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

Registration

Course Dates: August 4-5, 2025

Course Format

In-person at the University of Texas Medical Branch at Galveston (UTMB) in Galveston, Texas, USA, an virtual on Whova Event Management Platform.

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.

Pre-registration opens in May 2026!
Check back soon!

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.

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 Planned Course TopicsDays and Titles are Subject to Change

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  • Course 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.

      • 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

Course Schedule

Course organizers are in the process of finalizing the 2026 course agenda. The tentative 2025 course schedule is listed below.

Attendees will be required to check in before the start time on Day 1 (August 4, 2026). Details will be provided after the agenda is finalized. Lunch will be provided on both days.

August 4, 2025
8:30 am – 4:30 pm CDT

August 5, 2025
8:30 am – 4:30 pm CDT

Course 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).

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 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.

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 Galveston

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:


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:  In-person attendance is limited. 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: 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

     

  • 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

    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
    University of Nebraska Medical Center – Global Center for Health Security 
    Omaha, NE, USA
    Live, Virtual

    2023

    October 4-6
    University of Nebraska Medical Center – Global Center for Health Security 
    Omaha, NE, USA
    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

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 (LinkedIn post)

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

The event is delivering relevant content and network opportunities that will contribute in many ways in my career. Thanks for the organizers.
-2025 Attendee

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!

Need More Information?

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

Please reference "Clinical Course" in Email Subject Title.