Clinical Quality Assurance: A Method for the Quantification of In-House Audits

Abstract

The purposes of the clinical quality assurance function is to verify that standard operating procedures are being followed correctly and to provide information allowing a judgement on the quality of the clinical studies, independently from the staff directly involved in the clinical studies. The clinical quality assurance department audits the internal study files, the sites of studies, and the reports. The study centers to be audited are chosen at random or because of the questionable quality of a study site. A method for the quantification of in-house audits, using scores, is described. With the proper approach and support, the in-house audits are well accepted by the clinical research personnel, resulting in improved clinical research management systems