Recent Projects
Training
APEC Pilot Center of Excellence
The MRCT Center received endorsement to become an Asia-Pacific Economic Cooperation (APEC) Pilot Center of Excellence (CoE) for Multi-Regional Clinical Trials (MRCTs) and Good Clinical Practice (GCP) inspection.
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.
Data Transparency
Return of Individual Results
The MRCT Center previously developed guidelines for the return of aggregate results to research study participants; this project will focus on returning individual results to study participants.
Global Regulatory
India Regulatory
Working closely with Indian leaders to determine tractable solutions to regulatory reform issues.
Training
Clinical Research Professional Competency
Promoting a set of harmonized competencies for training and qualification purposes of principal investigators.
Ethical Frameworks
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
Focus Areas
News
Jun 14, 2017
Harmonized Core Competency Framework Version 2.0 Released for Public Comment
The Joint Task Force for Clinical Trial Competency (JTF) has released the Draft Version 2.0 of the Harmonized Core Competency Framework for public comment. This is an effort of a multi-stakeholder, widely representative workgroup from across the global clinical research community.
May 09, 2017
Joint Task Force for Clinical Trial Competency Launches Website
The Joint Task Force for Clinical Trial Competency (JTF) has launched its new website: ClinicalTrialCompetency.org. This site hosts the Harmonized Core Competency Framework, as well as the news about the JTF’s latest initiatives, events, and resources.
Apr 04, 2017
Vivli Attains Non-Profit 501(c)3 Status
The MRCT Center is delighted to announce that Vivli has been approved as a 501(c)3 non-profit organization!
Events
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Jul 10, 2017
Fourth Clinical Regulatory Medical Writing ForumDr. Carmen Aldinger, Program Manager, MRCT Center, will be presenting at the Fourth Clinical Regulatory Medical Writing Forum.
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Jul 24, 2017
2017 Ethical Issues in Global Health Research Workshop at Harvard T.H. Chan School of Public HealthMRCT Center Faculty Co-Directors, Dr. Barbara Bierer and Mark Barnes, will be speaking at the 2017 Ethical Issues in Global Health Research Workshop at Harvard T.H. Chan School of Public Health (Sponsored by PRIM&R), which will take place July 24 – 27, 2017 in Boston, MA.
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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.