Trust Expert Teams and Think Quality Control in Risk-Based Monitoring

June 28, 2013

Sponsors should assemble a multidisciplinary team to focus on data quality and utilize individual member skills to monitor sites using a risk-based approach, an expert site monitor says.

While risk-based monitoring has long been used by the NIH, the concept is still relatively new to the commercial clinical research arena. A 2011 FDA draft guidance stated that, contrary to popular belief, on-site monitoring and 100 percent data verification of trials are not always needed nor preferable.

Instead, the agency recommended that sponsors use centralized monitoring and design plans with human subject protection and data integrity risks in mind. As clinical trials have become larger and more complex, sponsors and CROs can be more efficient in how they spend their resources by adopting a risk-based monitoring approach, the agency reasoned.

The FDA cautioned, however, that such monitoring plans should justify the methods used and include processes to communicate monitoring results, manage cases of noncompliance and train study monitors.

The FDA has so far not finalized its position on risk-based monitoring, which has left sponsors and CROs confused as to what monitoring plans pass agency muster, said Lynn King, assistant vice president of operations at Rho, a Chapel Hill, N.C.-based CRO. “We are at that point where we don’t have a lot of history, we don’t have documented evidence that risk-based monitoring approaches are approvable,” she said. “So we’re in a tough spot.”

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