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
2023 Dates - TBA (Omaha, Nebraska)
There is no cost to attend, but seating is limited, and pre-registration is required. Note that 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
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. This 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.
About the venue
The 2022 course was held virtually with staff from the National Training, Simulation and Quarantine Center (TSQC) at University of Nebraska Medical Center/Nebraska Medicine. The center is a National Ebola Training and Education Center (NETEC) facility specially designed in the wake of the 2014 Ebola epidemic in West Africa through a collaboration between the University of Nebraska Medical Center Global Center for Health Security, Emory University, and Bellevue Hospital Center in New York City. TSQC was funded by the U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response (HHS ASPR) to support the U.S. public health and healthcare systems in safely and effectively preparing for and managing individuals with suspected or confirmed infection with high-consequence special pathogens, such as Ebola.
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:
- Principal investigators
- Physician assistants
- Nurses and nurse practitioners
- Clinical laboratorians
- Clinical research staff and clinical monitors
- Regulators and regulatory reviewers
- IRB professionals
- Industry sponsors
Course objectives and curriculum
- 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)
- 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 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.
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).
- Current course, including registration information (UTMB)
- Sister course: Achieving Data Quality and Integrity in Maximum Containment Laboratories