| Literature DB >> 21097264 |
Colin Rhodes1, Steve Moore, Ken Clark, David Maffitt, John Perry, Toni Handzel, Fred Prior.
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.Entities:
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Year: 2010 PMID： 21097264 PMCID： PMC4559082 DOI： 10.1109/IEMBS.2010.5627838
Source DB: PubMed Journal: Annu Int Conf IEEE Eng Med Biol Soc ISSN： 2375-7477