Clinical Site Coordinator / Manager and GCP Virtual Workshop

*All times are in Eastern Time Zone

Day 1

12:00 to 1:00 pm ET            The Regulatory Environment (1 CE)

All aspects of clinical trials are governed by various regulations and guidelines. This session will review the development of current regulations and guidelines as well as discussing the basic philosophy and guiding principles of clinical research GCP

1:00 to 1:15 pm ET             Break

1:15 to 2:45 pm ET             Good Clinical Practice at the Research Site (1.5 CE)

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.  This session will focus on the Investigator Responsibilities as defined in GCP Guidelines and the practical considerations and implementation at the research site.

2:45 to 3:00 pm ET             Break

3:00 to 4:15 pm ET             Informed Consent Process (1.25 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 opportunity for individuals to ask questions regarding unique circumstances at their research sites. 

Day 2

12:00 to 1:00 pm ET        Study Implementation – Part 1 (1.0 CE)

This module will review characteristics and qualities of successful research sites and strategies for implementing these elements.

1:00 to 1:15 pm ET             Break

1:15 to 2:45 pm ET              Study Implementation – Part 2 (1.5 CE)

This module will discuss considerations and activities for preparation and implementation of new studies as well as good documentation practices.

2:45 to 3:00 pm ET              Break

3:00 to 4:15 pm ET             Safety for the Research Subject (1.25 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.

Day 3

 12:00 to 1:30 pm ET           Monitoring Visits (1.5 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.

1:30 to 1:45 pm ET             Break

1:45 to 2:45 pm ET              Audits and Inspections (1 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.

2:45 to 3:00 pm ET             Break

3:00 to 4:15 pm ET             Continuous Quality Improvement (1.25 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).