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 workshop is to assist Clinical Investigators and key research staff in improving their skills and their understanding of the responsibilities of the clinical research site. This program is intended to share information and create opportunity for dialogue among clinical investigators, key research staff and program faculty. The specific goal is to enhance the participants’ ability to perform quality clinical research according to existing regulations and guidelines. 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 clinical research professionals. Information will be presented and discussed regarding administration of clinical trials according to FDA Regulations and International Council for 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: