A Systematic Review to Observe the Impact of Risk-Based Monitoring as Compared to Conventional On-Site Monitoring in Randomised Clinical Trials and Quality Management in Large Cohort Studies
Abstract:International Council for Harmonisation, Good Clinical Practice R2 (ICH GCP R2) focuses on quality management as per risk-based methodology, and there has been a lot of focus on monitoring strategy, which is a mixed method of on-site and centralised monitoring. This systematic review was planned to search for the articles providing the evidence for the impact of risk-based monitoring methodology and monitoring standards for cohort studies. A literature search was performed on MEDLINE, COCHRANE, and WEB OF SCIE… Show more
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