Clinical Trials Unit – Support. Responsiveness. Flexibility.
The Clinical Trials Unit is responsible for the governance and operations of all OUCRU research in Viet Nam and internationally. To ensure that research is conducted to the highest standards and remains internationally leading, we work to develop research methods, management and understanding of ethical issues in research in Viet Nam. We manage more than 75 studies at any one time, and since our establishment in 2006 we have grown to have the expertise and capacity to deliver high quality clinical research.
Our CTU continuously aims to increase the research capacity of OUCRU and to enhance the quality of OUCRU clinical trials through monitoring and coordinating. We ensure adherence to local and international regulatory requirements and the principles of Good Clinical Practice. Our work includes building the human resources, facilities, oversight and administrative systems necessary for conducting an ever-growing number of clinical trials.
Leading and sharing.
While the base of our operations is in Ho Chi Minh City, the OUCRU CTU currently supports OUCRU centres in Hanoi, Nepal, Jakarta and Shantou. We also work with over 60 collaborating Vietnamese institutions and have developed close academic and scientific partnerships by:
- Developing research units with partner institutions;
- Building human and infrastructure capacity;
- Providing training and mentorship to support new clinical research teams; and
- Sharing the OUCRU CTU model and procedures across collaborator CTUs.
Clinical Research Ethics.
The OUCRU CTU is committed to bringing a broader scope to our more technical work. To that end, we are doing qualitative research in emerging issues in research methodology and ethics which are important to Viet Nam. As member of the Global Health Bioethics Network (GHBN) (link http://e-mops.ning.com) we have collaborated on multi-site studies exploring stakeholder perceptions of sharing research data. We are also conducting independent studies on issues we encounter every day in informed consent, compensation and perceptions of research. We aim to inform local policy development, by providing evidence-based recommendations for locally relevant issues.