Recent Projects
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.
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.
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.
Focus Areas
News
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) .
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.
Resources
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Aug 21, 2017
2017-06-20 Presentation: Post-Trial Responsibilities to Research Participants (Login Required) -
Aug 18, 2017
2017-07-25 Presentation: Guiding Principles for Clinical Trials (LOGIN REQUIRED) -
Aug 18, 2017
2017-07-10 Presentation: Fourth Clinical Regulatory Medical Writing Forum (Login Required)
Events
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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.
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Dec 06, 2017
MRCT Center 2017 Annual MeetingThe MRCT Center Annual Meeting is open to all MRCT Center stakeholders and the public. It will be held from 8:00 AM – 12:45 PM at the Harvard Faculty Club. For registration, please click here.