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FDA Publishes Final Guidance on Risk-Based Monitoring August 18, 2013

Posted by Michael Hamrell in Regulatory Thoughts.
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The FDA recently published the final Guidance for Industry: Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring in August 2013. This is the final version of the draft released in August 2011.

This guidance document reiterates the FDA current thinking on a risk-based approach to monitoring. There is a growing consensus that risk-based approaches to monitoring, focused on risks to the most critical data elements and processes necessary to achieve study objectives, are more likely than routine visits to all clinical sites and 100% data verification to ensure subject protection and overall study quality. This final guidance goes into some detail on different methods that can be used to put in place an effective monitoring plan for a clinical study. This guidance makes clear that sponsors can use a variety of approaches to fulfill their responsibilities for monitoring investigator conduct and performance in investigational new drug (IND) studies conducted under 21 CFR §312 or investigational device exemption (IDE) studies conducted under 21 CFR §812. The guidance describes strategies for monitoring activities that 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.

FDA recognizes that this guidance places greater emphasis on centralized monitoring than appeared feasible at the time ICH E6 was finalized. However, FDA considers the approach to monitoring described in this guidance to be consistent with ICH E6 and ISO 14155:2011 (devices).

Again the guidance does not suggest eliminating on-site visits. Rather, what it operationalizes and supports is the role of centralized review of data along with on-site visits to enhance quality. The guidance specifically encourages greater use of centralized monitoring methods where appropriate. CRAs will still make on-site visits, but they will spend less time focusing on some issues, like data consistency that can easily be checked by a computer, and focus on items that need a close live eye view to verify, like ICF forms, visit dates, or AEs not reported, etc. The guidance suggests that sponsors should prospectively identify critical data and processes that if inaccurate, not performed, or performed incorrectly would threaten the protection of human subjects or the integrity of the study results.

This guidance reflects FDA’s general approach in recent years to risk based approach to quality in a number of areas. This includes manufacturing quality, safety reporting and even FDA’s own inspection planning in CDER is moving to a risk based approach. The guidance discusses risk assessment as applied in the context of clinical monitoring. Risk assessment generally involves identifying risks, analyzing risks, and then determining whether risks need to be modified by implementing controls. The key tool in risk assessment and planning is to develop and implement a formal monitoring plan for each study that addresses the risk plan in writing.

The guidance also emphasizes that one of the key risk tools in obtaining quality data is a well designed and articulated protocol and related tools such as the informed consent document and case report forms.

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