Notable standards

HL7 aECG Implementation Guide

The Annotated ECG (aECG) HL7 standard was created in response to the FDA’s digital ECG initiative introduced November, 2001. A necessary step for submitting the ECG waveforms and annotations to the FDA was to have a standard format for the data. An evaluation of current ECG waveform standards found no existing standards that met all the FDA’s needs. Therefore the FDA, sponsors, core laboratories, and device manufactures worked together within HL7 to create a standard to meet the needs. The aECG standard was created by HL7’s Regulated Clinical Research Information Management (RCRIM) in response to the FDA’s need. It passed final balloting in January, 2004, and was accepted by ANSI May, 2004. 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. Realized by Fabio Badilini, A.M.P.S. LLC and Barry D. Brown, Mortara Instruments, Inc.

Beyond the Schema

Tips for Conforming to the HL7 aECG Standard for the digital submission of ECGs. A ten pages documents that helps with the practical implementation of the HL7 aECG Standard Implementation. Realized by Fabio Badilini, A.M.P.S. LLC and Barry D. Brown, Mortara Instruments, Inc.

The ISHNE Holter Standard Output File Format

ISHNE Standard Output Format for Digital Holter Data is a single file structurally organized in a header followed by a (larger) data block containing all stored electrocardiographic (ECG) digital samples. The format of this file is the outcome of several meetings with different manufacturers and it aims to maximize the ratio between simplicity and flexibility.

Guidance for Industry S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals

This guidance describes a nonclinical testing strategy for assessing the potential of a test substance to delay ventricular repolarization. The guidance includes information concerning nonclinical assays and integrated risk assessments. The assessment of the effects of pharmaceuticals on ventricular repolarization and proarrhythmic risk is the subject of active investigation. When additional data (nonclinical and clinical) are accumulated in the future, they will be evaluated and this guidance might be revised. Realized by the CDER and CBER centers of the FDA.

Guidance for Industry ICH E14 THE CLINICAL EVALUATION OF QT/QTc INTERVAL PROLONGATION AND PROARRHYTHMIC POTENTIAL FOR NON-ANTIARRHYTHMIC DRUGS

This guidance provides recommendations to sponsors concerning the design, conduct, analysis, and interpretation of clinical studies to assess the potential of a drug to delay cardiac repolarization. This assessment should include testing the effects of new agents on the QT/QTc interval as well as the collection of cardiovascular adverse events. The investigational approach used for a particular drug should be individualized, depending on the pharmacodynamic, pharmacokinetic, and safety characteristics of the product, as well as on its proposed clinical use. The assessment of the effects of drugs on cardiac repolarization is the subject of active investigation. When additional data (nonclinical and clinical) are accumulated in the future, this document may be reevaluated and revised. Realized by the CDER and CBER centers of the FDA.