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.
Language Availability: English
Suggested Audiences: Clinical Investigators, Faculty, Researchers, Staff, Students
Organizational Subscription Price: $675 per year/per site for government and non-profit organizations; $750 per year/per site for for-profit organizations
Independent Learner Price: $99 per person