Achieving Data Quality and Integrity in Clinical Trials Involving High Consequence Pathogens
The U.S. Dept. of Health and Human Services Food and Drug Administration (FDA) Office of Counterterrorism and Emerging Threats (OCET), the University of Texas Medical Branch at Galveston (UTMB), and the National Ebola Training and Education Center (NETEC) are recruiting participants to attend a two and one half day pilot training course focusing on the preparation and execution of research clinical trials to facilitate the approval of medical countermeasures for high consequence pathogens.
Location: Virtual/University of Nebraska Medical Center (UNMC), Omaha, Nebraska. Note: We will follow government regulations regarding COVID-19; depending on the outcome of the pandemic, an alternative contingency plan will be communicated.
August 31st-September 3rd; Rescheduled for October 26th-30th
Course Fees: There are no registration fees associated with this course
Outcome: The goal of this unique educational course is to provide a learning environment that promotes collaboration of ideas, provides tools for clinical study conduct, enhances mutual understanding of clinical, scientific and regulatory complexities, and promotes the data quality and integrity derived from these regulated studies. 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.
Target Audience: Physicians, Scientists, Principal Investigators, Physician Assistants, Nurse Practitioners, Nurses, Pharmacists, Clinical laboratorians, Clinical research staff, Regulators, Policy-makers, Regulatory reviewers, Biosafety professionals, IRB professionals, and Sponsors.
Faculty: Subject Matter Experts from, but not limited to, the FDA, NIH, BARDA, UNMC, and NETEC.
Overall Course Objectives
1. Formulate solutions to regulatory, operational, and cultural challenges for the conduct of clinical trials of medical countermeasures for high consequence pathogens 2. Identify and mitigate risks to data quality and integrity3. Resolve complexities of performing clinical trials in biocontainment / barrier nursing environment under GCP4. Experience conduct of clinical research tasks in a mock biocontainment environment while wearing high level PPE
Proposed 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
- Lessons Learned from Tranquil Terminus and Other Experiences
Pre-Registration Information (Required)
Registration for the 2020 course has officially closed. At that time, interested participants will be placed on the 2021 waiting list. Pending the outcome of COVID-19, course organizers will provide communication updates to all potential attendees. We will continue to monitor the pandemic and provide an alternative contingency plan as needed. The safety of our course participants is our priority; future plans for the commencement of this course will align with governmental regulations and guidelines. Thank you for your understanding in advance.
To express your interest in attending the 2021 course, please email the following information to firstname.lastname@example.org:
Once the above information has been received, you will be contacted with additional information.
- First / Last name
- Degree(s) held
- Research Clinical Trial Experience (brief summary)
- Contact Information
- Name of person(s) or organization that referred you to the course
Thank you for your interest in participating in this training course.