Management of Multinational Trials
This training course is designed to familiarize personnel from clinical trial units and sites (project managers, clinical research assistants, etc. ) from the public and the private sector with the challenges of initiating and managing multinational trials. Many barriers can interfere and delay the initiation and the management of multinational clinical trials, the main objective of this course will be solution oriented to address the most common barriers in the European landscape. Among the obstacles, where vaccines are concerned, are the variety of national implementations of the European Regulation on clinical trials that govern the European clinical research as well as ethical considerations. The early identification of roles and responsibilities of all stakeholders, in both industry and academic research, as a key aspect to ensure good management of the clinical trial and effective harmonization among participating countries, will be covered. Another important consideration when conducting multinational clinical trials is the funding source and the budget preparation. Funding sources and key elements of planning a budget will be covered. The role of clinical trial data sharing and GDPR are also new difficulties that must be overcome when sharing sensitive data across borders. Primary considerations on how to plan clinical research that include data sharing plans, tools and services will be highlighted.
Further details following soon.