In August, the FDA issued final guidance on using a risk-based approach in clinical investigations. These should not only raise the standards of monitoring but save money too! The new guidelines have now been added to Whitehall Training’s US GCP course.
The FDA’s Guidance for Industry - Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring describes risk-based monitoring strategies to oversee a clinical trial effectively. They also cover applying risk management strategies in preparing detailed monitoring plans and the need for more flexible approaches to monitoring. Sponsors are encouraged to increase their use of technology and employ centralised monitoring to give them better oversight of clinical trials.
Centralized Monitoring…
FDA defines centralized monitoring as: “a remote evaluation … 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.”
The FDA recommends that centralized monitoring techniques should used be where possible to supplement or reduce the frequency and extent of any on-site monitoring activities that can be carried out as well (or better) remotely or using purely centralized processes.
When using centralised monitoring, sponsors should ensure that the processes and expectations for site record-keeping, data entry and reporting are well defined and ensure timely access to trial data and supporting documentation. This should ideally be the case for on-site monitoring as well but the guidelines place a greater emphasis when using centralized monitoring.
The Monitoring Plan…
FDA recommends that each trial has a monitoring plan tailored to its individual subject protection and data integrity risks. The plan should identify the various methods to be used and the rationale for each trial.
If sponsors intend to rely heavily on centralized monitoring practices, the monitoring plan should identify when one or more on-site monitoring visits would be appropriate. The plan should include the types of monitoring visit (e.g., on-site or centralized), as well as the frequency and the extent of monitoring.
All sponsor and CRO personnel involved with monitoring, including those who review or determine appropriate action regarding potential issues identified through monitoring, should review the monitoring plan.
The key message from this guideline is that sponsors may use a variety of approaches to fulfil their monitoring responsibilities including risk-based approaches to ensure appropriate oversight of monitoring activities in clinical trials and that they should have an appropriate monitoring plan in place.
