Background
Year: 2017
Funding: US government contract
Location: Monrovia, Liberia
The team included:
- One expert trainer from
FHI Clinical - Two expert trainers from the University of Minnesota
- FHI Clinical project manager with instructional design expertise
- Monrovia-based logistics support
- Local Liberian regulatory expert
SERVICES PROVIDED
The training team provided a week-long training course on clinical research fundamentals to 25 participants, most of whom were inexperienced in the conduct of clinical research. The trainee group was diverse and included leaders from the National Public Health Institute of Liberia and the Liberian Institute of Biomedical Research, University of Liberia students and faculty, Liberian Ministry of Health officials and PREVAIL staff members.
The trainers all had extensive capacity building and clinical research experience in limited-resource countries, and two of the trainers had previous experience in Liberia. Each training team member also had decades of experience providing high-quality clinical trial training in resource-constrained settings.
The training covered the basics of clinical research, including study design and writing protocols, Good Clinical Practice (ICH-GCP) and the operational nuts and bolts of clinical trial implementation. The team used existing training materials where possible and developed new training materials when needed. Hands-on learning activities (case studies, role-playing and small-group exercises) were integrated throughout the training to provide a meaningful, engaging learning experience.
Training topics included:
- Scientific concepts and research design
- Medicines development and regulation
- Data collection, management and informatics
- Ethical and participant safety considerations, clinical trials operations
- Roles and responsibilities of safety oversight bodies, such as Institutional Review Boards (IRBs) and Data Safety Monitoring Boards (DSMBs)
- Study and site management
- Communication and teamwork in clinical research
