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Remote Source Data Review (SDR) has become a vital component of centralized monitoring in modern clinical trials. It supports real-time oversight, risk-based quality management, and subject safety assurance. However, its growing use has led to heightened regulatory scrutiny from agencies like the FDA, EMA, and MHRA.
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Source Data Review (SDR) is a cornerstone of centralized monitoring in decentralized clinical trials. While technology enables remote access to subject-level data, the success of SDR depends on structured oversight and measurable performance. Regulatory agencies such as the FDA and EMA expect sponsors to not only perform SDR but also monitor its quality using meaningful metrics. These indicators ensure that reviewers are effective, findings are acted upon, and the entire process remains compliant with GCP principles.
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