Program Description

Clinical Research Monitoring and GCP Virtual Workshop for Monitors, Site Coordinators and Auditors

Goal: The Society of Clinical Research Associates (SOCRA) recognizes the ongoing need for professional development in the ever-evolving field of clinical research. This workshop is designed to enhance the skills and knowledge of Research Site Coordinators, Quality Assurance Auditors, and Clinical Research Associates (CRAs)/Monitors. Participants will gain a deeper understanding of the roles and responsibilities of CRAs/Monitors and improve collaboration across research teams. While relevant to all clinical research professionals, this program is especially valuable for Research Study Coordinators looking to strengthen their interactions with CRAs, and for Monitors, Auditors, and Project Managers with 0-5 years of monitoring experience seeking to broaden their expertise.

Objective: This goal will be achieved through a combination of lectures and practical applications led by seasoned clinical research professionals. Participants will explore key topics, including clinical trial monitoring in accordance with FDA regulations and International Council for Harmonisation (ICH) guidelines, as well as practical procedures and the dynamics of site, sponsor, and CRO relationships.

Learning Objectives: Upon completion of the workshop, the attendee should be able to:

Describe the role of monitoring in clinical research
Discuss the basic principles of Good Clinical Practice; International Conference for 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 fi 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 final 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