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

Registration

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 official invitation to the course from the University of Texas Medical Branch.

In-Person and Virtual Pre-registration is CLOSED!

2025 Clinical Course Flyer

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

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  • Day 1
    • The Importance of Clinical Research in the Global Infectious Disease Landscape
    • The One Health Initiative in MCM Development
    • Challenges of Emerging Infectious Disease Clinical Studies in an Outbreak vs. Epidemic Setting: What We Want vs. What We Can Do?
    • Bench to Bedside: How Medical Countermeasures Get Made
    • Writing Effective SOPs
    • Roles and Responsibilities of the IRB and Informed Consent
    • Operationalizing a Protocol
    • Sample Collection
  • Day 2
    • Roles and Responsibilities During a Clinical Study: Study Monitoring, Regulatory Requirements, Deviations vs. Serious Deviations
    • Preparedness Planning in Biocontainment Units
    • Overview of PPE Guidance
    • Tabletop Exercise / Culminating Scenario

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

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  • Pre-registration and Course Admittance

    Q1: Are there any fees associated with attending this course?

    A1: No! The course is funded by an educational grant through the U.S. Department of Health and Human Services Food and Drug Administration (FDA). In-person attendees will be responsible for expenses related to travel.

    Q2. What is the difference between pre-registration and course admittance?

    A2. Admittance to the course is a 2-step process. While course organizers try to accommodate all requests, the total number of attendees is limited; therefore, admittance is based on availability. After completion of Step 1, you will be notified if you have been admitted to the course. Please allow up to 30 days for the admissions process. Step 2 is your acceptance to the course invitation. Upon admission, you will receive additional information.

    Q3. I submitted my pre-registration information, but I have not yet heard whether I have been accepted into the course. What should I do?

    A3: First, please check your Spam folder to be sure that the email has not been blocked by a firewall. If you have not received notification after 30 days from completing Step 1 of the pre-registration process, please send an inquiry to orncs@utmb.edu. If you need to inquire on the status of your application in order to make travel reservations, you may also send an email to orncs@utmb.edu.

  • Registered Attendees

    Q4: I am attending the course and have a colleague who will benefit from this knowledge. Can I share the meeting link with them?

    A4: We are happy to hear that the content is relevant; however, we must track all attendees. If your colleague would like to have access, please email a request to orncs@utmb.edu and someone will contact them directly.

    Q5: I am attending the course in-person. Is it possible to attend some lectures in-person and some virtually?

    A5: At this time, all sessions require in-person attendance. Selected sessions will be offered for virtual attendance at a later date. If there are unusual circumstances that require flexibility, please email your request to orncs@utmb.edu and course organizers will do their best to accommodate.

    Q6: I registered and was admitted to the course to attend in-person; however, I am now unable to attend in-person. What should I do?

    A6: Please send an email to ORNcS@utmb.edu as soon as possible to discuss potential options.

    Q7: Will a certificate of completion be provided?

    A7: Yes, a certificate will be provided for those who attended the course in its entirety. If you experience an emergency that impacts your ability to participate fully, please email the course organizers at orncs@utmb.edu.

    Q8: I will need a VISA to enter the US to take this course. Will you provide any sponsorship?

    A8: You may use your course invitation and the meeting website to help support your request. If you require any further written documentation, please email your request to orncs@utmb.edu. Course organizers will try to accommodate by providing additional information as needed; however, we are unable to contact the respective Consulate directly. Please note that no financial assistance is available to offset travel expenses.

    Q9: Will Continuing Education credit be available for attendees?

    A9: Yes. Course organizers submit applications to certify the course for Continuing Nursing Education (CNE) and Registered Quality Assurance Professionals (RQAP). Once the course is approved, the accreditation information will be posted on the course website and Whova (course management application).  Instructions on how to claim credit will be provided at a later date.

    Q10: I am registered to attend the course, when can I expect to receive additional course information?

    A10: All registered attendees will receive an email approximately one week prior to the course start date that will contain additional information. If you do not receive information, check this website for general announcements or email orncs@utmb.edu.

    Q11: Will I need to download any applications prior to attendance?

    A11: The course will be administered through the WHOVA event management platform. Instructions will be provided on how to access the course. UTMB has received authorization by FDA IT for use by FDA employees. IF YOU ARE NOT ABLE TO DOWNLOAD THE WHOVA APPLICATION, please notify Katherine Rosen at kerosen@utmb.edu.  

    Q12: I did not indicate during course pre-registration that I wanted to take the online GCP course, but I would now like to take the course. What steps should I take?

    A12: Please email your first and last name along with your email address to orncs@utmb.edu and indicate that you would like to take the Basic GCP course. Course organizers will assure you are given access.

    Q13: I indicated my interest in taking the online GCP course. When will I have access to the course and how long will I have access?

    A13: You will receive an email from UTMB@Reach360.com with access information. Access will be granted for approximately six weeks starting 1-2 weeks prior to the course start date.

    Q14: Will the presentation slides be made available to attendees?

    A14: Presentations will be provided after the course for sessions where faculty provided consent to release. Some information may be redacted.

    Q15: Will sessions be recorded and available for attendees?

    A15: No, sessions will not be recorded for the purpose of viewing by course attendees. Some sessions may be recorded to aid in future course development.

    Q16: I am an in-person attendee and am planning to sign-in each day using the WHOVA App. Do I also need to physically sign-in each day?

    A16: Yes, please physically sign-in as you arrive each day.

  • Logistics

    Q17: Will there be parking on campus?

    A17:  Attendees will receive parking information in a Logistics email that will be sent approximately one week prior to the start of the course.

    Q18: Will lunch be provided?

    A18: No, lunch will be on your own. Information will be provided in a Logistics email that will be sent approximately one week prior to the start of the course.

  • Further Inquiries

    If you do not find an answer to your question, please send your inquiry to orncs@utmb.edu. Please include your name, email address, and state this is a question related to the UTMB/FDA Clinical Course.

Past Courses

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  • Course History by Year

    2024

    July 30 - August 4
    Live, Virtual

    2023

    October 4-6
    Live, Virtual

    2022

    July 11-13
    University of Nebraska Medical Center – Global Center for Health Security 
    Omaha, NE, USA
    Hybrid

    2021

    August 2-4, 2021
    Live, Virtual

    2020

    October 26-28
    Live, Virtual

    2019 – Pilot Course

    April 8-10, 2019
    National Institutes of Health (NIH)
    Bethesda, MD, USA

Davis 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

Omaha’s Henry Doorly Zoo and Aquarium
Bob Kerrey Pedestrian Bridge
Joslyn Castle & Gardens
Bemis Center for Contemporary Arts
The Old Market

Need More Information?

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

Please reference "Clinical Course" in Email Subject Title.