title: The Cardiac Safety Research Consortium electrocardiogram warehouse: thorough QT database specifications and principles of use for algorithm development and testing.
abstract: This document examines the formation, structure, and principles guiding the use of electrocardiogram (ECG) data sets obtained during thorough QT studies that have been derived from the ECG Warehouse of the Cardiac Safety Research Consortium (CSRC). These principles are designed to preserve the fairness and public interest of access to these data, commensurate with the mission of the CSRC. The data sets comprise anonymized XML formatted digitized ECGs and descriptive variables from placebo and positive control arms of individual studies previously submitted on a proprietary basis to the US Food and Drug Administration by pharmaceutical sponsors. Sponsors permit the release of these studies into the public domain through the CSRC on behalf of the Food and Drug Administration's Critical Path Initiative and public health interest. For algorithm research protocols submitted to and approved by CSRC, unblinded "training" ECG data sets are provided for algorithm development and for initial evaluation, whereas separate blinded "testing" data sets are used for formal algorithm evaluation in cooperation with the CSRC according to methods detailed in this document.
authors.affiliation: Division of Cardiology, Department of Medicine, Weill Cornell Medical College, New York, NY 10065, USA. pkligfi@med.cornell.edu
authors.forename: Paul
authors.initials: P
authors.lastname: Kligfield
authors.forename: Cynthia L
authors.initials: CL
authors.lastname: Green
authors.forename: Justin
authors.initials: J
authors.lastname: Mortara
authors.forename: Philip
authors.initials: P
authors.lastname: Sager
authors.forename: Norman
authors.initials: N
authors.lastname: Stockbridge
authors.forename: Michael
authors.initials: M
authors.lastname: Li
authors.forename: Joanne
authors.initials: J
authors.lastname: Zhang
authors.forename: Samuel
authors.initials: S
authors.lastname: George
authors.forename: Ignacio
authors.initials: I
authors.lastname: Rodriguez
authors.forename: Daniel
authors.initials: D
authors.lastname: Bloomfield
authors.forename: Mitchell W
authors.initials: MW
authors.lastname: Krucoff
mesh_terms: D000465:Algorithms; D035843:Biomedical Research; D004562:Electrocardiography / Q000379:methods*; D006801:Humans; D008133:Long QT Syndrome / Q000503:physiopathology*; D012815:Signal Processing, Computer-Assisted; D014481:United States