9:00-9:30 Registration and Continental Breakfast (provided)
9:30-10:00 Introduction and Welcome
Jennifer Li, BSc, CCRP, Quality Manager, Cancer Clinical Research Unit, Princess Margaret Cancer Centre / University Health Nework
Greg Staios, MSc, CCRP, Professor, Seneca College, School of Biological Sciences and Applied Chemistry, Clinical Research Program
10:00 - 10:45 Use of Investigational Products: Information and Implementation
Jeffrey Doi, HonBSc, BScPharm, RPh, BCPS, Clinical Trials Pharmacist, Princess Margaret Cancer Centre, UHN
Conducting a clinical trial involving an investigational product requires an understanding of the study drug itself and its use within the regulatory framework of Division 5. Mr. Doi will provide an overview of how to review Investigator Brochures, focusing on identifying potential risks to participants. In addition, he will present practical challenges and solutions in applying Division 5 requirements to the everyday use of investigational product in an Investigational Drug Services pharmacy.
10:45-11:00: Break
11:00 - 11:30 Innovation Showcase: Project Lifecycle - A REDCap-Based Project Tracker
Chris Battiston, BASc(Hons), Research Database Administrator, Women's College Hospital
Mr. Battiston will discuss how they developed a project management tool to assist small teams in managing REDCap-based projects and activities from the server operating systems up to user support and training. With an end goal of improving efficiency, the "Project Lifecycle" tool helps to better capture metrics, automate communication, and otherwise streamline the overall process. This presentation will be an overview of the project, including some fancy new functionality.
11:30 - 12:00 Innovation Showcase: Implementation of a monitoring education series to facilitate successful execution of monitoring plans and improved quality assurance for investigator initiated trials
Ivy Salter, BA, Clinical Research Coordinator, Ottawa Hospital Research Institute
Ms. Salter will discuss how their research team developed a monitoring education series to better educate research staff on all aspects of investigator initiated trial monitoring, as well as provide hands on tools to support their monitoring journey. The goal for this education series is to help improve quality assurance practices for investigator initiated trials and has built a network for those able to assist with peer to peer monitoring for research teams in need of this support. Learn about this initiative, its challenges and successes.
12:00-1:00: Lunch
1:00 – 3:00 Health Canada Regulatory Operations and Enforcement Branch (ROEB)
The Health Canada Regulatory Operations and Enforcement Branch (ROEB) will provide updates through a series of presentations related to the conduct of regulated clinical trials in Canada.
3:00 3:15 Break
3:15 - 4:00 Health Canada Special Assess Programme
Sophie Hamel, MSc, PhD, Senior Clinical Assessment Officer, Health Canada
Dr. Hamel will discuss Health Canada's Special Access Programme (SAP) and OLIP. The presentation will include an overview of the Clinical Trial Agreement (CTA) process and review any further updates on E6(R3) and/or regulatory modernization, especially DCTs and novel trial designs
4:00-4:45 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.
4:45-5:00 Day 1 Wrap up and Q&A
Join conference speakers and fellow attendees for the panel discussion each day. Take advantage of this opportunity to engage with the speakers and delve deeper into the topics of the day. The speakers will facilitate discussions and field participate questions.
9:15-9:30 Continental Breakfast (provided)
9:30 - 10:30 Quality in the Clinical Trial Ecosystem
Jean Smart, RAC, Regulatory Affairs & Quality Officer, Michael Smith Health Research BC - Clinical Trials BC
The ICH E6(R3) Good Clinical Practice builds on key concepts outlined in ICH E8(R1) General Considerations for Clinical Studies. There is heavy emphasis on quality in both documents including fostering a site quality culture by proactively designing quality into clinical trials conduct, identifying factors critical to trial quality, and engaging stakeholders while using a proportionate risk-based approach. This session emphasises the interconnectedness between E6R3 and E8R1 and the impact of quality expectations on site compliance and preparedness.
10:30-10:45 Break / Networking
10:45 - 11:15 Showcasse: Patient/Family Partner for Biobank Study Oversight Committee
Christine Kowal, MSc, CCRP, Research Coordinator, The Hospital for Sick Children
Ms. Kowel will discuss their initiative to engage patient/family partners to be part of the Neurodevelopmental Biobank for Advanced Research (NeuroBAR) Oversight Committee. NeuroBAR is a biobank study aimed to make brain tissue, cerebrospinal fluid (CSF), and blood samples available to researchers who are trying to better understand the causes of epilepsy and other neurodevelopmental conditions. Researchers wishing to obtain tissue, CSF, blood samples, and/or data from NeuroBAR for REB approved studies are invited to send an application to be reviewed by the NeuroBAR Oversight Committee.
11:15 - 11:45 Innovation Innovation Showcase: An Epic Reports Spotlight: Promoting Health Informatics at the Princess Margaret Cancer Clinical Research Unit to improve data extraction and transcription practices
Barbara Georgiades, BS, Clinical Trial & Regulatory Specialist II, Princess Margaret Cancer Center
Ms. Georgiades will discuss the implementation and deployment of Epic Reports course exploring five essential reports offered to all data coordinators via the EPIC Reporting Workbench tool: The Enrollment and Screening Report, the Appointments Report, the Adverse Events Report, the Concomitant Medications Report and the Consenting Worksheets Report. Learn how the optimization of data transcription through EPIC Reports contributes to more sustainable clinical research practices by improving a CRP’s time allocation and quality control measures.
11:45-12:45 Lunch (provided)
12:45 - 1:45 Act Like A Coordinator, Think Like An Inspector
Flora Noitsis, Hons. BSc, , Senior Associate, Quality & Compliance, BioAcuity Consulting, Inc.
Ms. Noitsis will conduct a interactive session by presenting 1 to 2 case studies to help participants identify quality deficiencies not in compliance with Health Canada Division 5 GCP regulations. Participants will be asked to role play as inspectors in mock inspection situations.
1:45 - 2:45 Data Management: The Data Management Plan (DMP)
Aisling Wynne, BSc, Senior Data Sciences Product Leader / Professor, Hoffman la Roche / Seneca College
Ms. Wynne will provide a summary of the Data Management Plan, why it’s required, and what it contains. This presentation will discuss how the DMP affects a Site User, CRA or other Clinical Research professionals. How can we work together to ensure good quality data for analysis.
2:45-3:00 Break
3:00 - 4:00 Clinical Trials Involving Psychedelics in the Advanced Cancer Population
Sarah Hales, MD, PhD, Psychiatrist, Clinician Investigator, Princess Margaret Cancer Centre, UHN
This talk will describe the psychedelic-assisted therapy paradigm and its components and discuss key findings from contemporary clinical trials in the cancer population. Dr. Hales will also review some of the unique ethical, regulatory, methodological, and practical challenges associated with this research.
4:00 - 5:00 Clinical Trial Monitoring in 2024: Essentials for the new (remote) “site owner”
Amr Sharaf, HBSc, CCRP, Senior Clinical Trial Monitor, Bristol-Myers Squibb
The role of the Clinical Research Associate is critical to the success of clinical trials. The evolution of this role is shifting from the historically mobile data-checker to the newly remote risk-manager. Some essential skills are discussed in order to be a successful CRA in this new dynamic.
5:00-5:15 Conference Wrap up and Q&A
Join conference speakers and fellow attendees for the panel discussion each day. Take advantage of this opportunity to engage with the speakers and delve deeper into the topics of the day. The speakers will facilitate discussions and field participate questions.