Program Description

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 for 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 opportunities and challenges facing the clinical research industry.
  • Discuss the challenges, opportunities, and best practices with Decentralized Clinical Trials.
  • Discuss the responsibilities of an investigator as outlined in ICH E6(R2) Guidelines Sections 4.1to 4.13.
  • Discuss regulation of investigational testing of medical devices in human in Canada, including limitations and key considerations.
  • Discuss the regulatory framework governing CTA and review process at Health Canada.
  • Discuss FDA’s role in the oversight of clinical trials that are conducted in Canada.
  • Discuss tools and resources researchers can access to learn more about best practices in RDM.
  • Discuss the sources of data and data itself that Data Management collects outside of the CRFs or EDC System.
  • Discuss how REDCap has been used Health Canada regulated clinical trials.
  • Discuss challenges and potential solutions for improving diverse clinical trials participation.
  • Discuss how to build a better site/sponsor relationship, with an emphasis on the monitor role.
  • Discuss how to best be prepared for a GCP inspection or audit.

 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.