Clinical Course FDA-UTMB Collaborative Education Program

Achieving Data Quality and Integrity in Clinical Trials Involving High Consequence Pathogens.

Details & Registration

Dates: August 4-5, 2026

Location: The University of Texas Medical Branch (UTMB) in Galveston, Texas

Format: Available in person or online

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

Registration: Registration is now closed.

Please reach out to orncs@utmb.edu with any questions about pre-registration.


View the 2026 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, and to understand, plan, and operationalize clinical research studies for high-consequence infectious diseases (HCID) and emerging infectious diseases, with emphasis on One Health, medical countermeasure (MCM) development, study oversight, high-level isolation unit (HLIU) operations, and hands-on skills. This course is designed to guide effective integration of GCP 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.

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  • 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, Quality Assurance Professionals, and Sponsors that have interest in clinical trials.

  • 2026 Topics

    The course will utilize a single case study that progresses across the 2 days. The case will begin with the emergence of a suspected HCID event and evolve through clinical presentation, containment, protocol selection, regulatory review, consent, investigational product use, specimen collection, documentation, and ethical decision-making. A key feature of the course is an applied training component using the UTMB Biocontainment Care Unit (BCU). Participants will rotate through practical stations tied to the workshop case study.

    Dates and titles are subject to change.

    • One Health and the HCID Landscape
    • Why Clinical Research Matters
    • One Health and MCM Development
    • Clinical Trials in the HLIU vs. in the Field
    • Clinical Studies in Outbreak and Endemic Settings
    • Why Prospectively Planned
    • Clinical Trials Must be Included
    • Clinical Trials, eIND, and Expanded Access
    • Types of Studies in HCID Research
    • Study Protocols and Study Start-Up
    • IRB and IBC—Roles and Responsibilities
    • SOP Development and Operational Readiness
    • Informed Consent in the HLIU
    • How MCMs are Made, Acquired, Prepared, and Administered
    • Sample Collection, Integrity, and Shipping
    • Documentation, Deviations, and Sponsor Data Needs
    • Hands-on Activities in the HLIU
    • Bioethics Debrief, Course Wrap-up, and Post-Assessment

  • Schedule

    Course organizers are in the process of finalizing the next course agenda.

  • Faculty

    The Clinical Course faculty include clinicians, nurses, biosafety officers, and government leaders with representation from the Regional Ebola and other Special Pathogen Treatment Centers (RESTPC), Special Pathogens Research Network (SPRN), and UTMB’s Special Pathogens Excellence in Clinical Treatment, Readiness, and Education Program (SPECTRE).

  • Highlighted Speakers

    Coming soon.

  • More Information

    For additional questions, email orncs@utmb.edu and include Clinical Course in the subject line.

Testimonials

Slide left to see more testimonials.

  • Testimonials 1
    What made this course exceptional was its blend of informative lectures, interactive platforms, and expert-led discussions, equipping us with tools to protect public health through reliable, ethical, and compliant clinical research.–2025 Attendee
  • Testimonials 2
    I enjoyed the entire seminar, each of the presenters and the information/slides presented were interesting and kept all engaged. I have recommended the course to upper management as one of the best courses I’ve attended. – 2025 Attendee
  • Testimonials 3
    The event is delivering relevant content and network opportunities that will contribute in many ways in my career. Thanks for the organizers.– 2025 Attendee
  • Testimonials 4
    The course content was excellent, well thought out and engaging. – 2024 Attendee
  • Testimonials 5
    I really like how the course is prepared and conducted.– 2024 Attendee
  • Testimonials 6
    A great course! Many thanks to the organizers and the presenters for taking time to prepare and present their knowledge and experience!– 2023 Attendee
  • Testimonials 7
    This course is very beneficial for bridging a gap in this field.– 2023 Attendee
  • Testimonials 8
    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
  • Testimonials 9
    This course was very interesting. I learned some things that I was not aware of and enjoyed the presentations.– 2022 Attendee
  • Testimonials 10
    Great work! It was evident the preparation made by all was top notch and the delivery was outstanding!– 2021 Attendee
  • Testimonials 11
    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

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 Credits, Learning Objectives, and Learning Outcomes

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

  • Learning Objectives
    • Formulate solutions to regulatory and operational challenges for the conduct of clinical trials during outbreaks of 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 regulations.
    • Experience the conduct of clinical research tasks in a mock biocontainment / barrier nursing environment while wearing high level PPE.

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

About the Location

The course will take place at the University of Texas Medical Branch in Galveston, Texas. 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.

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  • Hotels

    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.

    A limited number of rooms are available at Homewood Suites by Hilton - Galveston, 110 Seawall Blvd., on the Galveston Seawall. Rooms are available at a rate of $186 per night, which includes breakfast. Rooms are based on availability. Room rates are subject to state and local taxes. The onsite parking rate is $15 per night. Please use this booking link to reserve a room at Homewood Suites.

    For information about other Galveston area hotels, please check the Visit Galveston website.

  • Transportation

    Galveston is accessible via two airports: William H. Hobby Airport within 40 miles and George Bush Intercontinental Airport within 70 miles. Both support domestic and international travelers. For information, visit the Houston Airport System website.

    Transportation from these airports to Galveston and within Galveston is best secured by commercial taxi or commercial ride services such as Uber and Lyft. Galveston Limousine operates a shuttle to Galveston from both airports. However, as such transportation can be expensive, course attendees might instead want to rent a vehicle. A rented vehicle will also support their visits to Galveston sites outside of Moody Gardens. For instance, course visitors may want to plan a short trip to enjoy the beach or to visit Galveston’s downtown area, many restaurants, or other tourist sites.

  • Tourism Resources

Course Platform

Course organizers use Whova, an event management platform, to host course information and resources. Registered attendees, both in person and virtual, will receive a link to the course site approximately one week before the course begins.

Whova has been approved for use by FDA employees.

Frequently Asked Questions

If you cannot find the information you need, email orncs@utmb.edu. Please include your name and email address and note that your question is about the UTMB/FDA Clinical Course.

Pre-registration and Course Admittance

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Logistics

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  • Will there be parking on campus?

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

  • Will lunch be provided?

    Yes! Lunch will be included. Please include any food allergies on your pre-registration form. If you forgot, please send an email to orncs@utmb.edu no later than one week prior to the first day of the course

Registered Attendees

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Past Courses by Year

2025

August 13-14
University of Nebraska Medical Center – Global Center for Health Security Omaha, NE, USA
Live, Limited Virtual Sessions

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