Recent Projects
Ethics, Conduct, and Oversight
Bioethics Collaborative
A forum to encourage the discussion of bioethical issues among stakeholders in global clinical trials for drug and device development
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.
Capacity Building
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).
Capacity Building
Clinical Research Professional Competency
Promoting a set of harmonized competencies for training and qualification purposes of principal investigators.
Capacity Building
Causality training
Providing training to ensure those tasked with adjudicating causality are up-to-date on latest methods in causality determination and have practical scenarios.
Ethics, Conduct, and Oversight
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 22, 2018
Bioethics Collaborative Meeting Summary Notes Released
The MRCT Center Bioethics Collaborative is delighted to share a very brief summary of the April 24, 2018 discussion related to Return of Individual Results to Research Participants and Axes of Communication. Read the summary here
Apr 25, 2018
Successful APEC Center of Excellence Training Workshop on Multi-Regional Clinical Trials (MRCT) and Good Clinical Practice (GCP)
In April 2018, the MRCT Center held a 3 1/2-day training workshop at the Harvard Faculty Club focused on Multi-Regional Clinical Trials (MRCT) and Good Clinical Practice (GCP) as an APEC (Asia-Pacific Economic Cooperation) Pilot Center of Excellence (CoE), and specifically on ICH-E17 and ICH-E6(R2).
Mar 12, 2018
Global Regulatory Engagement: Mexico
Faculty Director Barbara Bierer, MD, traveled to Mexico City, Mexico, in February to learn more about the national preparedness for clinical trials.
Resources
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Jun 11, 2018
2018-06-11 Bioethics Collaborative: Return of Individual Results to Research Participants and Axes of Communication -
Apr 19, 2018
2018-04-05 Other Resource: Essential Elements of Ethics User Statistics Dec 2017 -
Mar 16, 2018
2018-03-16 Public Comments: Regulation of New Drugs and Clinical Trials Rules: Comments and Rocommendations (LOGIN REQUIRED)
Events
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Jul 19, 2018
Vivli Platform LaunchThe official launch of the Vivli platform will take place at the National Academies in Washington D.C. on July 19, 2018.
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Jul 30, 2018
GDPR ConferenceRopes & Gray LLP and the MRCT Center will co-host a one-day conference focusing on the effect of the European Union General Data Protection Regulations on clinical research, big data research and data repositories/ biorepositories.
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Aug 13, 2018
2nd Disclosure and Transparency for Clinical Data SummitDr, Carmen Aldinger, MRCT Center Administrative and Training Manager, will present on Sharing Aggregate and Individual Results of Clinical Trials with Study Participants. Find more information on the conference here