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Training

Training

Training

Context

Human research participants, the public, sponsors and funders need assurance that clinical trials are ethical and overseen and regulated by experienced and competent professionals and at qualified sites that have the necessary resources to ensure human research protections.

Challenge

Worldwide, the skills and experience of investigators and study staff, research ethics boards, regulators, coordinators, and data monitoring committees vary widely. Appropriate training and support for clinical research personnel, research ethics boards, regulators and others can help ensure the ethical conduct of research and research integrity.

MRCT Center Training Projects

Training is one of the core strengths of the MRCT Center.  Complementary approaches are employed:

1) We conduct in-country, in-person 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, to select the trainees for the course, and to arrange the on-site location.

2) We conduct trainings at Brigham and Women’s Hospital and Harvard, inviting key international leaders and regulators for on-site training.

3) We create on-line training resources and develop eLearning courses.

Attendees of our trainings have included regulators, investigators, site staff, local industry and ethics committee members.

Training Sessions

Examples of past international trainings, in collaboration with local partners, have included:

Training Sessions

DateLocationPartnerTopic(s)No. Trained
May 2013Boston, USSociety of Clinical TrialsDMC30
Oct 2013Daegu, KoreaDaegu Catholic University Medical CenterDMC70
Jan 2014Bangalore, IndiaISCRDMC50
April 2014Tokyo, JapanJPMADMC150
May 2014Shanghai, ChinaDIADMC20
Nov 2014Gurgeon, IndiaBiogenCausality training35
Jan 2015Bangkok, ThailandHIV-NATDMC62
Feb 2015Delhi, IndiaIndian Society of Clinical ResearchCausality training60
Oct 2015Beijing, ChinaPeking U.ICH/GCP MRCTs30
Nov 2015Johannesburg &
Cape Town, South Africa
Univ. of Witwatersrand & Univ. of Cape Town
Global Health Network
Causality Training Pharmacovigilance Vaccine development100
April 2016Sao Paolo, BrazilSociedade Brasileira de
Medicina Farmacêutica, Lilly
MRCT Post-trial responsibilities40
Sept 2016New Haven, USAYale, Novartis, CFDAMRCTs30
Oct 2017Cambridge, USAInternational Council for Harmonisation (ICH)ICH Good Clinical Practice (GCP)25

Current projects in this area include:

MRCT Training Assets (in alphabetical order)

Causality Training
Assignment of causality of adverse drug reactions during a clinical trial is performed routinely to determine the relationship of a safety event to use of an investigational product. Safety assessments of an investigational product depend upon understanding of causality.  Furthermore, Indian regulations directly link trial participant compensation for injury or death to causality assessment.  Fair compensation for injury occurring 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. Read more

Clinical Research Professional Competency Framework
The MRCT Center convened 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.   Read more

Data Monitoring Committee Training
Countries in which global trials are conducted are often underrepresented in the Data Monitoring Committees (DMCs) that oversee safety for these trials. Recognizing the need for more engagement from emerging economies, the MRCT Center developed a training program to promote diverse participation in DMCs for multi-regional clinical trials. Read more

Good Clinical Practice (GCP) Training

APEC Pilot Center of Excellence
The MRCT Center is an Asia-Pacific Economic Cooperation (APEC) Pilot Center of Excellence (CoE) for Multi-Regional Clinical Trials (MRCTs) and Good Clinical Practice (GCP) inspections, aiming to train regulators from APEC economies. Read more

ICH/GCP Training
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) has recently endorsed a training effort to help ensure greater adoption of ICH guidelines by regulators and industry. The MRCT Center was selected to conduct training on ICH E6 and E6 (R2). Read more

Multi-Regional Clinical Trials
We focus on challenging aspects of training for MRCT implementation, including providing scientific justification to support the utilization of an MRCT to demonstrate sufficiency for safety and efficacy determinations in a particular population.  We are developing training resources for ICH E17 to pilot in early 2018.