FDA guidance: Risk-based approaches to monitoring clinical investigations

August 30, 2011 by MassDevice

By Stewart Eisenhart, Emergo Group

New guidance from the US Food and Drug Administration recommends adoption of more risk-based methods by sponsors to monitor clinical investigations including investigational device exemptions (IDEs) and Investigational New Drugs (INDs).

Existing regulations require sponsors to monitor the conduct and progress of their clinical investigations, but do not prescribe specific steps to follow in order to comply. Although various methods of effective monitoring practices are available, sponsors have primarily relied on on-site evaluations of study sites to review clinical data. The FDA’s new guidance emphasizes the use of risk-based methods such as focusing on the most critical data elements of a clinical investigation would better ensure protection of human subjects as well as study quality. Centralized off-site monitoring of multiple clinical study sites would also make sponsors’ efforts to ensure quality and integrity of clinical data more efficient.

The guidance recommends two types of clinical investigation monitoring, including on-site monitoring at study sites to identify data entry errors, verify existence of study documentation and assess staff compliance with study protocols. This method should be used to assess critical study data and identify major risks. Second, centralized monitoring of clinical investigations by off-site personnel can assess data quality and verify source data in real time, as well as perform aggregate statistical analyses and keep track of performance metrics. Sponsor ability to utilize centralized monitoring will depend on accessibility to electronic record and data capture systems.

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