Section 1e: Version 3 (V3)
Section 2: Clinical and Administrative Domains
Section 3: Implementation Guides

HL7 Version 3 Implementation Guide: Annotated ECG (aECG) R1, Release 2 - US Realm

DESCRIPTION

This HL7 Version 3 implementation guide offers supplemental material for the January, 2004 annotated ECG (aECG), standard. This implementation guide is not complete in itself and should be used in conjunction with the HL7 aECG standard, R1 as well as the standard’s XML schema and example aECG file.

ALTERNATIVE NAMES

HL7 Version 3 Implementation Guide: Annotated ECG (aECG) R1, Release 2 - US Realm may also go by the following names or acronyms:

"HL7 V3 IG: Regulated Studies; Annotated ECG R1, R2", "HL7 aECG Implementation Guide, R1", V3, aECG, "annotated ECG Implementation Guide"

TARGETS

  • Healthcare Provider Institutions
  • FDA and Other Regulatory Agencies
  • Pharmaceutical Companies 
  • Device Manufacturers

BENEFITS

  • Systematically evaluates digital waveforms to easily compare large amounts of data
  • Provides for the systematic evaluation of ECG waveforms and measurement locations on ECG's collected in the clinical evaluation of noncardiac drugs

IMPLEMENTATIONS/CASE STUDIES

  • Mortara Instruments and A.M.P.S. llc

DEVELOPMENT BACKGROUND

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.

 

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.

RELATED DOCUMENTS

HL7 Version 3 Implementation Guide: Annotated ECG (aECG) R1, Release 2 - US Realm

(Download) (1.54 MB)

TOPIC

  • Regulated Studies

BALLOT TYPE

  • Informative

STATUS DATE

2015-06-25

RESPONSIBLE WORK GROUP

Biomedical Research and Regulation

FAMILY

  • V3

CURRENT STATE

  • Stable

REALM

  • US Realm