Risk-adapted monitoring is not inferior to extensive on-site monitoring: Results of the ADAMON cluster-randomised study
Academic source · Clinical Trials
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Site published: 2026-11-07 · Updated: 2026-11-07
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What the paper reports
Historical methods study (2017): 213 sites from 11 academic trials were randomised; audits covered 156 sites and 1,618 patients. Risk-adapted monitoring met the specified non-inferiority criterion for major audit findings while using fewer resources. High-risk trials were excluded. The findings inform monitoring design, not the performance of any Chinese CRO.
Why this paper is included
Methods relevance: assess risk-based oversight within the whole quality system; reduced visits cannot compensate for a weak protocol.
The interpretation above is analysis, not a conclusion attributed to the original source.
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