Recent Projects
Capacity Building
Good Clinical Practice (GCP) and Multi-Regional Clinical Trials (MRCT) Training
Improving regulatory capacity to provide a unified standard for conducting clinical trials.
Ethics, Conduct, and Oversight
Research, Development, and Regulatory Roundtable (R3) of the MRCT Center and Ropes & Gray LLP
Transparency
Global Clinical Trial Data Sharing
Vivli promotes clinical data sharing with enhanced data discovery methods, hosting data, and bridging to other established repositories.
Capacity Building
Clinical Research Professional Competency
Promoting a set of harmonized competencies for training and qualification purposes of clinical research professionals.
Ethics, Conduct, and Oversight
Clarifying Data Sharing in Informed Consent
Disseminating templates for informed consent forms and data use agreement for broad data sharing purposes to use prospectively.
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
Aug 28, 2018
Introducing the Research, Development, and Regulatory Roundtable (R3) of Ropes & Gray LLP and the MRCT Center
The R3 provides a periodic, non-partisan forum wherein policymakers, regulators, legal counsel, and academicians may present, discuss, and deliberate cutting-edge issues in drug and device development, regulatory oversight of clinical trials, and human subjects research.
Jul 30, 2018
Recent Publications
Dr. Barbara Bierer, MRCT Center Faculty Director, co-authored Development of a Plain-Language Library of Educational Resources for Research Participants, recently published in the Journal of Clinical and Translational Research.
Jul 30, 2018
MRCT Center and Ropes & Gray GDPR Conference
In collaboration with Ropes & Gray LLP, the MRCT Center hosted a closed, one-day roundtable on Monday, July 30th.
Resources
-
Oct 22, 2018
Leveling the Joint Task Force Core Competencies for Clinical Research Professionals (Publication) -
Oct 17, 2018
Return of Individual Results to Participants – From Theory to Practice (Presentation – Login Required) -
Sep 24, 2018
Truth in Advertising: Disclosure of Participant Payment in Research Recruitment Materials (Publication)
Events
-
Nov 15, 2018
PRIM&R’s 2018 Advancing Ethical Research ConferenceSarah White, MRCT Center Executive Director, will co-present (1) ClinicalTrials.gov: How Academic Institutions Can Respond to New Clinical Trial Disclosure Requirements and (2) Ideas and Practices for for Compliance and Auditing of Single IRB Studies at the Advancing Ethical Research Conference.
-
Dec 05, 2018
MRCT Center Annual MeetingThe MRCT Center Annual Meeting will be held in the morning of December 5, 2018 (8:00 AM -1:00 PM).
-
Jan 22, 2019
MRCT Center Bioethics CollaborativeThe MRCT Center is planning the seventh meeting of the Bioethics Collaborative, which will be held at Ropes & Gray, LLP in Boston, MA on Tuesday, January 22nd, 2019.