Focus Area: Capacity Building

TRAINING MODULES

Training & Education

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

Areas of Expertise:

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.

Project Resources