February 2024 SOCRA Source Journal - Journal - Page 90
SOCRA Clinical Site Coordinator / Manager Workshop
GCP For Site Coordinators, Research Associates, Study Nurses, Site Managers
JULY 12 TO 14, 2023
Registration Fees: Member: $425, Non-Member* $500
*includes one year membership
Objective: This interactive virtual workshop is designed to assist Site Coordinators, Research Associates, and Study
Nurses in improving their skills and their understanding of the responsibilities of the Clinical Research Site. This
program is will address all the functions of the research site related to the Good Clinical Practices as delineated by
the U.S. Code of Federal Regulations and the guidelines supported by the International Council for Harmonisation of
Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH Guidelines).
Goal: The purpose of this program is to assist Site Coordinators, Research Associates, and Study Nurses in
improving their skills and their understanding of the responsibilities of the Clinical Research Site. This program is
designed to address all of the functions of the research site related to the Good Clinical Practices as delineated by
the U.S. Code of Federal Regulations and the guidelines supported by the International Council for Harmonisation
of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH Guidelines).
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 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.
SOCRA designates this educational activity for a maximum of 11.25 Continuing Education Credits for SOCRA CE,
Nurse CNE, and Physician CME.
SOCRA designates this live activity for a maximum of 11.25 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.
SOCRA Course Series 600
90
SOCRA SOURCE © May 2023