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

Annu Int Conf IEEE Eng Med Biol Soc. 2010:2010:3475-8. doi: 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.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Clinical Trials as Topic / legislation & jurisprudence*
  • Clinical Trials as Topic / standards
  • Computer Security / legislation & jurisprudence*
  • Computer Security / standards
  • Diagnostic Imaging / standards*
  • Government Regulation*
  • Guideline Adherence / legislation & jurisprudence*
  • Quality Assurance, Health Care / legislation & jurisprudence*
  • Quality Assurance, Health Care / standards
  • United States