9:00-9:30 Registration and Continental Breakfast (provided)
9:30-9:45 Introduction and Welcome
9:45-10:45: Opportunities and Challenges facing the Clinical Research Industry
Jennifer Li, BSc, CCRP, Quality Manager, Cancer Clinical Research Unit, Princess Margaret Cancer Centre / University Health Network
Greg Staios, MSc, CCRP, Professor, Seneca College, School of Biological Sciences and Applied Chemistry, Clinical Research Program
11:00-12:00 Decentralized Clinical Trials: CRAFT – Satellite Site Implementation
John Thoms MD, MSc, FRCPC, Associate Professor / Radiation Oncologist, Discipline of Oncology, Faculty of Medicine, Memorial University of Newfoundland
Dr. Thoms will provide an introduction to the Canadian Remote Access Framework for Clinical Trials (CRAFT), which helps enable clinical trial participation for patients who live far from the healthcare site where the trial is primarily offered. He will share from a satellite site's perspective on the implementation of such framework, and discuss the challenges, opportunities, and best practices with Decentralized Clinical Trials.
1:00-2:00 ICH E6 (R2): Good Clinical Practice
Jasmine Grant, MEd, HBSc, CCRP, Clinical Research Manager, Princess Margaret, University Health Network
This presentation will focus on the responsibilities of an investigator as outlined in ICH E6(R2) Guidelines Sections 4.1to 4.13. Sections reviewed will be: Qualifications, Task Delegation, Time and Resources, REB/IRB Communication, Informed Consent, Investigational Product, Protocol Adherence, Safety Reporting, and Documentation.
2:00 – 2:45: The Regulations of Medical Devices Investigational Testing in Canada
Tanya Ramsamy, PhD, Executive Director, Bureau of Investigational Testing, Special Access and Post-Market Surveillance, Health Canada
Dr. Ramsamy will provide an overview of the regulation of investigational testing of medical devices in human in Canada, including limitations and key considerations. The regulation of Covid-19 medical device clinical trials and the clinical trial modernization initiative will also be discussed.
2:45 -3:30: Clinical Trials Review Process at Health Canada
Jaigi Mathai, PhD, Manager of Clinical Trials Review Group 2, Office of Clinical Trials, Health Canada
This talk aims to provide an overview of the regulatory framework governing CTA; the CTA review process at Health Canada and to discuss issues that impede review process and solutions to ensure smooth approval for clinical trial authorization in Canada.
3:30 3:45 Break
3:45-4:30: FDA’s Bioresearch Monitoring Program - Foreign Inspections and Program Updates
CDR Gene Gunn, MSPH, Investigator (Bioresearch Monitoring Specialist), US Food and Drug Administration
CDR Gunn will focus on the FDA’s role in the oversight of clinical trials that are conducted in Canada. Special attention will be paid on what to expect during an FDA inspection.
4:30-5:00 Day 1 Wrap up and Q&A
9:15-9:30 Continental Breakfast (provided)
9:30-10:15: Advancing Research Data Management in Canada to Enhance Quality, Promote Transparency, and Maximize Impact
Michael A. Voth, MSc; ASQ, Manager, Research Quality Integration, University Health Network
Research Data Management (RDM) encompasses practices applied across the lifecycle of a research project to guide the collection, documentation, storage, sharing, and preservation of research data. RDM is getting a lot of attention from public funders and regulatory authorities who are advancing policies and expectations for sponsors and investigators to ensure security and quality of research data while maximizing its impact through data sharing and publically posting the results of research.
Mr. Voth will highlight evolving funder and regulatory requirements, focus on the key components of a project-specific data management plans, and identify tools and resources researchers can access to learn more about best practices in RDM.
10:15-10:45 Break / Networking
10:45-11:30: Data Management and Database Design/Testing
Aisling Wynne, BSc, Senior Data Sciences Product Leader / Professor, Hoffman la Roche / Seneca College
A review of the sources of data and data itself that Data Management collects outside of the CRFs or EDC System. How do we get it (transfers vs integration), what do we do with that data, and how does that affect a Site User, CRA or other Clinical Research professional. How can we work together to ensure good quality data for analysis.
11:30-12:30: A pragmatic approach to REDCap validation
Rick Watts, BSc, Team Lead, Data Coordinating Centre, Women & Children’s Health Research Institute, University of Alberta.
WCHRI has used REDCap in support of Health Canada regulated clinical trials since 2012 and maintains a validated installation for that purpose. This talk will discuss our journey with regard to validation, highlight some challenges and describe where we’re planning on going next.
12:30-1:30 Lunch (provided)
1:30-2:15 Enhancing diversity in Clinical Trials: Challenges and Solutions
Sarah Bridges, MAHSR, Research Coordinator Maritime SPOR SUPPORT Unit, Horizon Health Network
Munaza Jamil BSc, CCRA, CCRP, Program Lead, Quality Assurance and Monitoring, Maternal Infant Child Youth Research Network / McMaster University
This interactive presentation will allow the speakers to share experiences and viewpoints as we work towards building a more inclusive and diverse landscape for clinical trials in Canada. We will be discussing the challenges and potential solutions for improving diverse clinical trials participation; the importance of a diverse clinical research workforce; and how N2 is working to help meet the challenge of improving EDI in clinical research.
2:15-3:00: Building Better Site/Sponsor Relationships – A Monitors Perspective
Amr Sharaf, HBSc, CCRP, Senior Clinical Trial Monitor, Bristol-Myers Squibb
This talk will focus on how to build a better site/sponsor relationship, with an emphasis on the monitor role. The focus will be on seemingly minor changes in how you interact with your site/sponsor that can have a major impact on productivity, responsiveness and transparency in the conduct of your trial.
3:30-4:30: Preparing for a Clinical Trial Inspection or Audit
Flora Noitsis, Hons. BSc. Senior Associate Compliance & Regulatory, BioAcuity Consulting Inc.
Ms. Noitsis will discuss how to best be prepared for a GCP inspection or audit. The presentation will focus and highlight best practices to be implemented including behavior Do’s and Don’t’s.
4:30-5:00 Conference Wrap up and Q&A