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 research professionals in understanding, developing and implementing quality management systems (QMS) in the conduct of clinical trials. This conference provides attendees with new information, tools, and real life examples to help participants navigate the components of quality management in clinical research - quality planning, quality control, quality assurance, and quality improvement.
Objective: The goal will be accomplished through lecture and practical application facilitated by clinical research professionals. Information will be presented and discussed regarding the development and implementation of quality management systems in the conduct of clinical trials according to FDA Regulations and International Council on Harmonisation (ICH) guidance.
Learning Objectives: Upon completion of this (full) course the attendee should be able to: