Promoting a set of harmonized competencies for training and qualification purposes of principal investigators.
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.
A forum to encourage the discussion of bioethical issues among stakeholders in global clinical trials for drug and device development
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.
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.
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.
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) .
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.
MRCT Center Executive Director, Rebecca Li, PhD, will be presenting at the DIA Clinical Trial Disclosure and Data Transparency Conference.
Dr. Barbara Bierer, MRCT Center Faculty Co-Director, will be presenting at the 2nd Annual Lay Summaries Summit in Philadelphia, PA.
The 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.