Events

SEMINAR DESCRIPTION

In preparation for the conduct of a clinical trial, investigators must plan for the management of medications used as an intervention or a supportive drug. In setting up for a study, there are various aspects to consider for implementation, tracking, and quality assurance. This one-hour seminar will discuss drug management planning and implementation considerations for trials in the CTN.

LEARNING OBJECTIVES

• Describe drug management planning and preparation activities.
• Discuss tools for drug inventory and drug accountability tracking.
• Define implementation challenges and quality assurance.

TARGET AUDIENCE

Everyone is welcome! This session is targeted to research staff with responsibilities for drug management planning and implementation in clinical trials.

About the Presenters

Patricia Novo, MPA, MPH
Patricia “Patsy” Novo is an Assistant Research Scientist in the Department of Psychiatry at NYU’s School of Medicine where she is responsible for project planning and resource allocation for clinical trials in mental health and addiction. Patsy has been part of the CTN since its earliest days and is currently the National Project Manager for the CTN-0051 study. Prior to joining the staff at NYU, she provided technical assistance to non-profit organizations, planned projects to improve women’s health in developing countries, and was part of the founding team of Action Without Borders/idealist.org, among other work activities. Patsy has a BS degree from Cornell University, an MPA in Management from the Wagner School of Public Service at NYU, and a Master’s degree in Global Public Health from NYU.

Beth Jeffries, BS, CCRP
Beth Jeffries is a Protocol Monitor for the National Drug Abuse Treatment Clinical Trials Network (NDAT CTN) Clinical Coordinating Center at The Emmes Corporation. Since 2008, she has been providing Quality Assurance (QA) support on numerous CTN drug and non-drug studies, with responsibilities for monitoring and reporting, providing guidance and training to site staff on protocol adherence, regulatory, safety, and other site/study specific concerns as well as providing study set-up and implementation support services. Previously, Beth worked as a clinical research associate, research program coordinator, and laboratory technician with the National Cancer Institute and other research organizations. Beth obtained a BS degree in Biology from Bennett College, and she is CCRP certified by the Society of Clinical Research Associates (SOCRA).