ArticleJMIR medical informatics2019
A Good Practice-Compliant Clinical Trial Imaging Management System for Multicenter Clinical Trials: Development and Validation Study.
Article in JMIR medical informatics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
7 citing papers in PubMed.
- Effect of empagliflozin with or without carvedilol on tricuspid regurgitation and right ventricular remodeling: PROVE trial.Journal of cardiovascular imaging · 2026Article
- How best to combine DWI and T2WI to predict pathologic complete response: a multi-center study on interpreting MRI following chemoradiotherapy of rectal cancer.European radiology · 2026Article
- The Development of an Artificial Intelligence Video Analysis-Based Web Application to Diagnose Oropharyngeal Dysphagia: A Pilot Study.Brain sciences · 2024Article
- Interpretation of Complete Tumor Response on MRI Following Chemoradiotherapy of Rectal Cancer: Inter-Reader Agreement and Associated Factors in Multi-Center Clinical Practice.Korean journal of radiology · 2024Article
- Development and validation of an ensemble artificial intelligence model for comprehensive imaging quality check to classify body parts and contrast enhancement.BMC medical imaging · 2022Article
- Article
- Abbreviated MRI with optional multiphasic CT as an alternative to full-sequence MRI: LI-RADS validation in a HCC-screening cohort.European radiology · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWith 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.
objectiveWe 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.
methodsKey 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.
resultsOur 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.
conclusionsWe 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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.