The FDA and the University of Texas Medical Branch, Galveston National Laboratory (UTMB) are sponsoring an annual training course 27-30 July 2020 on how to meet good laboratory practice (GLP) requirements in biosafety level (BSL)-4 facilities.
The event will be hosted at the National Ebola Training and Education Center in Omaha, Nebraska.
This 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.
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).
Please visit the FDA website Achieving Data Quality and Integrity in Clinical Trials Involving High-Consequence Pathogens for more information and UTMB’s Registration Page.