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ForwardAchieving Data Quality and Integrity in Clinical Trials Involving High Consequence Pathogens (Clinical)
Overview
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 good laboratory practice (GLP) requirements in biosafety level (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.
An additional clinical pilot course was introduced in 2019. This 2 1/2 day interactive pilot allowed participants to learn about clinical research protocols for high-consequence pathogens, and help identify and mitigate barriers to data quality and integrity in domestic and international barrier environments involving medical countermeasures.
Based on demand and participant feedback, the pilot course was an overwhelming success and is being expanded into a 4-day course consisting of classroom and practical hands-on instruction.
Target Audience
This activity is deigned for Physicians, Scientists, Principal Investigators, Physician Assistants, Nurse Practitioners, Nurses, Pharmacists, Clinical laboratorians, Clinical research staff, Regulators, Policymakers, Regulatory reviewers, Biosafety professionals, IRB professionals, and Sponsors.
Learning Objectives
At the conclusion of the session, the participants should be able to:
- Formulate solutions to regulatory, operational, and cultural challenges for the conduct of clinical trials of medical countermeasures for high consequence pathogens
- Identify and mitigate risks to data quality and integrity
- Resolve complexities of performing clinical trials in biocontainment/barrier nursing environment under “Good Clinical Practices"
- Conduct clinical research tasks in a mock biocontainment environment while wearing Personal Protective Equipment.
Kevin Barrett, B.S.N., R.N. - Planning Committee, Contributor
Clinical Research Specialist of National Institute, Allergy and Infectious Diseases
National Institutes of Health
Disclosure: Nothing to disclose
Charles Bonapace, Pharm.D. - Contributor
Director, Division of New Drug Study Intefrity
The United States Food and Drug Administration
Disclosure: Nothing to disclose
Ian Crozier, M.D. - Contributor
Medical Affairs Scientist
Frederick National Lab
National Institute of Allergy and Infectious Diseases
Disclosure: Nothing to disclose
Lorraine Terrell Davis, B.A. - Planning Committee
Training Specialist II
The University of Texas Medical Branch
Disclosure: Nothing to disclose
Lori E Dodd, Ph.D. - Contributor
Mathematical Statistician, Biostatistics Research Branch
National Institute of Allergy and Infectious Diseases
Disclosure: Nothing to disclose
Melissa Eitzen, M.S., R.Q.A.P.-G.L.P., M.T.(A.S.C.P.) - Activity Director
Director & Principal Investigator, Regulatory Operations
Institutional Office of Regulated Non-clinical Studies
The University of Texas Medical Branch
Disclosure: Nothing to disclose
Nina El-Badry, M.S. - Contributor
Regulatory Specialist
Department of Health and Human Services
Disclosure: Nothing to disclose
Vaunette Fay, Ph.D., R.N. - Planning Committee
Professor, Cizik School of Nursing
The University of Texas Health Science Center at Houston
Disclosure: Nothing to disclose
Bruce G Gordon, M.D. - Contributor
Professor
University of Nebraska Medical Center
Disclosure: Nothing to disclose
Robert Gump, B.S. C.M.A.R. - Planning Committee, Contributor
Biologist, Interdisciplinary Scientist
The United States Food and Drug Administration
Disclosure: Nothing to disclose
Aloysius Hanson, Ph.D. - Contributor
Clinical Public Health Director and Consultant
National Public Health Laboratory Ministry of Health and Social Welfare, Republic of Liberia
Disclosure: Nothing to disclose
Lisa Hensley, Ph.D. - Contributor
Associated Director of Science, Office of Chief Scientist
National Institutes of Health
Disclosure: Nothing to disclose
R.A.D.M., Estella Jones, D.V.M. - Planning Committee, Contributor
Deputy Director, Office of Counterterrorism and Emerging Threats
The United States Food and Drug Administration
Disclosure: Nothing to disclose
Mark Kortepeter, M.D. - Contributor
Vice President for Research
Uniformed Services University
Disclosure: Nothing to disclose
Colleen Kraft, M.D., M.S. - Contributor
Associate Chief Medical Officer
Emory University Hospital
Disclosure: Nothing to disclose
Chris Kratochvil, MD - Planning Committee, Contributor
Associate Vice Chancellor for Clinical Research
University of Nebraska Medical Center
Disclosure: Nothing to disclose
LuAnn Larson, B.S.N - Contributor
Director of Clinical Research Operations
University of Nebraska Medical Center
Disclosure: Nothing to disclose
CDR Christopher Le, M.S. - Contributor
Public Health Service Officer
The United States Food and Drug Administration
Disclosure: Nothing to disclose
CDR Thomas Maruna, M.Sc., M.A. - Planning Committee, Contributor
Senior Scientific Program Manager, Medical Countermeasures Initiative
The United States Food and Drug Administration
Disclosure: Nothing to disclose
Jayco McCowan, D.B.A. - Planning Committee
Training/Program Manager
The University of Texas Medical Branch
Disclosure: Nothing to disclose
Susan McLellan, M.D., M.P.H. - Contributor
Professor of Medicine
The University of Texas Medical Branch
Disclosure: Nothing to disclose
CDR Jeremy Peacock, R.N. - Contributor
Grant Project Officer
Substance Abuse and Mental Health Services Administration
Disclosure: Nothing to disclose
Rosemary Roberts, M.D. - Contributor
Director, Counter-Terrorism and Emergency Coordination Staff
The United States Food and Drug Administration
Disclosure: Nothing to disclose
Morgan Shradar, B.S.N. - Planning Committee, Contributor
Co-Director National Training Center
Davis Global Center
Disclosure: Nothing to disclose
CAPT Brianna Skinner, D.V.M., M.P.H. - Planning Committee, Contributor
Senior Regulatory Veterinarian, Veterinary Medicine
The United States Food and Drug Administration
Disclosure: Nothing to disclose
Mary Smolskis, R.N. - Contributor
Clinical Research Oversight Manager
National Institute of Allergy and Infectious Diseases
Disclosure: Nothing to disclose
Jovonni Spinner, Ph.D. - Contributor
Associate Director of Outreach and Communications
The United States Food and Drug Administration
Disclosure: Nothing to disclose
Susan E. Vogel, R.N. - Contributor
Clinical Research Oversight Manager
National Institute of Allergy and Infectious Diseases
Disclosure: Nothing to disclose
LCDR Michael D Wagner, M.S., C.N.P. - Contributor
Psychiatric Mental Health Nurse Practitioner
Commissioned Corps of the United States Public Health Service
Disclosure: Nothing to disclose
CDR Temeri Wilder-Kofie, D.V.M. - Contributor
Facility Veterinarian
National Institute of Allergy and Infectious Diseases
Disclosure: Nothing to disclose
LCDR Hanniebey Wiyor, Ph.D. - Contributor
Human Factors Regulatory Officer
The United States Food and Drug Administration
Disclosure: Nothing to disclose
Physicians
Baylor College of Medicine is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.
Baylor College of Medicine designates this live activity for a maximum of 14.50 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Nursing
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.
The Cizik School of Nursing at UTHealth designates this live activity for a maximum of 14.50 ANCC contact hours. Nursing contact hours will be awarded for successful completion of program components based upon documented attendance and completion of evaluation materials.
Available Credit
- 13.50 AMA PRA Category 1 Credit™
- 13.50 ANCC
- 13.50 Attendance