August 2024 SOCRA Source Journal - Journal - Page 99
SOCRA Clinical Site Coordinator/Manager Workshop
GCP For Site Coordinators, Research Associates, Study Nurses, Site Managers
NOVEMBER 14 & 15, 2024 | DENVER, CO
INPERSON
Workshop registration fee: $615 (Non-member $690 - includes one year9s membership)
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
fuloll these duties proociently. Speciocally 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 proocient 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 - 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 deonitions 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 (SOPs)
SOCRA designates this educational activity for a maximum of 13.25 Continuing Education Credits
for SOCRA CE, Nurse CNE, and Physician CME.
SOCRA designates this live activity for a maximum of 13.25 AMA PRA Category 1 Credit(s)#.
Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CME for Physicians: The Society of Clinical Research Associates is accredited by the Accreditation Council for
Continuing Medical Education to provide continuing medical education for physicians.
CNE for Nurses: Society of Clinical Research Associates is accredited as a provider of continuing nursing education
by the American Nurses Credentialing Center's Commission on Accreditation.
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