Training Course: Achieving Data Quality and Integrity in Clinical Trials Involving High-Consequence Pathogens
April 8 - 10, 2019
National Institutes of Health
Register by March 7, 2019.
There is no cost to attend, but seating is limited, and pre-registration is required. Learn more, including how to begin the registration process.
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 GLP requirements in 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.
This additional pilot course, new in 2019, focuses on the preparation and execution of research clinical trials to facilitate the approval of medical countermeasures for high-consequence pathogens.
The course curriculum includes:
- Addressing cultural and language barriers
- Ethical considerations for placebo-controlled studies
- Regulatory expectations
- Study monitoring
- Barrier nursing challenges
- Sample integrity
- Protocol development
- International issues
- Stakeholder roles and responsibilities
Attendees will also learn from integrated scenarios, case studies based on real-life experiences, and expert panels, along with lectures from subject matter experts from FDA, the National Institutes of Health, the National Ebola Training and Education Center (NETEC), and clinical biocontainment units (BCUs).