Building on the success of the 2017 course, the program teaches best practices for coordinating the clinical trial process including study design and protocol development, ethics, GCP, data management, regulatory affairs, safety monitoring and practical management skills.
The course is free for successful applicants and will benefit study coordinators working in all disease areas.
At the end of the course, successful participants will be able to:
- Prepare sites for clinical trial start up through an overall understanding of the clinical trial process from project management to research design and protocol development.
- Demonstrate the ability to effectively conduct clinical trials using patient recruitment and retention approaches, data management, data monitoring, pharmacovigilance, safety reporting and good financial practices.
- Design and maintain the quality system of a clinical trial through implementing SOPs, handling audits and inspections, as well as other aspects of QA and QC.
- Identify and address key challenges in managing research sites including developing and maintaining capacity, doing community engagement and managing grants.
- Develop people management skills and techniques that will be useful in working with internal colleagues and external partners
The module is an official executive course from the Institute for Global Health-University of Siena, organized and coordinated by the Faculty of Capacity Development. Learners who pass the assessment are awarded a certificate by the University. Learners who complete the course but choose not to take the assessment will receive a Certificate of Completion from FCD.
For more information download the brochure [PDF: 8 pages, 5Mb]