Methods
Clinical Trials
Risk-adapted monitoring is not inferior to extensive on-site monitoring: Results of the ADAMON cluster-randomised study
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.
DOI: 10.1177/1740774517724165