GCP for Coordinators, Research Associates, Study Nurses, and Site Managers
Goal: The Society of Clinical Research Associates (SOCRA) acknowledges the ongoing necessity for continuous education among Clinical Research Professionals who bear the responsibility for research activities at their respective sites or institutions. The primary aim of this program is to support clinical research professionals in enhancing their comprehension of the site's responsibilities and equipping them with practical skills and effective strategies to fulfill these duties proficiently. Specifically tailored to the principles of Good Clinical Practices (GCP) outlined in the U.S. Code of Federal Regulations and the guidelines endorsed by the International Council on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH Guidelines), this program focuses on addressing the core functions of research sites in clinical trials.
Objective: This workshop combines comprehensive lectures and hands-on practical applications led by experienced clinical research faculty. Participants will engage in in-depth discussions and learn about the proficient management of clinical trials in accordance with FDA Regulations and International Council on Harmonization (ICH) guidelines. Additionally, the workshop will cover practical procedures and foster a deeper understanding of the dynamics among sites, sponsors, and Contract Research Organizations (CROs) involved in clinical research.
Learning Objectives: Upon completion of this course the attendee should be able to: