Click here to view the Annual Meeting Slides (for sponsors only).
The principal topics discussed at the MRCT Center 2018 Annual Meeting were:
European Union General Data Protection Regulation (GDPR)
Representation of Diverse Populations
Advancing the Study of Clinical Trials
Capacity Building
Health Literacy in Clinical Research.
The meeting was followed by the Executive and Steering Committee meeting in the afternoon (1:00 PM -5:00 PM), which was open to MRCT Center sponsors only.
The MRCT Center will be facilitating didactic and case-based learning, presentations, and open discussion for regulators from Health Canada (reviewers and inspectors), and individuals from industry, academia, and non-profit organizations
Learning Objectives:
Describe the standards of Good Clinical Practice (GCP) and key considerations in Multi-Regional Clinical Trials (MRCTs) design as set out in ICH E6(R2) and ICH E17 guidance, with particular focus on how the guidelines are applied by Health Canada.
Use case studies, to apply the changes of ICH E6(R2) addendum and ICH E17 to increase the acceptability of MRCT data by multiple regulatory authorities
Demonstrate practical approaches that Health Canada may take to fulfill the requirements of ICH E6(R2) and ICH E17 consistent with ICH standards
For Regulators:
Describe and demonstrate best practices to assess clinical trial regulatory submissions by Health Canada, including study design, data packages, essential documents, reports, and filings for alignment with ICH GCP and MRCT
Describe inspection methodologies that may be taken by Health Canada to assess clinical trial conduct for alignment with ICH GCP and MRCT standards, including review of corrective actions.
For other Stakeholders:
Gain better understanding and knowledge of Health Canada expectation with regard to compliance with the Canadian clinical trial regulations.
Gain better understanding and knowledge of Health Canada GCP inspection processes to better prepare for an inspection
Joint Task Force for Clinical Trial Competency Project-Specific Website
Explore our project-specific website, that defines the knowledge, skills and attitudes necessary for conducting safe, ethical and high-quality clinical research.
The Joint Task Force for Clinical Trial Competency (JTF) is an international team of investigators, educators and clinical research professionals that has developed a framework that defines the knowledge, skills and attitudes necessary for conducting safe, ethical and high-quality clinical research.
The MRCT Center initially co-led an effort in 2013 to convene a group of diverse stakeholders to align and harmonize core competencies for clinical research professionals into a single, high-level set of standards that could be adopted globally and serve as a framework for defining professional competency throughout the clinical research enterprise. Since the Harmonized Core Competency Framework was released in 2014, clinical trial researchers and training organizations have been able to rely on a single set of harmonized competencies for training and qualification purposes. Institutions around the world have utilized and applied the Framework to develop job descriptions, training modules, and other resources. The MRCT Center continues to lead the Joint Task Force for Clinical Trials Competency to adapt and evolve the Framework to meet the needs of its stakeholders globally.
Continuously assess and evolve the JTF Core Competency Framework for Clinical Research Professionals to meet the needs of clinical researchers globally
Develop additional resources to aid in the professional development of clinical researchers
June-November 2020: Conducted Self-Assessment Survey of Clinical Research Competency
February 2020:Launched Version 3.1 of Core Competency Framework, including changes from Clinical Project Management Workgroup
January 2020: Published the Japanese translation of the Core Competency Framework
February 2019: Launched new Joint Task Force for Clinical Trial Competency project website and launched workgroup for Clinical Project Management (CPM)
November 2016: Initiated 2 new workgroups in the wake of the workshop: The Revisions Workgroup, constituted to update the Harmonized Core Competency Framework based on suggestions from implementers and stakeholders; and The Levelling Workgroup, to define and stratify competencies at fundamental, skilled, and advanced levels.
October 2016: Convened Joint Task Force Core Competencies Workshop to discuss real world applications and potential future revisions of competency framework
March 2013: Convened first meeting of stakeholder groups including industry, academia, clinical research organizations, clinical sites, and professional societies; the group was termed the Joint Task Force for Clinical Trial Competency
project leadership & Staff
Barbara E. Bierer, MD, Faculty Director, MRCT Center, Co-Chair, Joint Task Force for Clinical Trial Competency
Stephen Sonstein, PhD. Co-Chair, Joint Task Force for Clinical Trial Competency
In October 2022, the MRCT Center delivered four modules as part of a virtual training to provide advanced learning for public and private university lecturers who teach in undergraduate and graduate biotechnology degree programs in Indonesia. The training focused on real world data, genomics, and research ethics to capacitate and advance the field of biotechnology at the university and graduate level. Guest speakers also inspired the 25 training participants by sharing their personal experience in the related fields and engaging in an interactive “Ask the Experts” session. The training was part of the 2022 Association of Indonesia’s Biotechnology Study (IPSBI) Programs, organized and supported by Pfizer Indonesia.
