Individuals and organizations planning to handle, use, or study controlled substances in their research or other professional practices must understand the risks and regulatory responsibilities associated with employing these substances. They must comply with federal, state, and local requirements and establish best practices to prevent and mitigate those risks.
This in-depth course provides learners with an overview of the U.S. federal and select state laws and regulations that govern the use of controlled substances in clinical research, including the requirements for their acquisition, usage, storage, final disposition, and recordkeeping. It provides guidance for registrants/licensees and organizations on how to establish and maintain compliance with the controlled substances regulations. The course also reviews the mechanisms of action and abuse potential of controlled substances by pharmacological class. It further discusses considerations for the development of an effective program to prevent and mitigate diversion of controlled substances as well as guidance regarding how to prepare and respond to internal and external audits and inspections.
Clinical Investigators, Faculty, Researchers, Staff, Students
Meet the Authors
Ji-Eun Kim, PhD, RPh, RAC – Northwell Health
Ji-Eun Kim is a certified regulatory affairs professional with a PhD from MIT Biological Engineering and research pharmacy background. Prior to joining Northwell Health, she received postdoctoral trainings at MIT and Rockefeller University and worked in research pharmacy at the NYU Langone Medical Center and NYP Columbia University Medical Center.
Melissa Scotti, PhD, CIP – Northwell Health
Dr. Melissa A. Scotti received her PhD in Biology from Indiana University and after completing two postdoctoral fellowships transitioned to research compliance. Dr. Scotti’s experience includes positions with University of Colorado Health, Columbia University Medical Center, and Northwell Health. As a member of Northwell’s Office of Research Compliance she provides regulatory and QI/QA support to sponsor-investigators.
Melissa Naraine, MA, CCRC – Northwell Health
Melissa Naraine is a Compliance Manager at Northwell Health, one of New York’s largest healthcare provider. Melissa received her Bachelors and Masters degrees at the City University of New York.
Stephen Frattini, DVM – Northwell Health
Dr. Stephen Frattini is a veterinarian and senior program compliance manager in the Office of Research Compliance at Northwell Health. His current role is to lead the preclinical non-human subject compliance program at Northwell Health, including animal research, biosafety, and controlled substance management.
Hamangi Patel, LMSW, CHRC, RQAP-GCP, CCRP – Northwell Health
Hamangi Patel is the Director of The Office of Research Compliance at Northwell Health in New York. She leads the Audits and Investigations, the Conflicts of Interests and Global Compliance divisions. She over 15 years of experience in clinical research, research administration and research compliance, and has worked at multiple healthcare organizations on the East Coast and in the United Kingdom.