Training Course: Achieving Data Quality and Integrity in Clinical Trials Involving High-Consequence Pathogens
Current course | About this course | Course objectives and curriculum | Benefits of attending | Related links
Current course
Course Dates: August 4–5, 2026
Registration Information: In-Person and Virtual Registration (2-Day Course)
Deadline to register: July 20, 2026
Purpose: This course aims to educate various healthcare professionals, researchers, and regulators on best practices for conducting clinical trials during outbreaks involving High Consequence Pathogens. The course will focus on maintaining data quality and integrity according to FDA Good Clinical Practice regulations while addressing potential risks in these challenging scenarios.
Note: There is no cost to attend, but advance registration is required as spaces are limited. The course attendees are invited based upon diversity of roles, responsibilities, and organization. Interested participants will be placed on a waitlist once seats are filled.
About this course
History
Since 2013, FDA and the University of Texas Medical Branch, Galveston National Laboratory (UTMB) have collaborated to provide an annual training course on how to meet good laboratory practice (GLP) requirements in biosafety level (BSL)-4 facilities. This popular course offers a unique opportunity for the regulatory and scientific communities to discuss complex issues in an interactive environment and identify and share best practices for ensuring nonclinical data quality and integrity in BSL-4 facilities.
An additional clinical pilot course was introduced in 2019. The 2 1/2-day interactive pilot allowed participants to learn about clinical research protocols for high-consequence pathogens and help identify and mitigate barriers to data quality and integrity in domestic and international barrier environments involving medical countermeasures.
Based on demand and participant feedback, the pilot course was an overwhelming success and has expanded into a course that consists of classroom and practical hands-on instruction.
Venue Information
The 2026 FDA/UTMB Clinical Course will be held at the University of Texas Medical Branch (UTMB) in Galveston, Texas which is home to one of the nation's most advanced biocontainment facilities and a cornerstone of the federal infrastructure for managing high-consequence infectious diseases (HCIDs). UTMB serves as the Region VI Regional Emerging Special Pathogens Treatment Center (RESPTC), providing specialized clinical care across a five-state region encompassing Texas, Arkansas, Louisiana, Oklahoma, and New Mexico. Operating through UTMB's SPECTRE (Specialized Clinical Treatment and Research for Emerging Pathogens) program, the center is a premier, federally funded Level 1 biocontainment facility designed to deliver total-duration clinical care for patients infected with the most dangerous pathogens known, including Ebola and Marburg viruses.
Course participants will have the unique opportunity to conduct hands-on activities and clinical rotations within UTMB's state-of-the-art Biocontainment Care Unit (BCU) — a purpose-built, six-room, negative-pressure unit equipped with dedicated laboratory space and staffed by a highly specialized, multidisciplinary medical team. The BCU is engineered to the highest standards of infection control, enabling safe and effective care for patients with the most highly infectious pathogens while protecting healthcare workers and the surrounding community.
Beyond its patient care mission, the UTMB RESPTC serves as a vital national readiness hub, offering specialized training, developing regional emergency transport protocols, and advancing clinical research to strengthen the broader public health response framework. Participation in this course provides a rare, immersive experience within an operational biocontainment environment at the frontlines of emerging infectious disease preparedness. For more information about the UTMB Biocontainment Care Unit, please visit: https://www.utmb.edu/spectre/biocontainment-care-unit/bcu-home.
Purpose of course
The purpose of this unique educational course is to provide a learning environment that:
- Promotes collaboration
- Provides tools for conducting clinical studies
- Enhances mutual understanding of clinical, scientific, and regulatory complexities, and
- Promotes the data quality and integrity derived from these regulated studies.
A heightened awareness of the complexities and uniqueness of high- and maximum-containment environments for high-consequence pathogens is the first step in initiating a dialog to find solutions for the planning and execution of studies where data generated will be used to support a regulatory decision. The result is a better-prepared cohesive community of clinical, scientific, and regulatory experts mutually engaged in, and committed to, the development, research, and approval of medical countermeasures for high-consequence pathogens.
Professionals who have experience with high-consequence pathogen clinical trials are encouraged to register, including:
- Physicians
- Scientists
- Principal investigators
- Pharmacists
- Nurses and nurse practitioners
- Clinical laboratorians
- Clinical research staff and clinical monitors
- Regulators
- Policy-makers
- IRB professionals
- Biosafety professionals
- Industry sponsors
- Graduate Students
Course objectives and curriculum
Objectives
- Formulate solutions to regulatory, operational, and cultural challenges for the conduct of clinical trials of medical countermeasures for high-consequence pathogens
- Identify and mitigate risks to data quality and integrity
- Resolve complexities of performing clinical trials in biocontainment / barrier nursing environment under good clinical practices (GCPs)
- Gain experience conducting clinical research tasks in a mock biocontainment environment while wearing high-level personal protective equipment (PPE)
Course curriculum
- Addressing cultural and language barriers
- Ethical considerations for placebo-controlled studies
- Regulatory expectations
- Study monitoring
- Barrier nursing challenges
- Sample integrity
- Protocol development
- Operationalizing a protocol
- Protocol driven data collection vs. clinical data
- Good documentation practices
- Reporting adverse events
- International issues
- Stakeholder roles and responsibilities
Benefits of attending
- Attend this free course and earn continuing education (CE) credits.
- Learn from and network with world-renowned faculty members and subject matter experts.
- Apply best practices for clinical trials during an outbreak involving high-consequence pathogens.
- Recognize and prevent potential risks to data quality and integrity.
- Enhance cultural awareness and diversity involving clinical trials in geographic locations where outbreaks caused by high-consequence pathogens are frequent.
- Discuss the One Health approach for achieving optimal outcomes.
Attendees will also learn from integrated scenarios, case studies based on real-life experiences, and expert panels, along with lectures from experts from FDA, the National Institutes of Health, the NETEC, and clinical biocontainment units (BCUs).
Related links
- Current course, including registration information (UTMB)
- Sister course: Achieving Data Quality and Integrity in Maximum Containment Laboratories