February 2024 SOCRA Source Journal - Journal - Page 96
SOCRA Conducting Clinical Trials in Canada
Conference
JULY 20 & 21, 2023 | TORONTO, ON
Conference Registration Fees:
Member (Canadian Resident): $525 USD Non-member (Canadian Resident): $600 USD
SOCRA Member: $670 USD
Non-member: $745 USD
*Non-member fee includes membership for one year
Health Canada Employees - Fee Waived (Must use Health Canada email to register)
Goal: The purpose of this workshop is to assist Research Professionals in improving their skills and their
understanding of the responsibilities of conducting clinical research in Canada.
Objective: The goal will be accomplished through lecture and practical application facilitated by clinical research
professionals. Information will be presented and discussed regarding the administration of clinical trials according
to Health Canada Regulations and International Council for Harmonisation (ICH) guidelines as well as practical
procedures and site / sponsor / CRO relationships.
Learning Objectives: Upon completion of this (full) course the attendee should be able to:
• Discuss current trends in clinical research and identify how these trends are influencing clinical development in
Canada.
• Discuss the benefits of Human Research Protections Accreditation
• Discuss how clinical research on cannabis represents unique challenges in Canada
• Discuss Health Canada common inspection findings, compliance trends, and program updates
• Discuss single REB review for multi-centre research
• Discuss affect of Canadian privacy legislation on clinical trials
• Discuss the proper administration of Phase IV trials in Canada
• Discuss the challenges of conducting investigator-initiated clinical trials
• Discuss the initiatives of the Network of Networks (N2)
• Discuss the core principles of ICH/GCP
• Discuss the Tri-Council Policy Statement and what it really covers
• Discuss best practices to mitigate the top 10 risks-related issues in Clinical Trial Agreements (CTA)
• Discuss implications of the Controlled Drugs and Substances Act.
• Discuss recent ICH E6 (R2) updates
• Discuss strategies for creating successful research sites
SOCRA designates this educational activity for a maximum of 12.75 Continuing Education Credits for SOCRA
CE and Nurse CNE.
SOCRA designates this live activity for a maximum of 12.75 AMA PRA Category 1 Credit(s)™. Physicians should
claim only the credit commensurate with the extent of their participation in the activity.
CME for Physicians: The Society of Clinical Research Associates is accredited by the Accreditation Council for
Continuing Medical Education to provide continuing medical education for physicians.
CNE for Nurses: Society of Clinical Research Associates is accredited as a provider of continuing nursing education
by the American Nurses Credentialing Center's Commission on Accreditation.
SOCRA Course Series: 450
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SOCRA SOURCE © May 2023