Achieving Data Quality and Integrity in Clinical Trials Involving High Consequence PathogensFDA-UTMB Collaborative Education Program

Summer 2024Check back soon for dates!

Course Description:

This two and one half-day (2 days for virtual attendees) interactive course allows participants to enhance knowledge and integrate practical considerations for the planning and operation of clinical research protocols involving medical countermeasures for high consequence pathogens. Course participants acquire knowledge through innovative learning platforms and problem-based scenarios that help identify and mitigate barriers to data quality and integrity in domestic and international barrier nursing environments.

Course faculty include clinicians, nurses, biosafety officers, government leaders, and federal agency representatives with field experience. Attendees will 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 National Emerging Special Pathogen Training and Education Center (NETEC), and clinical biocontainment units (BCUs).

Course Topics:

  • Challenges of Ebola Clinical Studies in an Epidemic Setting
  • A Survivor’s Story: Dual Citizenship at the Ebola Bedside
  • The Varied Roles of Human and Animal Efficacy Data in MCM Development for High Consequence Pathogens (HCPs)
  • Overview of GCP
  • Roles and Responsibilities of the IRB
  • Cultural/Language Barriers
  • Informed Consent/Patient Communication
  • Operationalizing a Protocol
  • Protocol Driven Data Collection vs. Clinical Data
  • Good Documentation Practices and reporting of Adverse Events
  • Sample Collection
  • Writing Effective OPS
  • Study Monitoring
  • Deviations vs. Regulatory Violations
  • PPE and Barrier Nursing Mock Scenarios
  • Regulatory Requirements: FDA Inspections / NIH Regulatory Requirements
  • Development and Implementation of Effective Training
  • Overview of MCM Development
  • International Issues
  • Case Studies and Lessons Learned

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 involving clinical trials in geographic locations where outbreaks caused by high-consequence pathogens are frequent.

Course History:

2023

October 4-6
Live, Virtual

2022

July 11-13
University of Nebraska Medical Center – Global Center for Health Security 
Omaha, NE, USA
Hybrid

2021

August 2-4, 2021
Live, Virtual

2020

October 26-28
Live, Virtual

2019 – Pilot Course

April 8-10, 2019
National Institutes of Health (NIH)
Bethesda, MD, USA