New trends in site monitoring

Improving the efficacy and effectiveness of clinical monitoring is key in managing study budgets. A report published by Medidata Solutions on 1 January, 2012 suggests a marked change in the approach to site monitoring. It appears that clinical research and development organisations are moving away from the traditional approach to site monitoring. Thus, the standard practice of using 100% source document verification (SDV) of subject eCRF data may be replaced by targeted sampling where data are verified against source charts.

The report by Medidata Solutions indicates a downward trend for the average percent of eCRF data marked for SDV from approximately 85% in 2007 to around 67% in 2010. The information is based on data from over 1,500 studies conducted by 50 CROs. It suggests a steady and significant downward trend over the 4-year period of analysis. It appears reasonable to expect this trend to continue. The apparent support for this approach from the FDA in its recent guidance for risk-based site monitoring practices can only be expected to further encourage adoption. However, although risk-based strategies have been proposed to result in increased visit productivity by as much as 40%, reducing operational costs and allowing monitors to focus on value-added activity, thus far they do not appear to be appropriate for smaller early phase clinical studies.

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