Achieving Data Quality and Integrity in Clinical Trials Involving High Consequence Pathogens — Clinical CourseFDA-UTMB Collaborative Education Program

Course Dates: August 13-14, 2025

Course Format

In-person at UNMC.

Note: A limited virtual option for HHS employees who are not authorized to travel, and international attendees will be announced at a later date. Due to the interactive course design, only selected sessions will be offered virtually. Check back in late June for further updates. 

Course Fees

There are no fees associated with course attendance; however, travel expenses and meals are incurred at the individual’s expense.

Course Pre-registration

Course registration is a 2-step process. The first step is to pre-register for the course to indicate your interest in attending. After completing the pre-registration form, you will receive an email with a second link where you will complete a short survey that gathers information on your knowledge and experience. Notification of course admittance will follow, and step 2 is your confirmation of attendance.

Pre-registration is Open Now!

Click here for pre-registration

Pre-registration for in-person attendance closes July 18, 2025.

2025 Clinical Course Flyer - Coming Soon

For questions about pre-registration, please email orncs@utmb.edu.

Course Description

This two-day interactive course presents a valuable opportunity for participants to enhance their understanding of the FDA’s Good Clinical Practice (GCP) regulations. It is designed to guide effective integration of these principles into the planning, execution, and oversight of clinical research focused on medical countermeasures for high-consequence pathogens. Throughout the course, participants will engage in a blend of informative lectures, innovative learning platforms, and practical problem-based scenarios. This approach will prepare participants with tools to identify and address challenges related to GCP compliance ensuring data quality and integrity in biosafety level 4 clinical environments. Participants will explore constructive strategies for implementing GCP principles in a variety of settings, including complex and resource-limited conditions, both domestically and internationally. This hands-on learning experience will provide attendees with applicable considerations and solutions that can be tailored to their worksites.

The course features expert faculty composed of experienced clinicians, nurses, biosafety officers, government leaders, and representatives from federal agencies, all bringing invaluable real-world insights. Attendees will benefit from engaging with integrated scenarios, analyzing case studies based on real-life experiences, and participating in expert panel discussions through lectures and instructions from professionals affiliated with the US Food and Drug Administration (FDA), University of Texas Medical Branch (UTMB), University of Nebraska Medical Center (UNMC), and National Institutes of Health (NIH). Moreover, participants will receive comprehensive information about continuing education credits, allowing the recognition and validation of their commitment to professional development. This course is designed not only to expand public knowledge but to also help clinical professionals confidently apply learned principles to improve public health outcomes in their work. Join us and take an important step in advancing expertise in this clinical arena.

Target Audience

Physicians, Scientists, Principal Investigators, Physician Assistants, Nurse Practitioners, Nurses, Pharmacists, Clinical Laboratorians, Clinical Research Staff, Clinical Monitors, Regulators, Policymakers, Regulatory Reviewers, IRB Professionals, Biosafety Professionals, and Sponsors that have interest in clinical trials

2025 Planned Course TopicsDays and Titles are Subject to Change

Course Schedule

Course organizers are in the process of finalizing the 2025 course agenda. The tentative 2025 course schedule is listed below.

Attendees will be required to check-in between 8:00 am – 8:30 am CDT Wednesday, August 13, 2025.

August 13, 2025
8:30 am – 4:30 pm CDT

August 14, 2025
8:30 am – 4:30 pm CDT

Course Faculty

The Clinical Course faculty include clinicians, nurses, biosafety officers, government leaders, and federal agency representatives with field experience from the US Department of Health and Human Services Food and Drug Administration (FDA), National Institutes of Health (NIH), Biomedical Advanced Research and Development Authority (BARDA), United States Department of Agriculture (USDA), University of Nebraska Medical Center (UNMC), University of Texas Medical Branch (UTMB), and Emory University.

Prerequisite Knowledge

A basic understanding of Good Clinical Practice (GCP) is highly recommended. To meet this need, access to a free online course will be provided to course attendees.

  • Basic GCP — This interactive modular online course is designed to provide an overview of Good Clinical Practice (GCP). Content summarizes the basic elements of GCP. For the novice, this online course provides a good introduction of the topic; for those with prior knowledge of GCP, this course provides a refresher of the ethical and quality standards described in GCP. This course focuses on GCP regarding the conduct of clinical research studies involving the investigation of drugs and biologics.

Course Certification, Learning Objectives, and Learning Outcomes

Continuing Education: This course is submitted for Continuing Education credits for nurses and quality assurance professionals. Details will be posted closer to course dates.

Course Learning Objectives

  1. Formulate solutions to regulatory and operational challenges for the conduct of clinical trials during outbreaks of high consequence pathogens.
  2. Identify and mitigate risks to data quality and integrity.
  3. Resolve complexities of performing clinical trials in biocontainment / barrier nursing environment under GCP regulations.
  4. Experience the conduct of clinical research tasks in a mock biocontainment / barrier nursing environment while wearing high level PPE.

Course Learning Outcomes

  1. Utilize best practices for the design, implementation, and conduct of research clinical trials during an outbreak involving high consequence pathogens.
  2. Recognize and prevent potential risks to data quality and integrity.
  3. Apply the GCP principles to research clinical studies of medical countermeasures for high consequence pathogens.
  4. Mitigate data collection challenges in a biocontainment / barrier environment.

Course Location

The course will take place at the University of Nebraska Medical Center (UNMC) located in Omaha, Nebraska with interactive sessions at the Training, Simulation, and Quarantine Center located in the Global Center for Health Security at the Davis Global Center.

UNMC Global Center for Health Security
985551 Nebraska Medical Center
Omaha, Nebraska 68198 - 5551
USA

The Training, Simulation, and Quarantine Center (TSQC) provides a 6-bed high-fidelity simulated biocontainment unit training center, emergency operations center, laboratory, multipurpose room for incident management and skills training, and is the only federally-funded, 20-bed National Quarantine Unit (NQU) in the United States. To learn more about the TSQC and NQU, click here.

Course Hotels — Places to stay while in Omaha

Attendees are responsible for making their own hotel reservations; however, course organizers are working with a local hotel to secure a small block of rooms. Check back for more information.

Travel to and within Omaha

Omaha is accessible by air via Eppley Airfield (OMA). Visit https://www.flyoma.com/ for more information. Course attendees may want to extend their stay to enjoy the city!

Airport Information
https://www.flyoma.com/

Visit Omaha
https://www.visitomaha.com/ 

Henry Doorly Zoo and Aquarium
https://www.omahazoo.com/

Bob Kerrey Pedestrian Bridge
https://omaha.net/places/bob-kerrey-pedestrian-bridge

Joslyn Castle & Gardens
https://joslyncastle.com/tours/

Bemis Center for Contemporary Arts
https://www.bemiscenter.org/

The Old Market
https://oldmarket.com/

Course/Event Software Application

Course organizers utilize the WHOVA event management software for hosting the course. A link to the course site will be provided to registered course attendees (both in-person and virtual attendees) approximately 1 week prior to the course start date. Use of the Whova application has been approved for FDA employees.

Frequently Asked Questions

Past Courses

David Global Center

Testimonials

The course content was excellent, well thought out and engaging.
-2024 Attendee

I really like how the course is prepared and conducted.
-2024 Attendee

A great course! Many thanks to the organizers and the presenters for taking time to prepare and present their knowledge and experience!
– 2023 Attendee

This course is very beneficial for bridging a gap in this field.
– 2023 Attendee

As someone interested in BSL3-4 research, I found the hands-on training equally valuable. Perhaps more importantly, I was able to diversify my network and make the acquaintance of a number of high profile clinicians.
– 2022 Attendee

This course was very interesting. I learned some things that I was not aware of and enjoyed the presentations.
– 2022 Attendee

Great work! It was evident the preparation made by all was top notch and the delivery was outstanding!
– 2021 Attendee

This was a great course. I really enjoyed meeting colleagues and working together toward a common goal. The level of expertise in the room was immense and we all learned from each other to a great extent.
– 2019 (pilot course) Attendee

Highlighted Speakers

Information coming soon!

Omaha, Nebraska Highlights

Need More Information?

Send an email with your question to orncs@utmb.edu