*All times in Eastern Time Zone
1:00 – 2:00pm: A Sponsors Perspective on Remote Monitoring
Amr Sharaf, HBSc, Senior Clinical Trial Monitor, Bristol-Myers Squibb
Monitoring practices have changed drastically over the past few years, namely due the ongoing pandemic. The implementation of remote monitoring has gone from a futuristic goal for many to a new norm incredibly quickly, but not without hiccups. Mr. Sharaf will explore how remote monitoring became the new norm and the potential impact on monitoring in the future.
2:00 - 3:00pm: REDCap 101
Steve Hawley, MSc. EMHI, Clinical Data Manager/Analyst, Verily
Mr. Hawley will provide a high-level tour of the REDCap EDC system. Highlights will include the Online Designer, REDCap surveys, and data management functions, as well as project design best practices. We’ll also go beyond the software to look at the international community of REDCap partners that make the platform truly unique, the REDCap Consortium.
3:00- 3:30pm: Break
3:30 - 4:30pm: Data Management and handling of Non-CRF or Vendor Data
Aisling Wynne BSc, Senior Data Sciences Product Leader, Hoffman la Roche and Professor, 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.
1:00-2:00pm: Integrate Eight – The Implementation of E8R1 and Quality into Sites
Jean Smart, RAC, Regulatory Affairs & Quality Officer, Michael Smith Health Research BC – Clinical Trials BC
The new ICH E8R1 guidance presents us with an updated quality content essential for all clinical trials. This session covers the challenges, planning, impact and necessary resources related to the integration of quality components into a site/program involved in the conduct phase of quality by design.
2:15 – 3:15pm: FACT Standards and the Canadian Clinical Trials Regulatory Landscape
Ekaterina Hult, MSc, CCRP, Research Quality Specialist, Princess Margaret Cancer Centre, University Health Network
The main objective of the Foundation for the Accreditation of Cellular Therapy (FACT) Standards for immune effector cells (IEC) is to promote quality practices and ensure patient safety. Ms. Hult will review the relationship between FACT and research regulations, with a focus on the in the Canadian context. She will discuss her site’s experience integrating research into an accredited clinical program.
3:15-4:15pm: GCP Inspection Readiness for Canadian Compliance
Flora Noitsis, Hons. BSc, Senior Associate, Quality & Compliance, BioAcuity Consulting, Inc.
Ms. Noitsis will focus on being GCP inspection ready to be compliant with Canadian legislation. She will focus on best tips and practices as well as what should be avoided.
4:15 - 5:00pm: Virtual Networking Event
1:00 – 2:15pm: ICH E6 (R2): Good Clinical Practice
Jasmine Grant, BHSc, M.Ed, Lead, Research Training Program, Princess Margaret Cancer Centre, University Health Network
This presentation will focus on the responsibilities of an investigator as outlined in ICH E6(R2) Guidelines Sections 4.1 to 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.
2:15-2:45pm - Break
2:45 - 3:45pm: Liability, IP and Data Issues — A True Investigator-Initiated CTA Case Study
Marlon Rajakaruna, BA, LLB, MBA, CRCP, Lawyer, Kingsgate Legal
The speaker will share his experience working as legal counsel on an international, multi-center, investigator-initiated clinical trial sponsored by a Canadian site. Mr. Rajakaruna will review contract challenges and examples of potential unfavorable outcomes. In addition, he will discuss options for resolution of issues and opportunities for improvement while also sharing lessons learned and practice tips.
3:45 - 4:45pm: Lessons Learned from conducting a Decentralized Clinical Trial: You Don’t Know Until You Know
Rosemarie Clarke, RN, MHM, CCRP, Clinical Research Manager, University Health Network/Toronto General Hospital
Ms. Clarke will discuss Decentralized Clinical Trials (DCTs) limitations and challenges associated with this type of trials. She will also provide best Practices when conducting DCTs.
1:00-1:45pm: Investigational Testing – Medical Device Clinical Trials
Julie Taing, BSN, RN, Regulatory Affairs Supervisor, Health Canada
A presentation about the Medical Device Directorate’s Investigational Testing Division, intended to provide regulatory guidance on the organization and submission of an Investigational Testing Authorization application to conduct investigational testing of a Class II, III or IV device, by the manufacturer, an academic institution, a health care facility or a contract research organization.
1:45-2:30pm: Health Canada Trial Compliance Program
Hocine Abid, MD, National Manager, Clinical Trial Compliance Program, Health Canada
Dr. Abid will review the current clinical trial landscape in Canada, current regulations and how Canada is proposing to modernize its clinical trial regulatory framework.
2:30-3:15pm: Modernizing Clinical Trial Regulations
Larissa Lefebvre, BSc, Manager, Sumission Management Division, Health Canada
Ms. Lefebvre will focus on the proposed changes of modernizing Health Canada’s Clinical Trial Regulations. A consultation paper was published and stakeholders were asked to provide comments. A high level summary of the responses will be presented.
3:15 – 3:30pm: Break
3:30-4:15pm: 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.
4:15-5:00pm: Regulatory Body Panel/Q&A