MRCT Center Resources

Resources

MRCT resources are sorted by Projects. Resources include public comments, presentations, proceedings, articles and publications, reports and guidance documents, templates, and training materials.  Please select a project below to see the full list of available resources.

For Resources that are available to sponsors only, please login on sponsor page.

The opinions contained therein are those of the authors and are not intended to represent the position of Brigham and Women’s Hospital or Harvard.

Transparency

Academic Credit for Data Sharing

Academic Credit for Data Sharing

Developing criteria and systems for recognition of generators of data in a way that is meaningful, appropriate, standardized, and accepted by researchers, academic institutions, journals, and funders

Transparency

Balancing Data Anonymization with Data Utility

Balancing Data Anonymization with Data Utility

Defining key principles of data protection and anonymization and working towards international harmonization of standards to enable clinical data sharing

Current Project

Ethics, Conduct, and Oversight

Bioethics Collaborative

Bioethics Collaborative

A forum to encourage the discussion of bioethical issues among stakeholders in global clinical trials for drug and device development

Capacity Building

Causality training

Causality training

Providing training to ensure those tasked with adjudicating causality are up-to-date on latest methods in causality determination and have practical scenarios.

Global Regulatory Engagement

China Global Regulatory Program

China Global Regulatory Program

Providing scientific justification for when the utilization of a multi-regional clinical trial is sufficient to demonstrate safety and efficacy in a particular population.

Capacity Building

Current Project

Clinical Research Professional Competency

Clinical Research Professional Competency

Promoting a set of harmonized competencies for training and qualification purposes of clinical research professionals.

Capacity Building

Data monitoring committees

Data monitoring committees

Identifying, recruiting and training leaders from emerging regions who have expertise in medicine or statistics and experience in clinical trials, to equip them to serve on Data Monitoring Committees (DMCs).

Transparency

Data Sharing in Informed Consent

Data Sharing in Informed Consent

Disseminating templates for informed consent forms and data use agreement for broad data sharing purposes to use prospectively.

Capacity Building

Current Project

Good Clinical Practice (GCP) and Multi-Regional Clinical Trials (MRCT) Training

Good Clinical Practice (GCP) and Multi-Regional Clinical Trials (MRCT) Training

Improving regulatory capacity to provide a unified standard for conducting clinical trials.

Current Project

Transparency

Harmonized Governance Tools for Data Sharing

Harmonized Governance Tools for Data Sharing

Developing harmonized governance tools for data sharing, enhance data transparency and collaboration, reduce administrative barriers, shorten the time to new discovery

Current Project

Ethics, Conduct, and Oversight

Health Literacy in Clinical Research

Health Literacy in Clinical Research

A collaborative project to support the development of tools and resources that more fully incorporate health literacy concepts into clinical research materials created for participants.

Current Project

Ethics, Conduct, and Oversight

Impact of GDPR on Clinical Research

Impact of GDPR on Clinical Research

An effort to understand the key issues and implications of the GDPR on multi-regional clinical trials, clinical research, and public health

Current Project

Global Regulatory Engagement

India Regulatory

India Regulatory

Working closely with Indian leaders to determine tractable solutions to regulatory reform issues.

Current Project

Global Regulatory Engagement

Optimizing International Pediatric Trials

Optimizing International Pediatric Trials

Generating and advancing a comprehensive series of harmonized tools for global pediatric research

Ethics, Conduct, and Oversight

Post-Trial Responsibilities

Post-Trial Responsibilities

Developing an ethical framework and toolkit for addressing post-trial responsibilities related to access to investigational product, access to medical care, and access to infrastructure.

Current Project

Ethics, Conduct, and Oversight

Proactive Safety Surveillance

Proactive Safety Surveillance

Improving upon the current safety surveillance systems by creating a global, cooperative approach for more proactive, predictive safety surveillance system(s).

Ethics, Conduct, and Oversight

Protocol Ethics

Protocol Ethics

Providing systematic guidance for protocol writers to address ethical considerations in planned clinical trials and for ethics committee members to ensure study protocols have adequately addressed ethical issues

Current Project

Global Regulatory Engagement

Real World Evidence

Real World Evidence

Investigating the reliability of evidence from retrospective database studies of medical claims and electronic medical records by engaging diverse stakeholders to determine study design

Current Project

Ethics, Conduct, and Oversight

Representation of Diverse Populations

Representation of Diverse Populations

Developing a systematic guidance document to enhance diversity in multi-regional clinical trials

Transparency

Return of Individual Results

Return of Individual Results

Providing Principles, Recommendations Document and Toolkit for returning individual results to study participants

Transparency

Return of Aggregate Results

Return of Aggregate Results

Providing Guidance Document and Toolkit for returning aggregate results to study participants; adapting to non-traditional medicine and non-Western culture

Transparency

Global Clinical Trial Data Sharing

Global Clinical Trial Data Sharing

Vivli promotes clinical data sharing with enhanced data discovery methods, hosting data, and bridging to other established repositories.