2023 course dates to be announced. Please check back later for more information!
This two and one half-day interactive course allows 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 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 nursing environments.
Course faculty include clinicians, nurses, biosafety officers, government leaders, and federal agency representatives with field experience. Attendees will learn from integrated scenarios, case studies based on real-life experiences, and expert panels,
along with lectures from experts from FDA, the National Institutes of Health, the National Emerging Special Pathogen Training and Education Center (NETEC), and clinical biocontainment units (BCUs).
A basic understanding of Good Clinical Practices is highly recommended. To meet this need, access to a free online course will be provided to course attendees:
- Basic GCP Training -- This self-pace module on-line course is designed to provide attendees with a general understanding of good clinical practices when conducting, or participating in, clinical research trials.
Credits awarded: This course is submitted for Continuing Education credits for physicians, nurses, and quality assurance professionals. Details are posted closer to course dates.
Target Audience: Physicians, Scientists, Principal Investigators, Physician Assistants, Nurse Practitioners, Nurses, Pharmacists, Clinical laboratorians, Clinical research staff, Regulators, Policy-makers, Regulatory reviewers, Biosafety
professionals, IRB professionals, Sponsors, and sponsor monitors.
Course Fees: There is no cost to attend, but seating is limited and pre-registration is required. Note that course attendees are invited based upon diversity of roles, responsibilities, and organization. Interested participants will be
placed on a waitlist once seats are filled.
Location: The University of Nebraska Medical Center, Omaha NE, USA
Overall Course Learning Objectives:
- Formulate solutions to regulatory, operational, and cultural challenges for the conduct of clinical trials of medical countermeasures for high consequence pathogens
- Identify and mitigate risks to data quality and integrity
- Resolve complexities of performing clinical trials in biocontainment / barrier nursing environment under GCP
- Experience conduct of clinical research tasks in a mock biocontainment environment while wearing high level PPE
Overall Course Learning Outcomes:
- Develop best practices for the design and implementation of research clinical trials during an outbreak involving high consequence pathogens.
- Recognize and prevent potential risks to data quality and integrity
- Application of the GCP principles to research clinical studies of medical countermeasures for high consequence pathogens.
- Better understanding of the clinical, research, and regulatory community on the challenges of data collection in a biocontainment/barrier environment.