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Best practices for study drug management and accountability throughout the study lifecycle in multi-site randomized controlled trials



Blumberg, Dikla; Novo, Patricia ; Jeffries, Beth; Yesko, Lauren; Matthews, Abigail G; Collins, Julia; Salazar, Dagmar; Jelstrom, Eve; Wright, Matthew; Kondapaka, Radhika

SCT Annual Meeting

Liverpool, UK


Trial Management & Research Coordination Data Management Choosing interventions

Managing study drug throughout a trial is a complex, vital task further compounded when there are multiple research sites participating. Adherence to good clinical practice (GCP) requirements and all applicable regulatory requirements is paramount. The National Drug Abuse Treatment Clinical Trials Network (CTN) Clinical Coordinating Center (CCC) and Data and Statistics Center (DSC), both at the Emmes Corporation, collaboratively developed a series of processes and tools, some of which are incorporated in the electronic data system, to ensure an efficient and controlled chain of custody and process beginning from initial supply distribution through dispensing procedures at the research sites and final reconciliation and destruction. The CCC and DSC consider several factors when determining the process for study drug management, including treatment blinding, drug type, quantity and packaging, frequency of distribution, expiration dating, and the number of sites. Based on these parameters, the CCC assists the study teams in development of clear and thorough drug management logs as well as defining drug storage and temperature monitoring requirements. To remedy last minute requests, supply hoarding, and waste at the sites, the coordinating centers have developed a centralized inventory tracking and reordering process to monitor drug supply and distribution. In this process, research staff report inventory weekly directly in the Electronic Data Capture (EDC) system, and the data is pulled into reports, which identify reorder needs based on thresholds and usage. Before shipping initial supplies to each site, all regulatory documents are collected and training is provided to research sites on the importance of drug accountability and consequences for participant safety if inaccurately reporting drug dosing and disposal. Site monitors review the drug logs, medication storage, and regulatory documentation throughout the trial (remotely or on-site) in order to identify and resolve any improper practices, discrepancies and errors. The Emmes Corporation has supported substance use treatment interventions implemented in the CTN for over 11 years, and throughout that time have developed best practices including using systematic, clear and precise processes for study drug procurement, distribution, and monitoring. Over 14 clinical trials across 105 clinical sites have involved study drug, including 4 double-blinded studies and 4 Investigational New Drugs and 6 studies using controlled substances. Effective communication between the CCC/DSC, central pharmacy, third-party vendors, research sites, and all other stakeholders allows for efficient planning and prompt resolution to problems that arise. Supporting this communication with real time data collection and reporting allows for the proper maintenance of a comprehensive and accurate study drug management system. This presentation will emphasize best practices for achieving an organized and controlled chain of custody throughout the life of a trial.

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