UNMC’s Global Center for Health Security and the FDA-University of Texas Medical Branch Collaborative Program are hosting the FDA-sponsored “Achieving Data Quality and Integrity in Clinical Trials Involving High Consequence Pathogens” clinical course from July 30-Aug. 1.
There are no fees associated with course attendance, and the event is in-person and virtual, although seating for in-person attendance is limited. The course will run three days for in-person attendees and two days for virtual attendance.
This interactive course will allow participants to enhance knowledge and integrate practical considerations for the planning and operation of clinical research protocols involving medical countermeasures for high consequence pathogens. Course participants will acquire knowledge through innovative learning platforms and problem-based scenarios that help identify and mitigate barriers to data quality and integrity in domestic and international barrier environments.
The third day of the course, for in-person attendees, will focus on workplace risk assessments, donning and doffing of high-level PPE, waste management and simulation exercises in a mock barrier environment. These activities will take place at UNMC’s Training, Simulation and Quarantine Center. The Training, Simulation and Quarantine Center provides a six-bed, high-fidelity simulated biocontainment unit training center, emergency operations center, laboratory, multipurpose room for incident management and skills training. It is the only federally-funded, 20-bed National Quarantine Unit in the United States.
The target audience for this event includes physicians, scientists, principal investigators, physician assistants, nurse practitioners, nurses, pharmacists, clinical laboratorians, clinical research staff and students, students interested in clinical research, regulators, policy-makers, clinical monitors, regulatory reviewers, biosafety professionals, IRB professionals and sponsors.
This course is submitted for Continuing Education credits.
For more information, course learning objectives and registration, see this website and this course flyer.