Conducting Clinical Trials in Canada
A Uniquely Canadian Perspective For all Clinical Research Professionals
June 2018 Agenda
2019 Agenda Coming Soon!
8:00-8:30 Registration and Continental Breakfast (provided)
8:30-9:30 Enhancing Human Research Protection in Canada through Accreditation
Janice Parente, PhD, President and CEO, Orion Human Research Accreditation Inc.
- What is accreditation?
- Canadian accreditation of animal research and clinical care
- Evolution of Canada’s protection of human research participants
- Canada-wide accreditation for human research
- Benefits of human research accreditation
9:30-10:30 Cannabis Research Landscape in Canada
Ilana Platt, PhD, VP, Innovation & Global Regulatory Affairs, CannTrust Inc.
Dr. Platt will focus on aspects of clinical research on cannabis that are unique to Canadians. It will include a review of where things are now and what the future holds for cannabis clinical research. A historical landscape of cannabis research also will be discussed.
10:45-11:30 Single REB Review for Multi-Centre Research: The Good, the Bad and the Ugly
Sharon Freitag, BSc., Director, Research Ethics Office, St. Michael’s Hospital
Ms. Freitag will discuss the experience of using a Board of Record model for multi-centre research and the benefits and challenges experienced. Ms. Freitag will present strategies for working with investigators and institutions when using a single REB .
11:30-12:30 The practical application of Canadian privacy legislation on clinical trials
Patricia Kosseim, Counsel, Privacy & Data Management Co-Lead, Access Privacy, Osler, Hoskin & Harcourt LLP
12:30-1:30 Lunch (provided)
1:30-3:00 PHASE IV Trials: Distinguishing Meaningful Research from Marketing Tactics
Martin Letendre, LLB, LLM, President, ethica Group of Companies
Murray Jensen, MSc, Managing Director, ethica Group of Companies
Through this presentation the participants will be invited to look at different case studies of study protocols and synopsis of Phase IV research that did not meet the standards of Innovative Medicine Canada’s Code of Ethics. Participants will have the opportunity to identify the potential scientific, ethical and societal issues pertaining to Phase IV research. The presentation will finally explore how the design of seeding trials could be modified in order to generate meaningful scientific data.
3:15-4:15 Exploring challenges to conducting investigator-initiated clinical trials.
Curtis Dumonceaux, BSc, RRT, RCPT(P), CCRP, Clinical Research Associate, University of Calgary
Mr. Dumonceaux will identify differences and similarities between Investigator Initiated and Industry sponsored clinical trials. He will discuss challenges unique to the conduct of an investigator initiated trials as well as pitfalls to avoid when designing and implementing IIS
8:15-8:30 Continental Breakfast (provided)
8:30-9:30 Network of Networks (N2): An overview of resources available to Canadian clinical research professionals.
Erin Cherban, MSc, CCRP, Chief Clinical Research Officer, Centre for Health Evaluation & Outcome Sciences
N2 is an alliance of 125 Canadian research networks and organizations working together to enhance national clinical capability and capacity. Membership in this alliance provides access to best-in-class tools and content to help ensure efficient and high-quality research, and integrity of clinical practices. Ms. Cherban will provide an overview of N2 member benefits.
9:30-10:30 Negotiating a Reasonable Allocation of Risk in CTAs (and why the new mCTA falls short)
Marlon Rajakaruna, BA, MBA, LLB, CCRP, Partner, Global & Nat'l Co-Leader of Life Sciences, Dentons Canada LLP
Negotiating the liability sections of a CTA is often the most challenging task facing CTA negotiators. Mr. Rajakaruna will identify and describe how to negotiate a reasonable allocation of risk and liabilities for your site. Topics covered will include subject injury reimbursement, indemnification, insurance and limitation of liability. For attendees not involved in CTA negotiations this presentation may still be of value, especially for study personnel who want to know if the CTA properly protects their interests. The presentation will also include detailed suggestions for assuring that the new Canadian mCTA will meet your organization’s need to have a Reasonable Allocation of Risk.
10:45-12:00 ICH / GCP
Jacqueline Busheikin, CCRP, Independent CRA, JANA Research Consulting Inc
Ms. Busheikin will give an interactive presentation on core principles of ICH/GCP.
12:00-1:00 Lunch (provided)
1:00-2:00 The Tri-Council Policy Statement: What you need to know and why
David McLauchlan, M.Sc., LL.B, Chair; Senior advisor, legal affairs, Veritas IRB; TransMedTech Institute
Promulgated by Canada’s three federal granting agencies, the Tri-Council Policy Statement (TCPS) is sometimes regarded as a mere guideline for academic research. In reality, it applies to a wide range of research, including industry-sponsored clinical trials, in a variety of settings. Mr McLauchlan will introduce the TCPS’ main requirements applicable to clinical trials and highlight divergences with the ICH-GCP.
2:00-3:00 The Controlled Drugs and Substances Act: Implications for Clinical Research
Gregory Staios, MSc, CCRP, Research Quality Improvement Specialist, Centre for Addiction and Mental Health
Mr. Staios will give the attendee a greater understanding of the regulatory framework surrounding the use of controlled substances in research, provide guidance regarding completion and submission of a Controlled Drugs and Substances Act Section 56 Exemption and learn about drug sourcing and importation procedures for academic studies.
3:15-4:15 How to Make Your Clinical Trial Site Shine: Tips and Strategies
Munaza Jamil, BSc, CCRA, CCRP, Clinical Research Professional/Instructor, UC Berkeley
Aside from patients, there is no greater resource than sites themselves for running a successful clinical trial. What factors do Sponsors consider when selecting sites? Do “preferred site” lists really exist? This presentation will discuss best practices and benefits of keeping your site in top shape, and outline key strategies that will make your site stand out.
4:15-4:30 Conference Wrap up and Q&A