A Contract Research Organization's Challenge: Validating Cutting-Edge Software for Imaging in Clinical Studies

Abstract

Conducting imaging in clinical trials often involves the use of cutting-edge computer software. The computer systems featured in the medical imaging workstations used in clinical investigations must be validated prior to data collection in support of a regulatory submission. Good clinical practice (GCP) guidelines, derived from international standards adopted by the US FDA, are the benchmarks for drug and device clinical trials that may involve imaging data. Computer systems used in all FDA-regulated clinical research must be validated according to GCP standards.

The ACR Image Metrix approach to the challenge of computer system validation in two different clinical trials is described in case study format. By following strict work processes, we achieved installation qualification and performance qualification. Although we did not fully understand the complex mathematics and physics underlying the software and imaging workstations, we executed system validation by consistently focusing on standard operating procedures with the computerized system.

Keywords

Computer system validation Imaging clinical trials Software validation GCP guidelines Imaging workstation validation

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