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

Course Format

In-person (at UNMC) or Virtual

Course Fees

There are no fees associated with course attendance; however, seating for in-person attendance is limited and interested participants will be placed on a wait-list once seats are filled. Travel expenses and meals are incurred at the individual’s expense. Refer to hotel information below.

Course Pre-registration

Whether requesting to attend the course in-person or virtually, course registration is a 3-step process. The first step is to pre-register for the course to indicate your interest in attending. After completing the pre-registration form, you will receive an email with a second link where you will complete a short survey that gathers information on your knowledge and experience. Notification of course admittance will follow, and step 3 is your confirmation of attendance.

2024 Planned Course TopicsDays and Titles are Subject to Change

Course Faculty

The Clinical Course faculty include clinicians, nurses, biosafety officers, government leaders, and federal agency representatives with field experience from the US Department of Health and Human Services Food and Drug Administration (FDA), National Institutes of Health (NIH), Biomedical Advanced Research and Development Authority (BARDA), United States Department of Agriculture (USDA), University of Nebraska Medical Center (UNMC), University of Texas Medical Branch (UTMB), and Emory University.

Prerequisite Knowledge

A basic understanding of the Good Clinical Practice (GCP) is highly recommended. To meet this need, access to a free online course will be provided to course attendees.

• Basic GCP — This interactive modular online course is designed to provide an overview of Good Clinical Practice (GCP). Content summarizes the basic elements of GCP. For the novice, this online course provides a good introduction of the topic; for those with prior knowledge of GCP, this course provides a refresher of the ethical and quality standards described in GCP. This course focuses on GCP regarding the conduct of clinical research studies involving the investigation of drugs and biologics.

Course Certification, Learning Objectives, and Learning Outcomes

Continuing Education: This course is submitted for Continuing Education credits for nurses and quality assurance professionals. Details will be posted closer to course dates.

Course Learning 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 integrity.
3. Resolve complexities of performing clinical trials in biocontainment / barrier nursing environment under GCP.
4. Experience the conduct of clinical research tasks in a mock biocontainment / barrier nursing environment while wearing high level PPE (in-person attendees only).

Course Learning Outcomes

1. Utilize best practices for the design and implementation of research clinical trials during an outbreak involving high consequence pathogens.
2. Recognize and prevent potential risks to data quality and integrity.
3. Apply the GCP principles to research clinical studies of medical countermeasures for high consequence pathogens.
4. Mitigate data collection challenges in a biocontainment / barrier environment.

Course Location

The course will take place at the University of Nebraska Medical Center (UNMC)  located in Omaha, Nebraska. The in-person activities on Day 3 will take place at the Training, Simulation, and Quarantine Center located in the Global Center for Health Security at the Davis Global Center.  

UNMC Global Center for Health Security
985551 Nebraska Medical Center
Omaha, Nebraska 68198 - 5551
USA

The Training, Simulation, and Quarantine Center (TSQC) provides a 6-bed high-fidelity simulated biocontainment unit training center, emergency operations center, laboratory, multipurpose room for incident management and skills training, and is the only federally-funded, 20-bed National Quarantine Unit (NQU) in the United States. To learn more about the TSQC and NQU, click here.