Program Description

Clinical Site Coordinator / Manager and GCP Workshop:

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:

• Discuss aspects of clinical trials that are governed by regulations and guidelines.
• Discuss the basic philosophy and guiding principles of clinical research GCP.
• Discuss the elements of the Informed Consent Form, the ethical principles originating in the Declaration of Helsinki, the various aspects of the informed consent process, and those special considerations that may impact the process.
• Describe the various aspects of human research protections including the ICH definitions of AEs (adverse events) and SAEs (serious adverse events) and describe the reporting requirements common to all sponsors and IRBs/IECs.
• Discuss the role of the Study Coordinator including: Submitting a protocol to the IRB; Setting up local procedures; Source documentation management and control; and Working relations with Sponsors.
• Discuss the rationale and issues surrounding the monitoring visit and the audit process from a site, a sponsor, and a regulatory perspective.
• Discuss the parameters, goals, and outcomes of audits and inspections.
• Discuss the philosophy and rationale for the development and implementation of Standard Operating Procedures.