November 2024 SOCRA Source Journal - Journal - Page 89
SOCRA Clinical Site Coordinator/Manager Workshops
GCP For Site Coordinators, Research Associates, Study Nurses, Site Managers
NOVEMBER 14 & 15, 2024 | DENVER, CO
APRIL 10 & 11, 2025 | VIRTUAL
IN-PERSON
VIRTUAL
In-person Workshop Registration Fee: $615 (Non-member $690 - includes one year's membership)
Virtual Workshop Registration Fee: $425 (Non-member $500 - includes one year’s membership)
Objective: This interactive virtual workshop will be accomplished through lecture and practical application facilitated
by clinical research professionals with a combined industry experience of more than 20 years. Information will be
presented and discussed regarding administration of clinical trials according to FDA Regulations and International
Conference on Harmonisation (ICH) guidelines as well as practical procedures and site / sponsor / CRO relationships.
Goal: The Society of Clinical Research Associates (SOCRA) recognizes the continuing need for education for Clinical
Research Professionals responsible for the activities at the research site or institution. The purpose of this workshop
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 Conference on 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 de昀椀nitions 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 (in-person) or 12.0 (virtual)
Continuing Education Credits for SOCRA CE, Nurse CNE, and Physician CME.
SOCRA designates this live activity for a maximum of 13.25 (in-person) or 12.0 (virtual) 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
SOCRA SOURCE © November 2024
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