Shin Youngbin, Kim Kyung Won, Lee Amy Junghyun, Sung Yu Sub, Ahn Suah, Koo Ja Hwan, Choi Chang Gyu, Ko Yousun, Kim Ho Sung, Park Seong Ho
Department of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
Research Institute of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
JMIR Med Inform. 2019 Aug 30;7(3):e14310. doi: 10.2196/14310.
With the rapid increase in utilization of imaging endpoints in multicenter clinical trials, the amount of data and workflow complexity have also increased. A Clinical Trial Imaging Management System (CTIMS) is required to comprehensively support imaging processes in clinical trials. The US Food and Drug Administration (FDA) issued a guidance protocol in 2018 for appropriate use of medical imaging in accordance with many regulations including the Good Clinical Practice (GCP) guidelines. Existing research on CTIMS, however, has mainly focused on functions and structures of systems rather than regulation and compliance.
We aimed to develop a comprehensive CTIMS to meet the current regulatory guidelines and various required functions. We also aimed to perform computerized system validation focusing on the regulatory compliance of our CTIMS.
Key regulatory requirements of CTIMS were extracted thorough review of many related regulations and guidelines including International Conference on Harmonization-GCP E6, FDA 21 Code of Federal Regulations parts 11 and 820, Good Automated Manufacturing Practice, and Clinical Data Interchange Standards Consortium. The system architecture was designed in accordance with these regulations by a multidisciplinary team including radiologists, engineers, clinical trial specialists, and regulatory medicine professionals. Computerized system validation of the developed CTIMS was performed internally and externally.
Our CTIMS (AiCRO) was developed based on a two-layer design composed of the server system and the client system, which is efficient at meeting the regulatory and functional requirements. The server system manages system security, data archive, backup, and audit trail. The client system provides various functions including deidentification, image transfer, image viewer, image quality control, and electronic record. Computerized system validation was performed internally using a V-model and externally by a global quality assurance company to demonstrate that AiCRO meets all regulatory and functional requirements.
We developed a Good Practice-compliant CTIMS-AiCRO system-to manage large amounts of image data and complexity of imaging management processes in clinical trials. Our CTIMS adopts and adheres to all regulatory and functional requirements and has been thoroughly validated.
随着多中心临床试验中影像终点指标使用的迅速增加，数据量和工作流程的复杂性也随之增加。需要一个临床试验影像管理系统（CTIMS）来全面支持临床试验中的影像流程。美国食品药品监督管理局（FDA）于2018年发布了一份指导方案，用于根据包括《药物临床试验质量管理规范》（GCP）指南在内的多项法规合理使用医学影像。然而，现有的关于CTIMS的研究主要集中在系统的功能和结构上，而非法规和合规性方面。
我们旨在开发一个全面的CTIMS，以满足当前的法规指南和各种所需功能。我们还旨在针对CTIMS的法规合规性进行计算机化系统验证。
通过全面审查许多相关法规和指南，包括国际协调会议-GCP E6、FDA联邦法规汇编第21编第11部分和第820部分、良好自动化生产规范以及临床数据交换标准协会，提取CTIMS的关键法规要求。由包括放射科医生、工程师、临床试验专家和法规医学专业人员在内的多学科团队根据这些法规设计系统架构。对开发的CTIMS进行内部和外部的计算机化系统验证。
我们的CTIMS（爱创医疗）基于由服务器系统和客户端系统组成的两层设计开发，能有效满足法规和功能要求。服务器系统管理系统安全、数据存档、备份和审计追踪。客户端系统提供各种功能，包括去识别化、图像传输、图像查看器、图像质量控制和电子记录。使用V模型在内部进行计算机化系统验证，并由一家全球质量保证公司在外部进行验证，以证明爱创医疗符合所有法规和功能要求。
我们开发了一个符合良好规范的CTIMS——爱创医疗系统，以管理临床试验中大量的图像数据和影像管理流程的复杂性。我们的CTIMS采用并遵守所有法规和功能要求，并已得到充分验证。
