Tips on Writing Risk-Based Monitoring Plans

Applied Clinical Trials

With the release of FDA's Guidance on Risk-Based Monitoring (RBM), many clinical operations personnel have been asking how they could implement RBM strategies.

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With the release of FDA's Guidance on Risk-Based Monitoring (RBM), many clinical operations personnel have been asking how they could implement RBM strategies. While there are many tactics that are involved with implementing RBM, one of the strategies includes drafting a Risk-Based Monitoring Plan.  In its guidance, the FDA advises that “each Sponsor design a monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial. Ordinarily, such a risk-based plan would include a mix of centralized and on-site monitoring practices. The monitoring plan should identify the various methods intended to be used and the rationale for their use” [1]. This article will offer general advice around drafting a Risk-Based Monitoring Plan.

Why Do We Need to Revamp Monitoring Plans?

With the increase in clinical IT solutions that offer business insights, the FDA suggests that it is important that clinical operations personnel describe in their monitoring plans how they are to leverage these insights in order to perform RBM.  In addition, each monitoring plan must be tailored for individual studies.  RBM requires clinical operations personnel to interpret and analyze data sets in order to implement strategies that would best benefit their clinical trial as it relates to improving quality, and enhancing clinical trial subject safety.

For example, if a clinical team is to be performing statistical assessments on regulatory documents, the team needs to define the minimum discrepancy rate (i.e. 5%), and to describe the analytical methods used to assess quality. Moreover, clinical teams are to describe the IT system infrastructure, access to datasets, how often data is updated, and verifying data quality (if outsourced, refer to CRO SOPs).

How is a Risk-Based Monitoring Plan Different than Traditional Monitoring Plans?

Traditional monitoring plan topics include the plan’s purpose, training activities, site initiation, interim monitoring visit & close out activities, EDC activities, and AE reporting.   A risk-based monitoring plan incorporates technological, statistical, global and risk-assessment perspectives, as risk-based monitoring plans require a delineation of clinical statistical data analysis techniques through leveraging clinical IT systems, addresses global site monitoring methods, describes study design & endpoints, PI clinical trial experience and previous experience with the Sponsor, EDC analytical audit methodology, stage of study (i.e. start up/maintenance/close out), and clinical data quantity/access.

What Additional Details Should Be Included in Risk-Based Monitoring Plans?

The FDA emphasizes that risk-based monitoring plans should include a detailed description of qualitative & quantitative monitoring methods, how sponsors & CROs are to communicate monitoring results, how sponsors report, address, and improve noncompliant internal business processes, and monitoring finding documentation methodology & follow up.

For instance, if a study team experiences AE reporting defaults, the team is to document business process root causes in a CAPA, fix the issue, and perform appropriate follow up to ensure that no further AEs miss reporting deadlines.

How Do I Get Help in Formulating Risk-Based Monitoring Plans?

A risk based monitoring plan requires clinical operations groups to analyze their IT system capabilities,  evaluate the clinical trial’s protocol, study sites, vendor selections, and a review of clinical operations staff skill sets to determine analytical & statistical abilities.  Clinical trial groups can access expertise that could assist them with developing risk-based monitoring plans.

By Moe Alsumidaie, VP Analytics & Clinical Affairs, DNA Clinical Communications.  Moe Alsumidaie can be reached here. If you are interested in joining the discussion, apply to the Breakthrough Solutions in Clinical Trials & Healthcare Group