November 2024 SOCRA Source Journal - Journal - Page 95
SOCRA Clinical Research Monitoring and GCP Virtual Conference
for Monitors, Site Coordinators and Auditors
FEBRUARY 11 TO 14, 2025 I VIRTUAL
MAY 20 TO 23, 2025 I VIRTUAL
OCTOBER 21 TO 24, 2025 I VIRTUAL
VIRTUAL
Workshop registration fee: $435 (Non-member $510 - includes one year’s membership)
Goal: The Society of Clinical Research Associates (SOCRA) recognizes the continuing need for education for Clinical Research
Professionals. Clinical Research Monitoring is an evolving practice. The purpose of this workshop is to assist Research Site
Coordinators, Quality Assurance Auditors, and CRAs/Monitors in improving their skills and their understanding of the roles and
responsibilities of the Clinical Research Associate/Monitor. Although designed with all research professionals in mind, this program
is ideal for Research Study Coordinators who want to improve the understanding of their responsibilities and interactions with
their Clinical Research Monitors, and for Monitors/Auditors/Project Managers with 0-5 years monitoring experience who want to
increase their knowledge and understanding of monitoring responsibilities.
Objective: The goal 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 monitoring
clinical trials according to FDA Regulations and International Conference for Harmonisation (ICH) guidelines as well as practical
procedures and site/sponsor/CRO relationships.
Learning Objectives - The attendee should be able to:
• Describe the role of monitoring in clinical research
• Discuss the basic principles of Good Clinical Practice; International Conference on Harmonisation GCP guidance; Investigator’s
responsibilities; Sponsor’s responsibilities; Monitor’s responsibilities; record retention; and basic requirements for conducting
studies in Canada
• Describe the investigator recruitment process, identify key selection criteria, and discuss the conduct of a site selection visit
• Within the historical perspective of the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report, discuss the
objectives of regulations pertaining to Institutional Review Boards and 昀椀nancial disclosure
• Discuss regulatory requirements and ethical considerations involved in the informed consent process as well as the informed
consent document
• Describe the activities involved in study initiation including budget and contract negotiation; planning and conducting
investigator meetings; investigator selection; the conduct of study initiation visits; and preparing the site for study participation
• Assess the collection and evaluation of research data for completeness, compliance, and accuracy through periodic monitoring
visits; discuss reporting and follow-up correspondence
• Compare and contrast the auditing and monitoring functions; describe the objectives of auditing; describe FDA inspections
and how to prepare for them; review FDA warning letters
• Discuss mechanisms to implement and assure the quality of the processes and deliverables involved in clinical research
• Describe the essential elements of planning and preparing for and conducting a site closeout visit; site follow-up; and 昀椀nal
documents for closure
• Describe site management techniques to manage expectations, facilitate site interactions, and improve subject recruitment
and study conduct
• Discuss additional investigator responsibilities and monitoring of investigator-initiated studies
SOCRA designates this educational activity for a maximum of 15.0 Continuing Education Credits
for SOCRA CE, Nurse CNE, and Physician CME.
SOCRA designates this live activity for a maximum of 15.0 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 200
SOCRA SOURCE © November 2024
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