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

2023 course dates to be announced. Please check back later for more information!

Course Description:

This two and one half-day 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).

Prerequisite Knowledge:

A basic understanding of Good Clinical Practices is highly recommended. To meet this need, access to a free online course will be provided to course attendees:

  • Basic GCP Training -- This self-pace module on-line course is designed to provide attendees with a general understanding of good clinical practices when conducting, or participating in, clinical research trials.

Credits awarded: This course is submitted for Continuing Education credits for physicians, nurses, and quality assurance professionals. Details are posted closer to course dates.

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, Sponsors, and sponsor monitors.

Course Fees: There is no cost to attend, but seating is limited and pre-registration is required. Note that course attendees are invited based upon diversity of roles, responsibilities, and organization. Interested participants will be placed on a waitlist once seats are filled.

Location: The University of Nebraska Medical Center, Omaha NE, USA

Overall 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 conduct of clinical research tasks in a mock biocontainment environment while wearing high level PPE

Overall Course Learning Outcomes:

  1. Develop 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. Application of the GCP principles to research clinical studies of medical countermeasures for high consequence pathogens.
  4. Better understanding of the clinical, research, and regulatory community on the challenges of data collection in a biocontainment/barrier environment.

Course Curriculum:

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

Course History:

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

Continuing Medical Education

The University of Texas Medical Branch is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

The University of Texas Medical Branch designates this Enduring material for a maximum of 17.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Continuing Nursing Education

Cizik School of Nursing at UTHealth is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center’s Commission on Accreditation.

This activity provides a maximum of 17.25 contact hours of continuing professional development hours.

Nursing contact hours will be awarded for successful completion of program components based upon documented attendance and completion of evaluation materials.   

RQAP Re-registration

In Person Attendees

“UTMB, Achieving Data Quality and Integrity in Maximum Containment Laboratories” course has been approved by the Society of Quality Assurance Council on Professional Registration for 17.25 GCP/non-GLP RQAP re-registration units.

Virtual Attendees

“UTMB, Achieving Data Quality and Integrity in Maximum Containment Laboratories” course has been approved by the Society of Quality Assurance Council on Professional Registration for 14.25 GCP/non-GLP RQAP re-registration units.

RAC Approval for Recertification Credits (Regulatory Affairs Professionals Society)

This course may be eligible to submit for RAC renewal.  Please refer to the RAC recertification guide for more information: https://www.raps.org/RAPS/media/RAC-Credential/Resources/2020-08-RAC-Recertification-Guide.pdf.Programs related to the scope of regulatory practice as defined by the RAPS competency model and/or the RAC content outlines that meet the RAC recertification requirements are eligible to earn RAC recertification credits. A full day program may qualify for 6 credits per day. There is a 12-credit maximum for a multiday event.  This event may qualify for 12 RAC credits.