The Cardiac Safety Research Consortium electrocardiogram warehouse: thorough QT database specifications and principles of use for algorithm development and testing.

Journal Article (Review)

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.

Full Text

Duke Authors

Cited Authors

  • Kligfield, P; Green, CL; Mortara, J; Sager, P; Stockbridge, N; Li, M; Zhang, J; George, S; Rodriguez, I; Bloomfield, D; Krucoff, MW

Published Date

  • December 2010

Published In

Volume / Issue

  • 160 / 6

Start / End Page

  • 1023 - 1028

PubMed ID

  • 21146653

Electronic International Standard Serial Number (EISSN)

  • 1097-6744

Digital Object Identifier (DOI)

  • 10.1016/j.ahj.2010.09.002

Language

  • eng

Conference Location

  • United States