Product IG aECG

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Product Brief- aECG IG

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Product Name - aECG IG

  • HL7 Version 3 Implementation Guide: aECG

aECG Implementation Guide

Type

Informative

Releases

Release 1 - March 21, 2005

Summary

The Annotated ECG (aECG) HL7 standard was created in response to the FDA’s digital ECG initiative introduced November, 2001. The FDA continues to be concerned about evaluating noncardiac drugs for negative cardiac effects, like prolonged QT. Before this initiative, sponsors were already submitting ECG findings tabulations (e.g. QT interval measurements) with their applications. However, the FDA could not systematically evaluate the ECG waveforms and measurement locations those findings came from. Most (if not all) ECGs in current trials were collected with paper and not electronically retained. The next logical step for the FDA was to ask for the digital waveforms and measurement locations (annotations) be made available with the application.The aECG standard was created by HL7’s Regulated Clinical Research Information Management (RCRIM) in response to the FDA’s need.

This implementation guide (IG) offers supplemental material for the January, 2004 aECG standard. It does not by itself provide all the information required to fully implement the standard. This IG should be used in conjunction with the HL7 aECG standard as well as the standard’s XML schema and example aECG file.

Business Case (Intended Use, Customers)

Provide for the systematic evaluation of ECG waveforms and measurment locations on ECG's collected in the clinical evaluation of noncardiac drugs.

Uses of this standard indlude

  • FDA,
  • Pharmaceutical Companies,
  • Device Manufacturers


Benefits

The ability to systematically evaluate digital waveforms allows for the ability to easily compare large amounts of data.

Implementations/ Case Studies (Actual Users)

To facilitate access to the aECG data, FDA has entered into a Cooperative Research and Development Agreement (CRADA) with Mortara Instruments to develop and implement a digital data warehouse to collect, store, and archive aECG data from controlled clinical trials. FDA reviewers have access to this data warehouse to support their assessment of the risk of new drugs. ECG Warehouse

Resources

Work Groups

Relationship to/ Dependencies on, other standards

  • None

Links to current projects in development

  • None