New FDA Guidance Calls for Increased Emphasis on Centralized Trial Monitoring

A new guidance document released by the US Food and Drug Administration on 6 August 2013 calls on sponsors to develop centralized risk-based monitoring strategies for clinical trials involving medical products with the ultimate goal of enhancing protections for human subjects while simultaneously improving the quality of clinical trial data

In the guidance, Oversight of Clinical Investigations, A Risk-Based Approach to Monitoring, FDA “encourages greater use” of centralized monitoring practices compared to historical trends that emphasized on-site monitoring as it applies to pharmaceutical, biologics, medical devices and combination products.

“Centralized monitoring is a remote evaluation carried out by sponsor personnel or representatives (e.g., clinical monitors, data management personnel, or statisticians) at a location other than the sites at which the clinical investigation is being conducted. Centralized monitoring processes can provide many of the capabilities of on-site monitoring as well as additional capabilities.”

FDA’s guidance lists several it says would “reflect a modern, risk-based approach that focuses on critical study parameters and relies on a combination of monitoring activities to oversee a study effectively,” such as the use of centralized monitoring.

• Supplement or reduce the frequency and extent of on-site monitoring
• Target on-site monitoring by identifying higher risk clinical sites
• Communication with Study Site Staff
• Review of Site’s Processes, Procedures, and Records
• Source Data Verification and Corroboration

DOCUMENTING MONITORING ACTIVITIES
Documentation of monitoring activities generally includes the following:

• The date of the activity and the individual(s) conducting and participating in it
• A summary of the data or activities reviewed
• A description of any noncompliance, potential noncompliance, data irregularities, or other deficiencies identified
• A description of any actions taken, to be taken, or recommended, including the person responsible for completing actions and the anticipated date of completion

Documentation of monitoring should include sufficient detail to allow verification that the monitoring plan was followed.

Marathon Product, Inc. provides wireless and networked products for centralized monitoring compliance.