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.
The skills and experience of investigators and study staff, research ethics boards, and regulators vary widely across the globe. To meet the demands of the changing regulatory and ethics landscape, regulators, ethics committees, Investigators, and site staff need continuous learning and discussion of emerging issues in clinical research. Training and capacity building is one of the core strengths of the MRCT Center.
Long-standing history in capacity building
The MRCT Center has a long-standing history of developing ethics and regulatory skills in both high and low- and middle-income countries. The MRCT Center has been endorsed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) as a training associate and designated as an Asia-Pacific Economic Cooperation (APEC) Training Center of Excellence. Over the past decade, our capacity building efforts have trained more than 10,000 participants from over 100 countries and spanned from data monitoring committees, pharmacovigilance and safety, clinical research professional competency, good clinical practice and multi-regional clinical trials, to research ethics.
Approach to capacity building and training
Since 2020, the MRCT Center has leveraged technical capabilities to develop both virtual and sustainable online training.
In-person or in-country training: in-person / in-country dynamic training using a training model in which we partner with a local collaborator (e.g., academic leader, regulator, institution) to identify the appropriate topics that are of highest need and select the trainees for the course
Online, recorded training modules: available free of charge on an MRCT Center portal within the Mass General Brigham Office of Continuing Professional Development website.
Virtual training: live, interactive training sessions delivered virtually, in collaboration with an in-country partner
The MRCT Center has expertise in the following areas:
ICH Guidelines: As a Training Associate of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the MRCT Center is working with ICH to develop a series of training modules:
General Considerations for Clinical Trials E8(R1): The E8(R1) Introductory Overview Video is available on the ICH Training Library website. A series of in-depth training modules for ICH E8(R1) with case studies and interactive learning activities is in development.
Good Clinical Practice E6(R3): The MRCT Center is working closely with the E6(R3) Expert Working Group (EWG) to develop a series of in-depth training modules for the revised Good Clinical Practice (GCP) guidelines. The first set of modules will be released in mid-2025.
General Principles for Planning and Design of Multi-Regional Clinical Trials E17: A landscape analysis of implementation issues with ICH E17 is in development.
Clinical Research and Ethics: The MRCT Center is building capacity for research ethics committees (RECs) across Africa and worldwide. Our work aims to harmonize the clinical trial application review process and build a robust, competent, and efficient system for the ethics review of clinical research. The online, on-demand training course entitled “Ethics and Review of Interventional Clinical Research” is freely available on the WHO Academy. Development for the second course in the series “Ethics and Review of Interventional Clinical Research” is ongoing and anticipated to be available in the fall of 2025.
Clinical Research Design and Conduct: The MRCT Center designed a curriculum to introduce the audience to the process of drug development and clinical research, including research and development, bioethics, good clinical practice, regulatory requirements, as well as post-market surveillance and real-world evidence. The MRCT Center collaborates with partners to design the curriculum specific to the audience as well as the local regional context. Example: Virtual clinical research training in Indonesia.
Data Monitoring Committee Training: Recognizing the need for greater engagement from emerging economies, the MRCT Center created a training program to engage motivated individuals to become Data Monitoring Committee (DMC) champions within their home country and to participate in DMCs for multi-regional clinical trials. Example: Virtual DSMC Training in the Philippines.
Health Literacy: Online, virtual, and in-person capacity building activities provide research professionals with practical guidance and tools to integrate health literacy best practices into their roles. For Example: IRB Health Literacy in Clinical Research online training.
Representation in Clinical Research: The MRCT Center training is intended to aid attendees in improving their ability to enroll underrepresented participants in clinical research and develop mechanisms for ongoing sustainability of representative populations in clinical research. For more information: Equity by Design 6-part virtual training course.
Causality Training: This training enables clinicians and ethics committee members to follow best practice procedures in determining causality for participant injuries or illnesses occurring in the course of a clinical trial. Example: Causality Assessment Workshop in Gurgeon, India.
OBJECTIVES
Improve regulatory capacity to provide a unified standard for conducting and oversight of clinical trials
Improve capacity of those planning and reviewing clinical trials to conduct effective multi-regional trials
Improve capacity of those planning, reviewing, and conducting clinical trials to ultimately lead to participant safety
project Leadership & sTAFF
Barbara Bierer, MD. Faculty Director, MRCT Center
Sarah White, MPH. Executive Director, MRCT Center
Carmen Aldinger, PhD, MPH, PMP. Senior Administrative and Training Manager, MRCT Center
Chloe de Campos, BS. Graphics and Information Design Specialist, MRCT Center
Lauren Otterman, MBE. Project Manager, MRCT Center
