CAPACITY BUILDING
Our Work

Training & Education

TRAINING MODULES
MRCT Center Virtual Training

View all MRCT Center virtual training modules here:

Training & Education

Global Capacity Building

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. Our objective is to develop and deliver curricula to inspire students and improve the clinical research process.

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-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 5,000 participants from over 90 countries and spanned from data monitoring committees, pharmacovigilance and safety, clinical research professional competency, good clinical practice and MRCTs, 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 trainings.

  • 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
  • In-person or in-country training: in-person / in-country dynamic trainings 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

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
  • Samjhana Bogati, BSN, RN. Program Manager
  • Lauren Otterman, MBE. Project Manager, MRCT Center

Training Sessions

Please click on the topics below to get information on the related training sessions

Causality Training

Safety assessments of an investigational product depends upon understanding of causality and the differentiation from correlation or association. Assignment of causality of adverse drug reactions during a clinical trial is predicated on an accurate causality assessment and determination of whether the injury or death is related to participation in the trial and a consequence of the investigational product. 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.

DateTrainingTraining Type
NOV 2015Data Monitoring Committees, Pharmacovigilance and Vaccine Development

U. of Witwatersrand & U. of Cape TownGlobal Health Network
In-country Training
Johannesburg & Cape Town, South Africa
FEB 2015Best Practices for Determining Causality Assessment for Adverse Events Occurring During Clinical Trial Participation

Indian Society of Clinical Research
In-country Training
Delhi, India

Details
NOV 2014Causality Assessment Workshop for Clinical Trial Investigators

Biogen
In-country Training
Gurgeon, India

Details

Clinical Research Design and Conduct

The curriculum is designed 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.

DateTrainingTraining Type
OCT 2022Pfizer Biotech Program: Training for public and private university lecturers

Pfizer Indonesia
Virtual training

Details
OCT 2021Pfizer Biotech Fellowship Program: Higher Height

Pfizer Indonesia
Virtual training

Details
MAY/JUN 2021B-Imtiyaz, a program to supplement university education for pharmaceutical and bioengineering majors through lectures given by international experts

Pfizer Algeria
Virtual training

Details

Data Monitoring Committee Training

Countries in which global clinical trials are conducted are often underrepresented in the Data Monitoring Committees (DMCs) that oversee these trials. Recognizing the need for greater engagement from emerging economies, the MRCT Center created a training program in 2012 aiming to engage motivated individuals to become DMC champions within their home country and to participate in DMCs for multi-regional clinical trials.

DateTrainingTraining Type
JUL 2022Data Safety Monitoring Committee (DSMC) training

National Institutes of Health at the University of the Philippines in Manila, Philippines
Virtual training
Manila, Philippines

Details
JAN 2015Data Safety Monitoring Board (DSMB) Training

HIV-NAT
In-country training
Bangkok, Thailand

Details
MAY 2014Data Safety Monitoring Board (DSMB) Pre-Conference DIA Workshop

DIA
In-country training
Shanghai, China
APR 2014Japan Data Safety Monitoring Board (DSMB) Training

JPMA
In-country training
Tokyo, Japan
JAN 2014Data Monitoring Committee / Data Safety Monitoring Committee (DMC/DSMB) training course

ISCR
In-country training
Bangalore, India
OCT 2013Data Safety Monitoring Board (DSMB) Workshop

Daegu Catholic University Medical Center
In-country training
Daegu, South Korea
MAY 2013“So you’ve said ‘yes’ Now What? Sitting on or Chairing a Data Safety Monitoring Board” and “Data Safety Monitoring Boards for Multi-Regional Clinical Trials”

Society of Clinical Trials
In-person training
Boston, US

Details

Diversity, Equity and Inclusion (DEI) in Clinical Research

The participant population enrolled in clinical trials ideally reflects the composition of the general population or of those affected by the disease, so that the research yields generalizable knowledge pertinent to the population that will use the product. 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 DEI in clinical research.

DateTrainingTraining Type
MAR/APR 2022Equity by Design, a virtual training course communicating an understanding of, and training on best practices for, diversity, equity, and inclusion (DEI) of underrepresented populations in clinical trials, focusing on cancer trials.

Center for Cancer Equity and Engagement at the Dana-Farber/Harvard Cancer Center (DFHCC)
Virtual training and online training

Details

GCP and MRCT

Consistent with the goals of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), regulatory authorities worldwide wish to ensure that drugs, biologics and devices are developed by processes that uphold the highest ethical standards and scientific principles. The MRCT Center has been designated as an ICH Associate and as an Asia-Pacific Economic Cooperation (APEC) Training Center of Excellence in the area of Multi-Regional Clinical Trials and Good Clinical Practice (GCP) and offers onsite, in-country and online training on this topic.

DateTrainingTraining Type
Since FEB 2020Interpretation and Application of ICH E6(R2)

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
Online training

Details
FEB 2019ICH E6(R2) Good Clinical Practice and ICH E17 Multi-Regional Clinical Trials Training

Health Canada
In-country training
Ottawa, Canada

Details
APR 2018APEC Pilot Center of Excellence Training on Multi-Regional Clinical Trials (MRCT) and Good Clinical Practice (GCP)

Asia-Pacific Economic Cooperation (APEC) Harmonization Center (AHC)
In-person training
Cambridge, USA

Details
OCT 2017ICH E6(R2) GCP Pilot Training

International Council for Harmonisation (ICH)
In-person training
Cambridge, USA

Details
SEPT 2016Multi-Regional Clinical Trials (MRCTs): Practice and Issues of Multi-Regional Clinical Trials’ Global Acceptance

Yale, Novartis, CFDA
In-person training
New Haven, USA
OCT 2015Regulatory and Scientific Workshop

Peking U.
In-country training
Beijing, China

Details

Health Literacy

Since 2018, the MRCT Center has focused on the importance of clear communication through the development of health literacy resources as part of the MRCT Center’s Health Literacy in Clinical Research Program. Online, virtual and in person capacity building activities that provide research professionals with practical guidance and tools to integrate health literacy best practices into their roles are available.

DateTrainingTraining Type
APR 2022Health Literacy for Human Research Protections Programs and Institutional Review Boards

Mass General Brigham Office of Continuing Professional Development
Online training

Details
FEB – APR 2021Applying Health Literacy Principles to Clinical Research Studies: A Three-part Health Literacy Training (Health Literacy 101, Health Literacy in Action, Health Literacy and Returning Research Results)

University of Utah
Virtual training

Details
OCT 2020Disseminating Research Results to Participants and the Public: Integrating Health Literacy Best Practices into Clinical Research Processes

Tufts Clinical and Translational Sciences Institute
Virtual training
APR 2019Plain Language for Health – Writing and Design Workshop for Health Research

Tufts Clinical and Translational Sciences Institute
Onsite training
Boston MA

Post-Trial Responsibilities

Post-trial responsibilities refer to a wide range of possibilities for providing continued access to study interventions (and potentially other care) once a trial is over, or a participant’s time on the trial has completed. The MRCT Center has provided training to clarify terms and interpretations related to “post-trial responsibilities” and to suggest standards with regard to the practical application of those directives.

DateTrainingTraining Type
APR 2016Post-Trial Responsibilities to Research Participants

Sociedade Brasileira de Medicina Farmacêutica, Lilly
In-country training
Sao Paolo, Brazil

Research Ethics

“Research Ethics” refers to addressing ethical issues in the design of clinical trials and documenting their rationale in a section of the study protocol. The MRCT Center collaborates with partners to design the curriculum specific to the audience as well as the local/regional Ethics Committee context.
The MRCT Center offers an online course that guides the development of a dedicated “Ethics section” of the protocol and offers virtual training of ethics committees and those reviewing clinical research applications, with a focus on Africa.

DateTraining Training Type
MAR-APR 2022Training for Ethics Review of Clinical Research: A Virtual Training Course for Africa

World Health Organization &
African Vaccine Regulatory Forum (AVAREF)
Virtual Training

Details
SEPT 2021Training for Ethics Review of Clinical Research: A Virtual Training Course for Africa

World Health Organization &
African Vaccine Regulatory Forum (AVAREF)
Virtual Training

Details
Since NOV 2014Essential Elements of Ethics

The Global Health Network
Online Training

Details