News

The U.S. Food and Drug Administration (FDA) and the University of Texas Medical Branch are pleased to announce the 2026 Achieving Data Quality and Integrity in Clinical Trials Involving High Consequence Pathogens course. This free education opportunity will take place Tuesday, August 4 and Wednesday, August 5, 2026, in Galveston, Texas. A virtual option is also available.

Please note: In-person attendees are responsible for travel, hotel and related expenses.

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 (biosafety levels 4), 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.

Exciting KEY topics presented by outstanding faculty from FDA, NIH, UTMB, University of Minnesota, University of Nebraska, Rhodium Scientific and more! Don't miss out on:

• 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

To pre-register: please see the links below. In-person spots are limited!

In-person & Virtual pre-registration: https://utmb.us/g0y 

Deadline: July 20, 2026 

Note: Pre-registration does not guarantee a spot in the course. If accepted, you will receive a formal invitation email within a few weeks of pre-registering. 

Additional Information: For additional course details, local hotel recommendations, FAQs, etc., please visit: https://www.utmb.edu/orncs/regulatory-ops/clinical-course

Spread the word! Please share this course information and attached course flyer with your colleagues, newsletters, listservs and on social media. We appreciate your support and we hope to see you at the course!

If you have questions, please reply to me at Brianna.Skinner@fda.hhs.gov or contact the UTMB planning team at ORNcS@utmb.edu.

SEE: https://onehealthinitiative.com/wp-content/uploads/2026/07/2026-Clinical-Course-Flyer.pdf'