Multi-Regional Clinical Trials Center (MRCT Center)

Submitted by Maxine Harney on Wed, 06/19/2019 - 2:52pm

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WELCOME TO THE MRCT CENTER VIRTUAL TRAINING

The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center) is a research and policy center dedicated to promoting safe and ethical clinical trials, with a particular focus on multi-site, multi-national trials. The MRCT Center brings together collaborative, multi-disciplinary stakeholders from industry, academia, patient advocacy groups, non-profit organizations, and regulatory agencies to define emerging issues in global clinical trials and to create and implement ethical, actionable, and practical solutions.

Training is one of the core strengths of the MRCT Center and we use complementary approaches of online, in person, and in-country training resources. We are committed to building capacity for clinical research personnel, research ethics boards, regulators, patients, the public, and others to help ensure the ethical conduct of research and research integrity.

Ethics & Review of Interventional Clinical Research
	This course was developed in partnership with the World Health Organization and aims to meet the growing demand for a training on the scientific and ethical aspects of interventional clinical trials. This course is tailored to research ethics committee members, chairs, administrative staff, and others who review clinical trial protocols. It will also benefit regulators, investigators, study staff, care providers, and others involved in clinical trials. This course is available free of charge worldwide. VIEW COURSE
An Introduction to ICH E8(R1) - General Considerations for Clinical Studies
	This is an introductory video for the ICH E8(R1) Guideline - General Considerations for Clinical Studies. Posted on the International Council for Harmonisation of Techincal Requirements for Pharmaceuticals for Human Use (ICH) website, the MRCT Center developed this introductory video to provide an overview of the general principles in clinical research & quality by design. To view the video, click here.
DIVERSITY AND INCLUSION: EQUITY BY DESIGN
	This six-part virtual training focuses on practical approaches to address diversity, equity, and inclusion (DEI) of underrepresented populations in clinical research. The course is intended to aid cancer centers in improving their ability to enroll and retain underrepresented participants in clinical research. Further, the course highlights responsibility, accountability, and sustainability for DEI in clinical research. VIEW COURSE
INTERPRETATION AND APPLICATION OF ICH E6(R2)
	This is an introductory course consisting of 10 modules that reflects the ICH Guideline E6(R2): Guideline for Good Clinical Practice. The content is particularly directed at governmental regulatory reviewers and inspectors and is also applicable to other stakeholders including investigators, study teams, ethics committee members, research organizations, and sponsors. VIEW COURSE (View Chinese modules, here)
ESSENTIAL ELEMENTS OF ETHICS
	This is an introductory course consisting of 11 modules that will assist (1) clinical researchers as they write their study protocol to recognize and address common ethical challenges in clinical trials, and (2) ethics committee members as they review and analyze clinical trial protocols in an efficient and comprehensive manner. VIEW COURSE
IRB HEALTH LITERACY TRAINING
	This is an introductory health literacy training developed specifically for Human Research Protection Programs (HRPPs) and Institutional Review Boards (IRBs). The course is intended to support IRB members and staff in learning about health literacy and reflecting on their roles in reviewing and approving clear, understandable participant-facing research communications. The training activities for individuals include a video, teach-back questions, and before-and-after exercises. VIEW COURSE
To access the modules, please click the links above for further information and instructions. For any questions, please contact Carmen Aldinger (caldinger@bwh.harvard.edu).