Regulatory compliance requirements for an open source electronic image trial management system

Colin Rhodes, Steve Moore, Ken Clark, David Maffitt, John Perry, Toni Handzel, Fred Prior

Research output: Chapter in Book/Report/Conference proceedingConference contributionpeer-review

3 Scopus citations

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.

Original languageEnglish
Title of host publication2010 Annual International Conference of the IEEE Engineering in Medicine and Biology Society, EMBC'10
Pages3475-3478
Number of pages4
DOIs
StatePublished - 2010
Event2010 32nd Annual International Conference of the IEEE Engineering in Medicine and Biology Society, EMBC'10 - Buenos Aires, Argentina
Duration: Aug 31 2010Sep 4 2010

Publication series

Name2010 Annual International Conference of the IEEE Engineering in Medicine and Biology Society, EMBC'10

Conference

Conference2010 32nd Annual International Conference of the IEEE Engineering in Medicine and Biology Society, EMBC'10
Country/TerritoryArgentina
CityBuenos Aires
Period08/31/1009/4/10

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