Conducting Clinical Trials in Canada
A Uniquely Canadian Perspective For all Clinical Research Professionals
Goal: The Society of Clinical Research Associates (SOCRA) recognizes the continuing need for education for Clinical Research Professionals responsible for the activities at the research site or institution. 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 on Harmonisation (ICH) guidelines as well as practical procedures and site / sponsor / CRO relationships.
Learning Objectives: Upon completion of the conference, 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
In addition to lecture and discussion regarding research in Canada, this conference includes training that meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.