Managing Controlled Substances in Research
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Webinar
Navigating the controlled substance regulations at the state and federal level can be challenging in research. Controlled substance usage can vary based on the type of research being conducted, the volume of controlled substance usage, and variety of drug schedules in use. Commonly, it is up to institutional compliance programs to interpret the regulations, set internal policies, and ensure that DEA registrants are meeting regulatory requirements at the institutional, state, and federal level.
In this webinar, attendees will learn important information, tools, and best practices to help establish and manage their own research controlled substance compliance programs, including:
- Brief introduction to controlled substances and the federal controlled substance regulations governing their use in research
- Controlled substance security and management in research areas
- Controlled substance recordkeeping requirements in research
- Establishing institutional oversight
- Preparing for state or DEA audits
Participants will take part in exercises on how to conduct a security analysis, investigate potential drug diversion, and learn important lessons on the consequences of non-compliance with controlled substance regulations.
Presented by Speakers
Kelli Christman
Kelli Christman, MHA, has worked in healthcare and research compliance at the University of Michigan (U-M) for more than 18 years. She has a background in inpatient pharmacy services and experience working in the U-M Health System Research Pharmacy managing investigational drugs for more than 400 clinical trials, including controlled substances. She has been in her current role as the Program Manager for the U-M Research Controlled Substance Monitoring Program for more than three years and was the Controlled Substance Monitor for the program for seven years. She received her bachelor’s degree in healthcare administration from Ohio University and her master’s degree in health administration from Eastern Michigan University. Using her skills in communication, crisis management, record auditing, and pharmacy practices, she assists faculty and staff across all research areas at U-M with their controlled substance compliance at the institutional, state, and federal levels.
Josh West
Joshua West, BS, University of Michigan (U-M) Controlled Substances in Research Monitoring Program Monitor, has more than 17 years’ experience as a researcher and over 2 years of experience in research compliance at the University of Michigan. He received his bachelor’s degree in Anthropology-Zoology from the University of Michigan. His research expertise lies with human genetic research, cardiovascular and pancreatic disease, and most recently in opioid drug discovery which offered a great insight in regulations regarding controlled substances. With having knowledge of scientific studies, laboratory management, employee relations, and best research practices, he assists faculty and staff across all research areas at U-M with their controlled substance compliance at the institutional, state, and federal levels.