Risk approach comes to site monitoring

An emerging risk-based approach to site monitoring uses partial source document verification in place of traditional full source document verification (SDV) coverage. In the risk-based approach, monitoring targets the most critical review activities at sites requiring the highest level of attention.

The approach promises a clinical trial database of equal or higher quality than that of full SDV, argues Ashwin Mundra of Medidata Solutions. The effort required in providing full coverage could divert attention away from such monitoring activities as focusing on SDV review of the most critical efficacy and safety data and assessing site protocol compliance.

Among the considerations for researchers interested in using a risk-based approach is focusing more SDV coverage on the most critical data: primary endpoint data and key safety data, including adverse events. Another consideration is to require higher SDV coverage on the first subjects enrolled at each site to establish a data quality standard.

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