ANSI/HL7 V3 ECG, R 1-2004 健康等级7第3版标准:规定研究.带注释的ECG.发行1

标准号：ANSI/HL7 V3 ECG, R 1-2004
中文标准名称：健康等级7第3版标准:规定研究.带注释的ECG.发行1
英文标准名称：HL7 Version 3 Standard: Regulated Studies - Annotated ECG, Release 1
标准类型：C07
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C07
国际标准分类号：35.240.80
适用范围：Clinical trials on candidate drug products often collect biological data from trial subjects as waveforms or algorithmic representations of those waveforms. After the data have been collected, derived measurements such as QT interval are used to draw conclusions about the safety and effectiveness of the candidate drug. Standards exist for transmitting these derived data and their analysis results from the trial sponsor to the regulatory agencies; but these submissions have not historically included representation of the waveforms, or have at best included an image of the device-generated paper waveform. A new request to include the digital waveform, the algorithmic representations, and the annotations identifying the relevant landmarks (e.g. QRS-wave onset, T-wave offset) that support derived ECG measurements has been proposed by the US FDA. This specification will be used to package such annotated digital waveform data produced by an ECG analysis system for transmission from trial sponsor to a regulatory agency. In no case would a waveform recording device be required to communicate its direct waveform readings using this specification.