In July 2022, the MRCT Center delivered a virtual training for members of the newly established Data Safety Monitoring Committee (DSMC) at the National Institutes of Health at the University of the Philippines in Manila, Philippines. The training described the purpose, functioning, roles and responsibilities of a DMSC and how to review study data in an ongoing manner to make decisions for study continuation.
Focus Area: Capacity Building
Reimagining Health Data Exchange: An Application Programming Interface-Enabled Roadmap for India
Publication
Published on: July 13, 2018
Published in: Journal of Medical Internet Research
Strategic Global Meeting of the Joint Task Force for Clinical Trial Competency May 2022
Presentation / Proceeding
Presented on: May 20, 2022
Presented at: Strategic Global Meeting of Joint Task Force for Clinical Trial Competency (JTF) – Virtual Meeting
Self-assessed Competencies of Clinical Research Professionals and Recommendations for Further Education and Training
Publication
Published on: March 31, 2022
Published in: Therapeutic Innovation & Regulatory Science
The Joint Task Force for Clinical Trial Competency (JTF) conducted a global survey of clinical research professionals requesting respondents to self-assess their competencies in each of the eight domains of its Core Competency Framework version 3.1. The results were analyzed based upon role, years of experience, educational level, professional certification, institutional affiliation, and continuing education participation. Respondents with professional certification self-assessed their competencies in all domains at higher levels than those without professional certification. The survey demonstrated that irrespective of role, experience, or educational level, training curricula in both pre-professional and continuing professional education should include additional content relating to research methods, protocol design, medical product development and regulation, and data management and informatics. These results validate and extend the recommendations of a similar 2016 JTF and other surveys. We further recommend that clinical and translational research organizations and clinical sites assess training needs locally, using both subjective and objective measures of skill and knowledge.
MRCT Center virtual training inspires students and lecturers in Indonesia
In October 2021, the MRCT Center delivered seven modules as part of a 2-week clinical research virtual training to undergraduate and graduate students and lecturers participating in the Pfizer Biotech Fellowship program in Indonesia.
The curriculum was designed to introduce students to the process of drug discovery and development in clinical research, as well as inspire them with guest speakers sharing their personal experience.
Students who participated in the training were a part of 10 teams whose ideas have been selected for the development of health biotechnology ecosystem and policy environment. Participants will revise their concept papers based on what they learned during the training, and eventually three finalists will be chosen whose ideas propose solutions to some of the hottest issues in the biotechnology industry today.
Read an article in The Jakarta Post about this training.
MRCT Center conducts training with AVAREF
In partnership with the African Vaccine Regulatory Forum (AVAREF), the MRCT Center completed the first comprehensive training of ethics committee chairs and members selected from across Africa. Conducted as an intensive virtual training, 35 matriculants, representing 18 countries, completed the training. This commitment, and the AVAREF-MRCT Center partnership, represents the importance of the ethical conduct of clinical research, of harmonizing the process of review, and of increasing efficiency and oversight while protecting the individual.
MRCT Center Delivers Virtual Training in Algeria
In May and early June 2021, the MRCT Center delivered nine modules as part of a 2-month clinical research virtual training to pharmacy and biotechnology engineering students attending the University of Algiers, and The School of Engineering & Biotechnology in Constantine, Algeria. The curriculum was designed to introduce students to the process of drug development and clinical research, including research and development, bioethics, good clinical practice, regulatory requirements, as well as post-market surveillance and real-world evidence.
Capacity Building of Ethics Committees: an AVAREF-MRCT Center Collaboration
The African Vaccine Regulatory Forum (AVAREF) and the MRCT Center are initiating a partnership focused on capacity building of ethics committee members. AVAREF and the MRCT Center will collaborate to create and deliver an ethics training course for AVAREF country-members’ National Ethics Committees (NECs)/Institutional Review Boards (IRBs).
The purpose is to strengthen and augment the AVAREF country-member understanding of the ethical foundations of human participant research and their application to a variety of clinical research settings. An in-depth curriculum, offered virtually and leveraging cased-based learning, will focus on bioethics and best practices for the review and approval of clinical research, with the intention of enabling quality, efficiency, and the use of AVAREF standards and tools.
Read article here.
JTF Core Competency Framework Slides
Presentation
Developed on: June 2020
Developed by: Joint Task Force for Clinical Trial Competency
The JTF has developed this Powerpoint presentation that describes the Core Competency Framework and its uses. This presentation can be used for instructional purposes and for training programs.
Response to European Commission’s request for feedback regarding the General Data Protection Regulation (GDPR)
April 29, 2020
In response to the European Commission’s request for feedback regarding the General Data Protection Regulation (GDPR), Mark Barnes and Barbara Bierer, MRCT Center Faculty Co-directors, and Senior Advisor David Peloquin along with Rita Lawlor, Biobank Director & Research Coordinator, ARC-Net Research Centre, University of Verona, Italy, submitted feedback.
The response highlighted pragmatic solutions and proposed a cohesive approach that the Commission could pursue either through proposing amendments to GDPR in its report to the European Parliament under GDPR Article 97 or through dialogue with the European Data Protection Board and supervisory authorities.
