Clinical Site Coordinator / Manager and GCP Workshop
For a printable PDF agenda, click here.
8:00-8:15 Registration and Continental Breakfast (Provided)
8:15-9:30 The Regulatory Environment (9:15-9:30 Health Canada)
All aspects of clinical trials are governed by regulations and guidelines. This session will discuss the various regulatory agencies and their respective guidelines in terms of their impact on the clinical trial site.
9:30-12:00 Good Clinical Practice at the Research Site (Break 10:00-10:15)
This session will consider the basic philosophy and guiding principles of clinical research GCP. GCP is a standard for the conduct and performance of clinical trials that provides assurance that the data is credible and accurate and that the rights, integrity and confidentiality of trial subjects are protected.
12:00-12:30 Informed Consent Process
The elements of the Informed Consent Form (ICF) will be discussed in relation to applicable regulatory requirements. These requirements adhere to GCP and to the ethical principles originating in the Declaration of Helsinki. The participants will have the opportunity to identify specific elements of the ICF. Course leaders will also discuss various aspects of the informed consent process and those special considerations that may impact the process.
12:30-1:15 Lunch (Provided)
1:15-2:30 Informed Consent Process (Continued)
2:30-4:30 Safety for the Research Subject (Break 3:00-3:15)
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 reporting requirements common to all sponsors. Participants also review unexpected adverse drug reactions and the appropriate procedures for informing IRBs/IECs.
8:00-8:15 Continental Breakfast (Provided)
8:15-10:00 Study Implementation
This module reviews the role of the Study Coordinator. Course leaders discuss the following issues: submitting a protocol to the IRB; setting up local procedures; and source documentation management and control. Through use of a practical exercise, participants will have the opportunity to critique documentation of a simulated study.
10:00-10:15 Break and Opportunity for Discussion
10:15-11:30 Monitoring Exercise and Discussion
11:30-12:30 Monitoring Visits
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.
12:30-1:15 Lunch (Provided)
1:15-2:30 Audits and Inspections
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.
2:30-3:00 Continuous Quality Improvement
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).
3:00-3:15 Break and Opportunity for Discussion
3:15-4:30 Continuous Quality Improvement (Continued)
Using a group exercise, attendees will evaluate a case study and complete root cause analysis, develop a CAPA and corresponding SOP.