This interactive, scenario-driven training course equips clinical research professionals with the skills to ensure informed consent is obtained from the right subject, using the correct forms, by authorized personnel, through a compliant process, at the appropriate time—with complete and accurate documentation.
Form FDA 1572 doesn’t have to be complicated. This practical training course equips sponsor personnel and site staff with the knowledge and tools to complete the Statement of Investigator accurately and confidently—right from the start.
This course provides a solid foundation to the key concepts and principles outlined in ICH GCP E6(R3). Through focused microlearning modules, real-world scenarios, and relevant knowledge checks, you’ll gain a deeper understanding of the guideline’s application in clinical trials to navigate the complexities of clinical research.
This webinar invited you to pause and reflect on the ethical foundations that safeguard human participants in research. We explored the historical milestones that shaped today’s protections, examining how past research abuses led to the creation of oversight structures like the Belmont Report and Institutional Review Boards (IRBs).
David Burrow, PharmD, JD, explored foundational principles of Quality by Design (QbD), including Critical to Quality (CTQ) factors and Risk-Based Quality Management Systems (RBQM). Participants gained strategic insights into how to enhance trial quality while reducing regulatory uncertainty through forward-thinking approaches and practical tools.