The Audit in the Clinical Trial

Abstract

Independent and methodological review of clinical research activities and documents to determine whether the activities related to the establishment and monitoring of this clinical research were conducted, if the data were collected, analyzed and reported in compliance with the protocol, standardized operating procedures. System audits should be of a reasonable size and easily manageable with the resources provided (can be managed). Audits must be organized and conducted in such a way that they generate in acceptable results. Most importantly, do not downgrade your audit program, leave windows for nonprogrammed audits.