Conducting Clinical Trials in Canada: Canadian Regulatory Virtual Conference
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 how remote monitoring became the new norm and the potential impact on monitoring in the future.
- Discuss REDCap surveys, data management functions, and product design best practices.
- Discuss and review of the sources of data and data itself that Data Management collects outside of the CRFs or EDC System.
- Discuss 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.
- Discuss the relationship between FACT and research regulations, with a focus on the in the Canadian context.
- Discuss how to be GCP inspection ready to be compliant with Canadian legislation.
- Discuss responsibilities of an investigator as outlined in ICH E6(R2) Guidelines Sections 4.1 to 4.13.
- Discuss Decentralized Clinical Trials (DCTs) limitations and challenges associated with this type of trials.
- Discuss regulatory changes made recently for medical devices and clinical research
- Discuss the current clinical trial landscape in Canada, current regulations and how Canada is proposing to modernize its clinical trial regulatory framework.
- Discuss the proposed changes of modernizing Health Canada’s Clinical Trial Regulations.
- Discuss FDA’s role in the oversight of clinical trials that are conducted in Canada.
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.