Committee Minutes - Canadian Regulatory Meeting   CANADIAN REGULATORY MEETING (JANUARY 2008) John Paul-Bahary, M.D., Chair Review of Minutes The minutes of the previous meeting, 6/23/2007, were reviewed and accepted as written. Agenda Items Accrual by Canadian Institutions Dr. Bahary went over the Canadian accrual numbers and Canadian institution status for this quarter. Quality Control Audit Updates - Elaine Boyle RTOG Senior Quality Control Auditor Elaine Boyle, RTOG Senior Quality Control Auditor, mentioned the nine Canadian sites were audited this meeting period. All nine sites had acceptable audits. Elaine mentioned the upcoming audits for the next six months. The sites that will be audited are: McGill University, Center Hospitalier Universitaire de Sherbrooke, Toronto Sunnybrook Regional Cancer Centre and Cancer Care Manitoba. Dr. Jean-Paul Bahary and Dr. Alex Sun will accompany the RTOG audit team on their Canadian site visits. The audit team is looking for additional volunteers for Canadian audits. Other Business-Polling for Canadian Participation RTOG 0822 - "A Phase II Evaluation of Preoperative Chemoradiotherapy Utilizing Intensity Modulated Radiation Therapy (IMRT) in Combination with Capecitabine and Oxliplatin for Patients with Locally Advanced Rectal Cancer. Sites expressed the concern for funding for PET/CT since FDG is considered experimental in Canada. Currently there are three studies that involve PET/CT and there is Canadian participation. Sites who participate in studies involving PET/CT are to submit documentation via a No Objection Letter which states the "The Safety and Usefulness of using 18F-FDG Imaging in the practice of Oncology in a Tertiary Care Institution. The NOL is required for all sites in participation in a suitable Health Canada approved clinical study of FDG-PET, such as the open study evaluating the safety of FDG. RTOG 0621 - Adjuvant 3DCRT/IMRT in Combination with Adrogen Suppression with Docetaxel for High Risk Prostate Cancer Patients Post-Prostatectomy: A Phase II Trial. The overall concern with this study is the cost of the study agents used in this study. Sites would participate if the drug was being provided by the RTOG. The RTOG Contract Liaison will look into the feasibility in having the study agent provided for Canadian institutions. Miscellaneous: The Canadian Regulatory Associate opened the floor for any questions or concerns in relation to regulatory documents being submitted to the CTSU. Sites had no questions or concerns at this time. CANADIAN REGULATORY MEETING (JUNE 2007) John Paul-Bahary, M.D., Chair REVIEW OF MINUTES The minutes of the previous meeting, 3/3/2007, were reviewed and accepted as written. AGENDA ITEMS Dr. Bahary went over the Canadian accrual numbers and Canadian institution status for this quarter. QUALITY CONTROL AUDIT UPDATES - VAL GEISSENHAINER, RTOG QUALITY CONTROL AUDITOR Val Geissenhainer, RTOG Quality Control Auditor, discussed the four Canadian sites that were audited this meeting period: Princess Margaret Hospital, Ottawa Regional, Allan Blair, and Saint John Regional in New Brunswick. All four sites had acceptable audits. Val mentioned the upcoming audits for the remainder of the year. The sites that will be audited are: Murphy Cancer Centre, L'Hotel Dieu Quebec (their first audit as a full member), Northwestern Ontario Regional, University of Western Ontario, Grand River Regional Cancer Centre, and Cancer Care Manitoba. This will be the first audit for both Grand River Regional Cancer Centre and Cancer Care Manitoba. In response to the new requirements, the RTOG audit team has instituted a tracking system for institutional responses to audit findings in order to comply with the new timeframe set by the 2006 CTMB guidelines. The audit team has also developed a strict timeline for post-audit paperwork to assist sites with avoiding any problems with the new guidelines. Val mentioned since the new guidelines went into effect in January, 2007, RTOG has not had one late response. Val also mentioned RTOG HQ has instituted quarterly in-house RA training sessions. The RA training sessions are open to all that are interested. The training schedule will be posted on RTOG website under the RA corner. UPDATE ON CTSU DOCUMENT SUBMISSION PROJECT - ERIN CUNNINGHAM, REGULATORY SPECIALIST, CANADA Erin Cunningham, Regulatory Associate for Canadian Affairs, gave an update on the status of the CTSU regulatory document submission project. Although it was earmarked at the last meeting RTOG will go live with this initiative by late February or early March, RTOG encountered some unforeseen issues which cause the delay. As of today, everything is in order and RTOG plans to go live with initiative by mid July. RTOG will send an email to all Canadian sites when the programming is complete and they can begin submitting their documents to CTSU. MISCELLANEOUS Dr. Bahary asked if the Canadian members felt the need for more frequent contact over the year and if they would like to have HQ schedule teleconference to discuss any logistical or other issues which may arise. None felt this was necessary at this time. CANADIAN REGULATORY MEETING (FEBRUARY 2007) John Paul-Bahary, M.D., Chair ANNOUNCEMENTS Dr. Jean-Paul Bahary announced he will chair the Canadian Regulatory meeting due to the resignation of Dr. Colum Smith, Vice Chair of Canadian Affairs. Dr. Mitch Machtay discussed the changes with the resignation of Dr. Smith and the need for a new Vice Chair. Before the close of the meeting we will accept nominations for Dr. Smith's replacement. REVIEW OF MINUTES The minutes of the previous meeting, 06/24/2006, were reviewed and accepted as written. AGENDA ITEMS Introduction of new, RTOG Regulatory Associate for Canadian Affairs Wilma Hoffman, Director of Protocol Development & Regulatory Compliance, welcomed all and introduced Erin Cunningham, who has assumed the position of Regulatory Associate for Canadian Affairs. Accrual by Canadian Institutions Dr. Bahary provided an explanation of RTOG Full and Affiliate membership along with a review of the current status of Canadian Accrual. It was noted some sites were not listed on the distributed spreadsheet. Erin Cunningham will re-run the Canadian accrual report and send the updated spreadsheet to all the Canadian Institutions. "Opportunities in RTOG for Translational Research for Canadian Institutions" Dr. Rob Bristow Dr. Bristow gave a presentation regarding Translational Research and Leadership with Canadian Institutions. The presentation discussed the collaboration with CARO and RTOG in doing translational research with Health Canada. The key concepts of the presentation discussed adding value to Canada in looking at biomarkers to correlate radiation response with tissue. Dr. Bristow put emphasis that Canada can become a leader in doing an SOP in biomarkers and radiation response. Quality Control Audit Updates - Elaine Boyle, Senior RTOG QC Auditor Elaine Boyle, Senior RTOG Auditor gave an update on the new audit guidelines which were implemented by The NCI Clinical Trials Management Branch (CTMB). The new guidelines went into effect January 2007. The new guidelines are available on the RTOG website under the RA Corner. Elaine congratulated new Full Member Princess Margaret Hospital on a perfect audit. Elaine also mentioned RTOG HQ has instituted quarterly in-house RA training sessions. The RA training sessions are open to all who are interested. The training schedule will be posted on RTOG website under the RA Corner. Transitioning procedures for submitting Canadian regulatory documents through CTSU - Erin Cunningham, Regulatory Specialist, Canada Erin Cunningham, Regulatory Associate for Canadian Affairs, gave a presentation regarding transitioning procedures for Canadian institutions submitting regulatory documents through CTSU. RTOG plans to go live with this initiative by late February or early March of 2007. The premise of the initiative is to give Canadian sites access to their regulatory documents and site status for RTOG studies and to harmonize document submission for all members. Nomination of a new Canadian Regulatory Meeting Chair Dr. Walter Curran, RTOG Group Chair opened the floor for nominations of a new Vice Chair of Canadian Affairs for the Group. Dr. Jean-Paul Bahary was nominated and has accepted the position. The term will last for 3 years, and it will be non-renewable. CANADIAN REGULATORY MEETING (JUNE 2006) Colum J. Smith, M.B., Chair Attendees: B. Abdulkaram, A. Balogh, G. Couloule, L. Elliott, C. Falkson, J. Gardner, M. Grevel, C. Ho, N. Jha, I. Lee, I. Mohammed, T. Mudri, C. Nestruck, J. Pantalone, M. Perna, K. Sabate, C. Smith, A. Sun, F. Tang, F. Wong, S. Wong RTOG Headquarter representatives: E. Boyle, M. D’Amico, V. Geissenhainer, W. Hoffman, F. Osmers Dr. Smith welcomed all and introduced Christine Nestruck of Health Canada and welcomed the potential new member site representative, Dr. Islam Mohammed, from British Columbia to the meeting. He provided an explanation of RTOG full and affiliate membership along with a review of the current status of Canadian accrual. Dr. Nestruck commented on the amazing Canadian accrual figures and the reorganization of the office of clinical trials at Health Canada. She reviewed the clinical trial framework and discussed the registration and disclosure of clinical trial information which will be available on the Therapeutic Products Directorate (TPD) website. There is also work being done on an e-manual of clinical trials, which will soon be available on the TPD website as well. It was noted the RTOG, which had been left off the reorganization survey distribution list will be added before the next circulation. Dr. Stuart Wong provided a brief overview and an invitation for Canadian participation in his study, RTOG 0421. Dr. Wong also requested Canadian members consider joining the Head and Neck Cancer Committee Disease Site. Elaine Boyle, Senior RTOG Auditor, reviewed auditing issues, noting investigational agent deficiencies increased this past year. A useful handout was provided with information on working with NCI investigational agents. The Audit Program Guide 7/2006 revision will soon be available on the RTOG website. Ten Canadian audits will be conducted this year. Elaine also expressed a sincere apology to the Canadian institutions for unintentionally scheduling several audits during the July/August Canadian vacation season this year, stating the 2007 Audit Plan changes Canadian audits to take place during May/June and Sept/Oct. The NCI Clinical Trials Management Branch (CTMB) will be releasing a new manual, which will include in writing “safety reports must be submitted to the REB/IRB within 90 days” as well as information on the return of study drug. The new focus of the NCI is timely data submission. Dr. Smith mentioned the taxotere issue for RTOG 0521 had been resolved. Fred Osmers is continuing to follow up on supply issues for capecitabine and irinotecan for Canadian institutions for studies. Wilma Hoffman gave a presentation regarding the roles and responsibilities of the Study Chair, which were highlights from the most recent RTOG Study Chair Workshop. These workshops take place twice a year and are open to investigators with concepts and protocols in development. Dr. Suzanne Swann was unavailable for her scheduled presentation on Common Methodological Issues to Consider When Submitting RTOG Trial Concepts. Dr. Smith requested this presentation be moved to the next meeting agenda There was a question regarding the procedure for forming a new disease site team for lymphoma. It was determined that this required the Group Chair’s feedback. Dr. Smith informed the attendees he will be unable to attend the Tampa meeting in February 2007 and requested a volunteer to chair the meeting in his absence. None came forward so one will be sought in the interim period.