Developed by: MRCT Center, in collaboration with the World Health Organization
Description: This course was developed in partnership with the World Health Organization and aims to meet the growing demand for a training on the scientific and ethical aspects of interventional clinical trials. This course is tailored to research ethics committee members, chairs, administrative staff, and others who review clinical trial protocols. It will also benefit regulators, investigators, study staff, care providers, and others involved in clinical trials. This course is available free of charge worldwide.
Developed by: Joint Task Force for Clinical Trial Competency (JTF), Roche Portugal, and Agency for Clinical Research and Biomedical Innovation (AICIB).
Description: Sylvia Baedorf Kassis and Barbara E. Bierer were co-authors on a paper published in “Cancer” entitled “Acupuncture for hot flashes in hormone receptor‐positive breast cancer: A pooled analysis of individual patient data from parallel randomized trials.” The MRCT Center helped advise the study teams in the coordination and conduct of multi-national, collaborative research.
Developed by: Joint Task Force for Clinical Trial Competency (JTF), National Center for Health Research (NCHR) Ministry of Health and Prevention United Arab Emirates, Phoenix Clinical Research, Lebanese American University, and Sanofi.
Developed by: Joint Task Force for Clinical Trial Competency (JTF), Comprehensive and Integrative Medicine Institute (CIMI), Medical Statistics and Informatics, Daegu Catholic University Medical Center (MSI, DCUMC)
Comments provided to:US Food & Drug Administration
The MRCT Center submitted comments in response to the FDA/ICH E6(R3) Guideline for Good Clinical Practice; International Council for Harmonisation; Draft Guideline for Industry (FDA-2023-D-1955-0002). The MRCT Center applauds the overall structural redesign of the E6(R3) GCP guideline and enthusiastically supports the proposed changes. Our comments identified specific areas that we believe, with revision and improvement, will further protect the rights, safety and well-being of all trial participants.
