Mitigate risk and improve regulatory compliance with insider advice from FDA officials and industry experts. This online, interactive program features FDA officials and industry experts addressing CDER BIMO compliance and enforcement, FDA inspections, ClinicalTrials.gov requirements, and more.
When in need of a comprehensive refresher, this on-demand eLearning course provides a consolidated overview on the history and importance of ethical conduct in clinical trials involving human subjects.
Improve your consent process by learning how to assess a participant’s reading level, health literacy, and overall understanding of clinical trial participation and address culture, learning styles, emotional states and language. This eLearning course will provide essential tools for those directly involved in informed consent discussions.
Fundamental education about the role clinical research plays in advancing medical knowledge and the work conducted by clinical research professionals. This free eLearning course details how medical products are developed, how volunteer patients are protected, and key roles in the development, research, review, and approval of medical products.
Master quality-related processes and procedures required to ensure trial compliance. This eLearning course is a comprehensive training program that prepares you for the next step of setting up a quality management system– essential information for site personnel involved in quality management and improvement.