Recent Projects
Training
ICH Good Clinical Practice (GCP) Training
Improving regulatory capacity to provide a unified standard for conducting clinical trials.
Training
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).
Training
Clinical Research Professional Competency
Promoting a set of harmonized competencies for training and qualification purposes of principal investigators.
Ethical Frameworks
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.
Ethical Frameworks
MRCT Bioethics Collaborative
A forum to encourage the discussion of bioethical issues among stakeholders in global clinical trials for drug and device development
Data Transparency
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 and to returning individual results.
Focus Areas
News
Oct 16, 2017
Plain Language Summary Guidance Document Submitted to the FDA – open for comments
The MRCT Center, in collaboration with TransCelerate Biopharma, Inc. submitted to FDA for consideration a draft guidance document on provision of plain language summaries for study participants.
Sep 07, 2017
Version 2.0 of Core Competency Framework for Clinical Research Professionals Released
The Joint Task Force (JTF) for Clinical Trial Competency has updated and released its Core Competency Framework Version 2.0 for use by clinical research professionals and staff worldwide.
Aug 28, 2017
Post-Trial Responsibilities Framework Released
We have released the MRCT Center Post-Trial Responsibilities Framework: Continued Access to Investigational Medicines. This framework consists of two parts: a Guidance Document (Version 1.1) and a Toolkit (Version 1.0) .
Resources
Events
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Oct 17, 2017
ICH GCP Pilot TrainingPilot Training on International Conference on Harmonisation Good Clinical Practice (ICH GCP): The MRCT center is hosting a 3-day training for international regulators and professionals on ICH GCP.
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Sep 14, 2017
DIA Clinical Trial Disclosure and Data Transparency ConferenceMRCT Center Executive Director, Rebecca Li, PhD, will be presenting at the DIA Clinical Trial Disclosure and Data Transparency Conference.
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Sep 26, 2017
2nd Annual Lay Summaries SummitDr. Barbara Bierer, MRCT Center Faculty Co-Director, will be presenting at the 2nd Annual Lay Summaries Summit in Philadelphia, PA.