GCP for Coordinators, Research Associates, Study Nurses, and Site Managers
8:30 to 9:00 AM - Welcome
9:00 to 10:15 AM - Foundations of Research (1.25 CE)
Clinical trials are governed by regulations and guidelines of various agencies. This session will review the historic events which lead to the development of current research regulations and guidelines as well as discussing the basic philosophy and guiding principles of clinical research and Good Clinical Practice (GCP).
10:15 to 11:15 AM - Roles of Site Professionals (1 CE)
Good Clinical Practices outline the roles and responsibilities of clinical site personnel. This session will focus on the Investigator responsibilities as defined in GCP guidelines and the practical considerations and implementation at the research site. In compliance with GCP, this session will include training requirements for research staff, resources allocation, and responsibilities of maintaining study product.
11:15 to 11:30 AM - Break
11:30 AM to 12:30 PM - The Protocol (1.0 CE)
The study protocol review is often the first interaction with the site and the sponsor. This session will consider site selection and feasibility, site requirements, as specified in the protocol, and subject availability. Using an example protocol, attendees will have experience analyzing the protocol to make important site-specific decisions.
12:30 to 1:15 PM - Lunch
1:15 to 2:15 PM - Safety of the Research Subject (1.0 CE)
It is incumbent upon the investigator to protect the safety of the research participant and this module will review the various aspects of human research protections. Course leaders review the ICH definitions of AEs (adverse events) and SAEs (serious adverse events) and describe the common reporting requirements. Participants also review unexpected adverse drug reactions and the appropriate procedures for informing IRBs/IECs and regulatory agencies.
2:15 to 2:30 PM - Break
2:30 to 3:30 PM - Leadership and Team Dynamics (1.0 CE)
The management of the research team often is the responsibility of the Site Coordinator. This session will focus on coordinator empowerment, management of team organization and training, and compliance with GCP. Adult learning strategies, leadership fundamentals and team building techniques will be discussed and practiced.
3:30 to 4:00 PM - Lessons Learned Day 1 (0.5 CE)
Reflection on the day and discussion of the integration of GCP in the topics covered in the Site Coordination Day 1 sessions.
9:00 to 10:30 AM - Informed Consent Process (1.5 CE)
The Informed Consent Process (ICF) will be discussed in relation to applicable regulatory requirements and GCP. Course leaders and participants will discuss specific elements required for both the informed consent document and the informed consent process. The session will provide an opportunity for individuals to ask questions regarding unique circumstances at their research sites. This session will look at ALCOAC documentation standards in compliance with GCP.
10:30 to 10:45 AM - Break
10:45 to 11:45 AM - Monitoring Visits (1.0 CE)
High quality clinical research is an essential component of the development of new medical treatments. Participants will discuss the rationale and issues surrounding the monitoring visit from a site, a sponsor, and a regulatory perspective. Course leaders provide tips to help participants prepare for a successful relationship with a study monitor.
11:45 AM to 12:45 PM - Audits and Inspections (1.0 CE)
This module will consider the essence of the audit and the inspection. Discussion will include a review of the purpose of an audit; the documents, policies and procedures open to audit; the mechanisms of audit; various outcomes; and the site’s opportunities to respond. Course leaders provide tips to help site personnel prepare for an audit or inspection.
12:45 to 1:30 PM - Lunch
1:30 to 2:30 PM - Continuous Quality Improvement (1.0 CE)
In this session, the participants will discuss responses to inspection findings and the current trend of regulators and sponsors to request Corrective Action Plans (CAPA) and Standard Operating Procedures (SOPs). This session will use case studies to illustration session topics.
2:30 to 2:45 PM - Break
2:45 to 3:45 - GCP and Site Responsibilities (1.0 CE)
GCP concepts are complex and integrated throughout the Site Coordinator role. This session will review the GCP responsibilities and application for the Site Coordinator. This session will demonstrate the integration of GCP in the work of a Site Coordinator.
3:45 to 4:00 PM - Lessons Learned - Day 2 (0.25 CE)
Reflection on the day with discussion of the integration of GCP in the topics covered in the Site Coordination workshop.