August 2024 SOCRA Source Journal - Journal - Page 81
SOCRA Clinical Research Monitoring and GCP Virtual Conference
for Monitors, Site Coordinators and Auditors
MAY 20 TO 23, 2024 I VIRTUAL
Workshop registration fee: $435 (Non-member $510 - includes one year’s membership)
Clinical Research Monitoring is an evolving practice. The purpose of this 4-day 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.
This interactive virtual workshop will be facilitated by clinical research professionals with a wealth of industry experience.
Information will be presented and discussed regarding monitoring clinical trials according to FDA Regulations and
International Conference on 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 and Nurse CNE.
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 © May 2024
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