Auditing New Electronic Systems

Abstract

Sponsors and contract research organizations (CROs) are developing more efficient computerized methods and electronic systems to record and process case report form (CRF) data. New electronic systems vary in complexity and may be represented by a personal computer at an investigator's site, a CRO site data management technology system, or a sponsor's fully integrated clinical data management system. Regardless of the type of electronic system used in Good Clinical Practice (GCP) applications, data quality and data integrity are the key areas to assess when auditing new electronic systems. Attributes of a successful electronic system audit include consideration of important planning elements, evaluation and assessment techniques for giving appropriate credit, and specific key areas to focus on during the audit related to computer system integrity, validation, and management support issues. This article provides audit strategies to assist the quality assurance audit team with planning for an effective audit, and accurately assessing data quality, data integrity, and good computer validation practices for new electronic systems.