Published in: BMC Complementary Medicine and Therapies
Sylvia Baedorf Kassis, Sarah A. White, Barbara E. Bierer and others co-authored “Developing and implementing a self-monitoring toolkit for a coordinated multinational randomized acupuncture trial,” published in BMC Complementary Medicine and Therapies, which describes a self-monitoring toolkit that was developed and implemented in a coordinated multinational trial that involved sites in China, South Korea, and the U.S. Authors conclude that such a tool “provides a feasible, consistent, and effective way to review the collection and maintenance of data and regulatory documentation for quality assessment in minimal risk clinical research studies and can augment formal study monitoring activities.”
Developed by: Joint Task Force for Clinical Trial Competency / Universitas Indonesia, Faculty of Medicine / NCGM (National Center for Global Health and Medicine) Japan
The objective of this workshop was to agree on a consensus list of “key selection standards or criteria for sites and Principal Investigators,” to propose methods to quantify the importance of these criteria, and to make recommendations for the MRCT Center’s role moving these issues forward
The objective of this meeting was to provide an update to all stakeholders regarding current initiatives and progress, engage regulators in the MRCT Center initiatives and mission, obtain feedback from regulators and stakeholders on MRCT Center’s ongoing and planned initiatives, and discuss the 2013 Budget and Proposed Goals.
The MRCT Center Annual Meeting provided an opportunity to update stakeholders on current initiatives and discuss key Clinical Data Sharing Projects including, Practical Implementation of Clinical Trial Data Sharing and Return of Individual Results to Patients.
The Harvard MRCT Annual Meeting 2014 focused on the Guidance Document and Toolkit that the Harvard MRCT workgroup developed for returning aggregate results to study participants and included a panel with various stakeholder perspectives on returning of results. In addition, Harvard MRCT co-directors introduced their work of addressing regulatory, trial causality and compensation issues in India.
To facilitate discussion on acceleration of simultaneous drug development around the world, Beijing Biometrics Association (BBA) – Beijing Biometrics Forum (BBF) organized this joint symposium on recent advances in the design and conduct Multi-Regional Clinical Trials (MRCTs).
The MRCT Center will host a workshop to discuss the evolution of a harmonized framework of core competencies for clinical research professionals and its application to real world experiences.
Fifteen real life case studies applying the core competencies by industry, professional societies and academia in the US and global settings will be presented.
This will be an opportunity to learn more about the application of the core competencies for those seeking to apply the competencies in their own environment. Also the workshop will provide an opportunity for participants to provide feedback and discuss potential future revisions for the competency framework. Potential future projects for the work group will also be discussed.
Pilot Training on International Conference on Harmonisation Good Clinical Practice (ICH GCP): The MRCT Center is hosting a 3-day training for international regulators and professionals on ICH GCP.
