Contents and Quality Control of Ambulatory Electrocardiographic (Holter) Reports and Data

• Published in: Drug information journal Vol. 34; no. 1; pp. 59 - 68
• Main Authors: Callahan, Timothy S., Charuvastra, Elizabeth
• Format: Journal Article
• Language: English
• Published: Los Angeles, CA SAGE Publications 2000; Pergamon Press; Springer Nature B.V
• Subjects: Biological and medical sciences; Clinical trial. Drug monitoring; Drug development; General pharmacology; Medical sciences; Pharmaceuticals; Pharmacology. Drug treatments; Quality control; Safety; Drug development; Ambulatory electrocardiographic recordings; Holter recordings; Quality control; Holter recording; Human; Drug; Electrodiagnosis; Electrocardiography; Clinical trial; Ambulatory
• ISSN: 2168-4790; 0092-8615; 2168-4804; 2164-9200
• DOI: 10.1177/009286150003400106

Ambulatory electrocardiographic (AECG) recordings, commonly known as Holier recordings, are used in the drug development process to ascertain the safety and efficacy of new pharmaceutical compounds. AECG recordings are very different than the standard 12-lead ECG in the type of information they produce and the technology needed to conduct the analysis. Due to the expertise needed to analyze an AECG recording, sponsors generally contract with a vendor to obtain, analyze, and provide a database from the AECG recordings. Although the contents of the AECG reports vary by vendor, all AECG reports contain similar basic information. As the database provided to the sponsor comes directly from the AECG report, the accuracy of the data and information on the report must be ensured by a strenuous quality control process. To conclude, AECG testing can be a robust method for checking safety and efficacy of pharmaceutical compounds as long as the reports and data are accurate.