Centralized Clinical Trial Imaging Data Management: Practical Guidance from a Comprehensive Cancer Center’s Experience
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Medical imaging is an integral part of clinical trial research and it must be managed properly to provide accurate data to the sponsor in a timely manner (Clune in Cancer Inform 4:33–56, 2007; Wang et al. in Proc SPIE Int Soc Opt Eng 7967, 2011). Standardized workflows for site qualification, protocol preparation, data storage, retrieval, de-identification, submission, and query resolution are paramount to achieve quality clinical trial data management such as reducing the number of imaging protocol deviations and avoiding delays in data transfer. Centralization of data management and implementation of relational databases and electronic workflows can help maintain consistency and accuracy of imaging data. This technical note aims at sharing the practical implementation of our centralized clinical trial imaging data management processes to avoid the fragmentation of tasks among various disease centers and research staff, and enable us to provide quality, accurate, and timely imaging data to clinical trial sponsors.
KeywordsClinical trial and imaging data management Relational database Web form Workflow Imaging de-identification Quality improvement
The authors wish to thank our Radiography and Support Services Supervisor, Anne Commito, and our imaging data associates, Linda Alce, Quinley Miao, and Anika Manigo, for their excellent work in transitioning to the new image transfer workflow and maintaining the current workload. We also thank our imaging technologist teams for their commitment to high-quality scan acquisitions, protocol compliance, and patient care, and our department management and radiologists for their continuous support. We also wish to recognize and thank our CRCs for their invaluable contributions, teamwork, and patient care for patients enrolled in our clinical trials.
Compliance with Ethical Standards
Conflict of Interest
The authors declare that they have no conflict of interest.
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