Regulatory compliance requirements for an open source electronic image trial management system
- 1 August 2010
- conference paper
- Published by Institute of Electrical and Electronics Engineers (IEEE) in 2018 40th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC)
- Vol. 2010 (1094687X), 3475-3478
- https://doi.org/10.1109/iembs.2010.5627838
Abstract
There is a global need for software to manage imaging based clinical trials to speed basic research and drug development. Such a system must comply with regulatory requirements. The U.S. Food and Drug Administration (FDA) has regulations regarding software development process controls and data provenance tracking. A key unanswered problem is the identification of which data changes are significant given a workflow model for image trial management. We report on the results of our study of provenance tracking requirements and define an architecture and software development process that meets U.S. regulatory requirements using open source software components.Keywords
This publication has 9 references indexed in Scilit:
- Integrating Clinical Trial Imaging Data Resources Using Service-Oriented Architecture and Grid ComputingNeuroinformatics, 2010
- A wake-up call for the engineering and biomedical science communitiesIEEE Circuits and Systems Magazine, 2009
- Use of Imaging Biomarkers for Regulatory StudiesJournal of Bone and Joint Surgery, 2009
- Provenance in neuroimagingNeuroImage, 2008
- Silent Cerebral Infarct Transfusion (SIT) Trial Imaging Core: Application of Novel Imaging Information Technology for Rapid and Central Review of MRI of the BrainJournal of Digital Imaging, 2008
- Development of a Queriable Database for Oncology Outcome AnalysisPublished by Springer Science and Business Media LLC ,2008
- Globus MEDICUS - federation of DICOM medical imaging devices into healthcare Grids.2007
- IT solutions for imaging biomarkers in biopharmaceutical research and developmentIBM Systems Journal, 2007
- The price of innovation: new estimates of drug development costsJournal of Health Economics, 2003