CHAIR
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PRESENTER
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Christian Yoder, National Institutes of Health, United States
Peggy Coyle has been working in Vietnam since 2006 managing a clinical research team of monitors, study managers and study support specialists. This team also provides capacity development in clinical research to sites and partners in Vietnam.
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Ms. Welch has supported clinical trials research for over 25 years, working for nonprofit and government institutions, with an emphasis on emerging infectious diseases. She currently works for SAIC-Frederick on projects in Southeast Asia funded by the National Institutes of Health.
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Description
The South East Asia Infectious Disease Clinical Research Network (SEAICRN), a collaborative partnership of hospitals and institutions in Thailand, Vietnam, Indonesia, and Singapore, embarked on a significant clinical research capacity building effort. Its key objective was to establish an experienced clinical research team comprising doctors, nurses, study coordinators, research pharmacists, lab technicians, data management and administrative personnel. To support this effort, the SEAICRN developed a new model for clinical trials support through the establishment of local clinical trials support specialists (CTSS). This session will present experiences with this new model and show how it can be applied successfully, as well as describe a capacity development project for a local ethics committee.
Learning Objectives:
Recognize that clinical research operations development can be built in to working with a trials site
Describe one model of such capacity development - the clinical trials support specialists
Discuss advantages to having an integrated capacity development team locally placed when developing clinical research operations in developing countries or new research sites.