Regulatory compliance requirements for an open source electronic image trial management system.
Conference proceedings : ... Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual Conference（2010）
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.
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Key words
public domain software,medical information systems,image trial management,open source electronic image,using open source software components,workflow model,provenance tracking,regulatory compliance requirements,dicom,clinical trial,process control,management system,drug development,clinical trials,software development process
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