A Quality Assurance Program for Sponsored Clinical Trials

Abstract

Clinical trial quality assurance audits are performed to ensure that studies were conducted in the manner prescribed by protocol (and described in the final study report); that proper attention was given to subject rights and medical research ethics; and that the data from those trials are accurate and properly documented. The auditing approach that we have found to be most successful consists of evaluating the systems for conducting and controlling clinical trials, and performing detailed audits of specific studies identified as critical to supporting claims of drug safety and efficacy. Study audits involve reviewing all in-house study documentation to identify and select those parameters that are best indicative of subject eligibility, proper adminis­ tration of the protocol medication, proper and timely execution of protocol required tests and measures, and accurate reporting of test results. Data for these parameters are then analyzed to detect questionable trends and patterns. Following this analysis, specific cases and data points are selected for verification against on-site source documents.This technique has proved very successful in identifying problems that could effect the interpretation and acceptability of sponsored clinical trials. We believe that these clinical study audits can, in addition, make a significant contribution to the support of well-conducte d trials, and potentially, to expediting regulatory approval of applications for research or marketing permits.