標準號：ANSI/HL7 V3 ECG, R 1-2004
中文標準名稱：健康等級7第3版標準:規(guī)定研究.帶注釋的ECG.發(fā)行1
英文標準名稱：HL7 Version 3 Standard: Regulated Studies - Annotated ECG, Release 1
標準類型：C07
發(fā)布日期：1999/12/31 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C07
國際標準分類號：35.240.80
適用范圍：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.