JMIR Publications

ABSTRACT

Background:

In recent clinical trials, using medical imaging has been rapidly increased due to the image endpoints, and the current trials have conducted as multicenter trial over the world. The larger the study, and the more complex the imaging endpoints, the more sponsors risk an overwhelming imaging data and complex work flow, requiring a dedicated information technology (IT) system to manage imaging data. Indeed, to develop standardized IT system for medical imaging with regulations is another critical point in order to conduct as a high quality and reliable clinical trial.

Objective:

Asan Image Matrics (AIM), as an academic imaging core lab in Asan Medical Center (AMC) in Korea, aim to introduce our clinical trial imaging management system (CTIMS), is called AiCRO sys tem, and discuss a variety of its perspectives including development, modules, regulations, and validation process in this study.

Methods:

This study describes three different processes to design and utilize the AiCRO system as an all-in-one system for medical imaging, which are functional and regulatory requirements, development of AiCRO system, and computer system validation. All processes primarily complied to FDA 21 CFR Part 11 for imaging in the clinical trial and Good Automated Manufacturing Practice (GAMP®) 5 Guide for Compliant GxP Computerized Systems, as well as other regulatory agencies and international societies for the computer system.

Results:

Our AiCRO system was developed based on a two-layer design, the AiCRO server system and the AiCRO client system, using application programming interface (API) for communication between two systems. It had also a diversity of effective modules to manage and analyze images, including de-identification, image transfer and storage, data security, image quality control, electronic CRF record and audit trail. These modules were created by user requirements of clinical trial, following both international and domestic compliances of the clinical trials. Furthermore, the AiCRO system was validated by internal V-model with software validation process (Installation Qualification, Operation Qualification, and Performance Qualification) regularly and by external global quality assurance company. The AiCRO system has been successfully implemented into more than 20 pharmaceutical multi-center clinical trials since 2017 in both domestic and international sites/hospitals.

Conclusions:

The CTIMS, AiCRO system, was developed for clinical trial imaging, following required clinical trial guidelines and computer system regulations to manage medical image data from multi sites. The strength of using the AiCRO system could be argued that every required computer system validation and regulations including data format in the clinical trial imaging is standardized to provides more effective performance and more reliable outcomes in the all-in-one system.