Clinical Site Coordinator / Manager and GCP Virtual Workshop
Goal: The Society of Clinical Research Associates (SOCRA) recognizes the continuing need for education for Clinical Research Professionals responsible for the activities at the research site or institution. The purpose of this program is to assist Site Coordinators, Research Associates, and Study Nurses in improving their skills and their understanding of the responsibilities of the Clinical Research Site. This program is designed to address all of the functions of the research site related to the Good Clinical Practices as delineated by the U.S. Code of Federal Regulations and the guidelines supported by the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH Guidelines).
Objective: The goal will be accomplished through lecture and practical application facilitated by a clinical research professional with industry expertise. Information will be presented and discussed regarding administration of clinical trials according to FDA Regulations and International Council on Harmonisation (ICH) guidelines as well as practical procedures and site / sponsor / CRO relationships.
Learning Objectives: Upon completion of this course the attendee should be able to:
- Discuss aspects of clinical trials that are governed by regulations and guidelines.
- Discuss the basic philosophy and guiding principles of clinical research GCP.
- Discuss the elements of the Informed Consent Form, the ethical principles originating in the Declaration of Helsinki, the various aspects of the informed consent process, and those special considerations that may impact the process.
- Describe the various aspects of human research protections including the ICH definitions of AEs (adverse events) and SAEs (serious adverse events) and describe the reporting requirements common to all sponsors and IRBs/IECs.
- Discuss the role of the Study Coordinator including: Submitting a protocol to the IRB; Setting up local procedures; Source documentation management and control; and Working relations with Sponsors.
- Discuss the rationale and issues surrounding the monitoring visit and the audit process from a site, a sponsor, and a regulatory perspective.
- Discuss the parameters, goals, and outcomes of audits and inspections.
- Discuss the philosophy and rationale for the development and implementation of Standard Operating Procedures.