GCP for Coordinators, Research Associates, Study Nurses, and Site Managers
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 clinical research professionals in improving their understanding of the clinical research site responsibilities and apply skills and strategies to execute these responsibilities. This program is designed to address the functions of the research site related to the Good Clinical Practices (GCP) as delineated by the U.S. Code of Federal Regulations and the guidelines supported by the International Council on Harmonization 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 clinical research professionals with a combined industry experience of more than 30 years. Information will be presented and discussed regarding administration of clinical trials according to FDA Regulations and International Council on Harmonization (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: