Clinical Trials Overview: Methodology and Practice (GSND-N5310-001)
This course is designed to teach researchers at all levels (investigator, study coordinator, study monitor, study staff) the fundamentals of a good clinical trial in the evaluation of a new drug or device, be it industry, federal or philanthropic sponsored. Whether the ultimate purpose is to create a clinical protocol, or to carry out or monitor a protocol, understanding the options and reasons for a clinical trial design impacts the daily conduct and success of the trial. Discussion starts with the evaluation process leading up to human volunteer trials, through elements in designing a trial, writing the scientific protocol, considering regulatory issues and human subjects protection, through elements in protocol development/implementation, and quality assurance.
David L. Hom, M.S.
Assistant Professor
Department of Primary Care
School of Health Related Professions - UMDNJ
Assistant Professor of Medicine
Center for Emerging Pathogens/Division of Infectious Diseases
ADMC Bldg 6, Suite 614
New Jersey Medical School - UMDNJ
973.972.8699; homdl@umdnj.edu
Carlotta Rodriguez, BS, CIP
Director, Newark Campus Institutional Review Board
University of Medicine & Dentistry of New Jersey.
Norman Lasser, M.D., Ph.D.
Professor of Medicine/Director, Preventive Cardiology Program,
Department of Medicine – NJMS.
Carolyn Rogers, BSN, RN, CCRC
Research Nurse – Department of Neurosurgery, NJMS.
Snow Day Information
Call For Weather Related Information - 973-972-4700
Announcements are on the website for the University and on the radio at
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