TY - GEN
T1 - Regulatory compliance requirements for an open source electronic image trial management system
AU - Rhodes, Colin
AU - Moore, Steve
AU - Clark, Ken
AU - Maffitt, David
AU - Perry, John
AU - Handzel, Toni
AU - Prior, Fred
PY - 2010
Y1 - 2010
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=78650805041&partnerID=8YFLogxK
U2 - 10.1109/IEMBS.2010.5627838
DO - 10.1109/IEMBS.2010.5627838
M3 - Conference contribution
C2 - 21097264
AN - SCOPUS:78650805041
SN - 9781424441235
T3 - 2010 Annual International Conference of the IEEE Engineering in Medicine and Biology Society, EMBC'10
SP - 3475
EP - 3478
BT - 2010 Annual International Conference of the IEEE Engineering in Medicine and Biology Society, EMBC'10
T2 - 2010 32nd Annual International Conference of the IEEE Engineering in Medicine and Biology Society, EMBC'10
Y2 - 31 August 2010 through 4 September 2010
ER -