FDA Speaks to ECG Data Guidelines
Cordium Links is a partner in the Mortara ECG Warehouse, utilizing any required, state-of-the-art ECG digital equipment. The excerpt below from the FDA’s website on Electronic and Regulatory Submissions and Review document explains its ECG guidelines.
Providing
Digital Electrocardiogram (ECG) Data
Why:
FDA is interested in having access to ECG waveform
data collected during the course of "definitive" studies
about drug effects on ventricular repolarization and annotated for
interval measurements. The basis for this interest is described in
detail in the concept paper, "The
Clinical Evaluation of QT Interval Prolongation and Proarrhythmic Potential
for Non-antiarrhythmic Drugs," jointly authored by the U.S.
and Canadian regulatory authorities and discussed at a joint FDA/DIA
meeting in January 2003.
How:
In 2004, FDA announced its intent to accept
annotated ECG waveform data in electronic format (XML), following the
Health Level Seven (HL7)
Annotated ECG Waveform Data Standard (aECG), accredited by the American
National Standards Institute. You can find more detailed information
on the aECG message standard and supporting materials by visiting the
HL7 Version 3 ECG page and following the "Link to ECG Annotation
Message Review Material." 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.
You can upload data for FDA access at the Mortara ECG
Warehouse.