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 SCIENCE were as per the keyword’s searches. All the publications were reviewed for the data that provides evidence risk-based monitoring for randomised clinical trials and its impact to ensure that data integrity, patient safety, and results obtained were reliable. The search resulted in four articles that were qualified that discussed about the comparison between monitoring techniques and the risk-based monitoring methodology in randomised control trials and other interventional trials. Two publications suggested that the SDV% can be <8% and range from 20-50%, respectively, depending on the assessed factors and risks. Although there is research being conducted to generate the evidence for risk-based monitoring and reduced SDV linked to data errors, further empirical quantitative research should happen to show the impact of risk-based methodology for clinical trials. There is a lack of systematic and empirical data for monitoring as part of quality management in cohort studies.

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