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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.
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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
Improving the design and the quality of clinical trial reporting will result in a reduction in the number of non-informative trials that are initiated.
Defining key principles of data protection and anonymization and working towards international harmonization of standards to enable clinical data sharing
A forum to encourage the discussion of bioethical issues among stakeholders in global clinical trials for drug and device development
Providing training to ensure those tasked with adjudicating causality are up-to-date on latest methods in causality determination and have practical scenarios.
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).
Developed a systematic guidance document and supplementary toolkit to enhance diversity in multi-regional clinical trials
Improving regulatory capacity to provide a unified standard for conducting clinical trials.
Working closely with international regulators to determine tractable solutions to regulatory reform issues.
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.
An effort to understand the key issues and implications of the GDPR on multi-regional clinical trials, clinical research, and public health
Promoting a set of harmonized competencies for training and qualification purposes of clinical research professionals.
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.
Improving upon the current safety surveillance systems by creating a global, cooperative approach for more proactive, predictive safety surveillance system(s).
Identifying and advancing ethical approaches, guidance, and actionable tools to enable effective enrollment in pediatric studies and responsibly analyzed, interpreted and communicated data.
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
Investigating the reliability of evidence from retrospective database studies of medical claims and electronic medical records by engaging diverse stakeholders to determine study design
Accurate health and research information from trusted, reliable sources is needed. The MRCT Center created a website specifically for patients, potential participants, and the public.
Providing Guidance Document and Toolkit for returning aggregate results to study participants; adapting to non-traditional medicine and non-Western culture
Providing Principles, Recommendations Document and Toolkit for returning individual results to study participants
Developing harmonized governance tools for data sharing, enhance data transparency and collaboration, reduce administrative barriers, shorten the time to new discovery
Vivli promotes clinical data sharing with enhanced data discovery methods, hosting data, and bridging to other established repositories.