Controlled Substances in Clinical Research Settings

This module explores the oversight of controlled substances, which are tightly regulated due to their abuse and dependence potential. In the U.S., federal laws and regulations set forth how federal oversight and enforcement mechanisms control the life cycle of these substances. Each state also establishes its own rules and regulations on various uses and users of controlled substances. This module introduces the regulatory framework for the use of controlled substances in the U.S. More specifically, it reviews U.S. laws and regulations; the controlled substance schedules; the federal and state authorities responsible for enforcement; federal and state authorizations associated with the manufacturing, distribution, storage, dispensing, and use of controlled substances; and schedule-based requirements.

Recommended Use: Required
ID (Language): 20716 (English)
Author(s): Ji-Eun Kim, PhD, RPh, RAC - Northwell Health

There is inherent risk to the use of controlled substances and chemicals in research. To limit the risks, it is imperative that researchers are aware of the abuse and diversion potential of the products they will use in their studies. All aspects of the research apparatus are responsible for mitigating these risks, including individual researchers and staff, internal and external oversight bodies, and institutional leadership. This module provides an overview of the differences between controlled substances, precursor chemicals, and controlled chemicals as well as the pharmacological properties and medical uses of controlled substances. Learners will also review how controlled substances are abused and relate this to theft, loss, and diversion. The module concludes with a review of institutional governance (such as review committees or oversight bodies) that monitor and evaluate the use of controlled substances and how to mitigate and prevent a theft, loss, or diversion. 

Recommended Use: Required
ID (Language): 20717 (English)
Author(s): Melissa A. Scotti, PhD, CIP - Northwell Health

Controlled substances can be highly dangerous and addictive. For this reason, it is important to have controls in place to prevent theft and the diversion of controlled substances. The U.S. Drug Enforcement Agency (DEA) regulations provide specific security requirements for the storage of controlled substances. The DEA also evaluates the security of systems to determine compliance with its regulatory requirements. There may be additional requirements through state law, local institutional/facility policy, and research sponsors. This module focuses on the requirements for storage, procurement, delegation, and final disposition. The Management of Controlled Substances – Part 2 (Documentation and Maintaining Compliance) module explores the documentation requirements for maintaining compliance and reporting requirements for loss, theft, or diversion of controlled substances.

Recommended Use: Required
ID (Language): 20718 (English)
Author(s): Melissa Naraine, MA, CCRC - Northwell Health; Stephen Frattini, DVM - Northwell Health

As part of a robust plan to manage controlled substances, facilities should develop appropriate procedures for documentation and recordkeeping to effectively track the life cycle of controlled substances. This includes retaining and maintaining all required documents associated with controlled substance transactions and establishing a monitoring system to evaluate and reconcile inventory. This module explores the regulatory requirements for documentation and covers the reporting requirements for the loss, theft, or diversion of controlled substances.

Recommended Use: Required
ID (Language): 20719 (English)
Author(s): Melissa Naraine, MA, CCRC - Northwell Health

Federal and state regulations are heavily focused on preventing inappropriate access to and diversion of controlled substances. Audits and inspections of an organization’s controlled substance program are important not only to verify compliance with the regulations, but to ensure public safety and security. Diversion of controlled substances from appropriate clinical research use can result in detrimental and even deadly consequences. This module discusses how a well planned and executed program, including internal and external audits and inspections, can decrease the organization’s risk of diversion.

Recommended Use: Required
ID (Language): 20720 (English)
Author(s): Stephen Frattini, DVM - Northwell Health; Hamangi Patel, LMSW, CHRC, RQAP-GCP, CCRP - Northwell Health