Investigational agents are often classified as high-risk or hazardous medications, making their management crucial for the success and safety of clinical trials. Sites conducting studies involving these medications must establish clear, robust policies and procedures to ensure the proper handling of investigational products. One of the most effective ways to achieve this is through the implementation of Standard Operating Procedures (SOPs).
An SOP is a set of detailed instructions designed to guide staff through routine tasks, ensuring consistency, efficiency, and adherence to regulatory standards. The primary goal of SOPs is to minimize miscommunication and non-compliance, while providing a reliable reference for staff. For new employees, SOPs serve as a useful tool for learning processes, reducing the need to interrupt supervisors for guidance.
Leading organizations such as the American Society of Health-System Pharmacists (ASHP) and the Hematology/Oncology Pharmacy Association (HOPA) provide recommendations on the SOPs that sites should adopt to maintain compliance and consistency across clinical trials.
Key SOPs for Managing Investigational Medications
1. Inventory Control, Storage, and Handling
Sites must establish a policy to ensure proper inventory management, storage, and handling of investigational medications. This includes tracking expiration dates and managing product returns, as well as ensuring that investigational products are stored in secure areas separate from non-investigational medications. It’s essential to review each investigational agent to determine its unique storage, preparation, dispensing, disposal, and transportation requirements before beginning the study.
2. Drug Accountability and Documentation
A clear policy should be in place for documenting and maintaining drug accountability records (DARFs). While paper records can be used, an electronic inventory system is recommended to ensure compliance with FDA guidelines, including 21 CFR Part 11. This system should allow for real-time updates and ensure the accuracy of records.
3. Temperature Monitoring
Continuous, 24/7 temperature monitoring of investigational medications is essential to ensure proper storage conditions, even at remote or satellite locations. Temperature monitoring can be accomplished through various methods, such as minimum/maximum thermometers or automated systems that alert staff when temperatures go out of range. In the event of a temperature excursion, investigational medications must be quarantined and the study sponsor notified before they can be used.
4. Audits and Compliance
Regular audits are essential to verify that the study is being conducted according to federal, state, and sponsor requirements. Audits should review documentation such as DARFs, shipment records, destruction and return forms, storage records, and expiration dates.
5. Software and Electronic Systems
If computer software is used to manage investigational medications, it must comply with FDA’s 21 CFR Part 11 guidelines. Institutions should evaluate the software and implement a downtime procedure in case the system becomes unavailable.
6. Fees
Sites should establish a policy outlining the fees associated with each protocol, including costs related to setup, maintenance, personnel, preparation, and distribution of investigational products. Additionally, it’s important to set expectations for sponsor visits and ensure that sponsors review SOPs during the site initiation visit.
7. Sponsor Visits
Sites should establish a policy outlining what is expected from the monitors during their visits. Sites should provide all SOP’s and ensure the sponsor has reviewed them during the site initiation visit.
8. Study Closeout Procedures
A study closeout policy should address the proper handling of unused investigational products, final accountability records, and the destruction or return of medications. Maintenance of study records should also be outlined to ensure proper documentation is preserved.
Additional Considerations
Depending on the study, additional policies may be needed, such as coordinating treatments across multiple sites, shipping investigational products, and allowing the use of investigational products from other institutions.
Conclusion
Managing investigational agents requires meticulous planning and adherence to established protocols. By developing clear policies and SOPs, institutions can ensure the safe, efficient, and compliant handling of high-risk medications. Not only do SOPs promote consistency and regulatory compliance, but they also serve as invaluable tools for guiding staff through routine operations, minimizing errors, and enhancing operational efficiency. Ultimately, well-defined SOPs are essential for the successful execution of clinical trials and the safety of both patients and research teams.
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