centre 09-May-15 14-022 Astellas Pharma Global Development Inc. 9785-CL-1121 Song, Xinni The Ottawa Hospital Amy Henderson Centre 09-May-15 Kathie Zeman 14-023 Hoffmann-La Roche Limited (Canada) BO28984 Cheema, Parneet Sunnybrook Health Sciences Centre Ilda Carvalhana Provincial 09-May-15 Kathie Zeman 14-023 Hoffmann-La Roche Limited (Canada) BO28984 Burkes, Ronald Louis Mount Sinai Hospital Janet Smith Centre 09-May-15 Kathie Zeman 14-023 Hoffmann-La Roche Limited (Canada) BO28984 Cheema, Parneet Sunnybrook Health Sciences Centre Ilda Carvalhana Centre 09-May-15 REC OCREB # Sponsor Study ID PI Aurora de Borja 14-021 Lawson Health Research Institute PET CRPC Kathie Zeman 14-022 Astellas Pharma Global Development Inc. Kathie Zeman 14-022 Kathie Zeman Teleconference 2015-Apr-17 Page 18 of 18