title: Regulatory compliance requirements for an open source electronic image trial management system.
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.
authors.affiliation: VirtualScopics Inc., Rochester, NY 14625, USA. Colin_Rhodes@virtualscopics.com
authors.forename: Colin
authors.initials: C
authors.lastname: Rhodes
authors.forename: Steve
authors.initials: S
authors.lastname: Moore
authors.forename: Ken
authors.initials: K
authors.lastname: Clark
authors.forename: David
authors.initials: D
authors.lastname: Maffitt
authors.forename: John
authors.initials: J
authors.lastname: Perry
authors.forename: Toni
authors.initials: T
authors.lastname: Handzel
authors.forename: Fred
authors.initials: F
authors.lastname: Prior
mesh_terms: D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000592:standards; D016494:Computer Security / Q000331:legislation & jurisprudence* / Q000592:standards; D003952:Diagnostic Imaging / Q000592:standards*; D033161:Government Regulation; D019983:Guideline Adherence / Q000331:legislation & jurisprudence*; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence* / Q000592:standards; D014481:United States