This white paper explores the clinical utility of limited-lead ECG devices, including single-lead, multi-lead, and six-lead technologies, within clinical trials. It traces the evolution of ECG collection from traditional 12-lead systems to wearable and mobile devices and explains the strengths and limitations of each approach. The document provides guidance on when limited-lead ECGs are appropriate, such as rhythm monitoring and QT interval assessment, and when full 12-lead ECGs are required. Emphasis is placed on patient convenience, decentralized trial designs, and data quality considerations. The paper concludes that limited-lead ECGs can be valuable when deployed with clear objectives, validated methodologies, and centralized oversight.

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