Standards for ECGS in Clinical Trials

Abstract

Practices surrounding electrocardiogram (ECG) data need careful scrutiny, as there is significant variability in equipment, acquisition techniques, systems for transfer of waveforms to the interpreter, interpretive styles, and report format. This article addresses the prerequisites for the accurate and reliable acquisitions of ECGs and their use as part of a new drug application. Ten proposed standards are presented. Eventually, a standardized data specification for ECG information will be constructed to achieve the global harmonization sought for the next century's worldwide data exchange needs.