Auditing in Clinical Research
GMS BT 360
Clinical research auditing ensures that the rights, safety, and well being of the study subject have been protected and the clinical study data are credible. Auditing clinical trial activities provides the strict oversight of performance with the ultimate goal of having a successful submission and identifying opportunities for improvement. In this practical course, students learn how to prepare and conduct audits, write audit observations, create an audit report and review audit report responses. In addition, students learn how to manage audits by an outside agency. Good Clinical Practice (GCP) guidelines and regulatory requirements are reviewed along with exploring the concept of a quality system and the writing of audit program Standard Operating Procedure (SOP). Developing an audit plan is emphasized. Group discussions and role- playing are used to develop practical audit techniques. This class prepares a student for an introductory auditing position within clinical research.