CLINICAL OPERATIONS & OUTSOURCING


Stakeholders in clinical research should thoroughly read and understand the entirety of document. The RBM document includes many informative statements by the Agency. While I will outline 10 key points that I feel are most relevant to risk assessment, please note that my list and opinions do not constitute a comprehensive summary of the document’s contents or a legal interpretation of the FDA’s statements. As described in Point 7 in the table on the


previous page, the Agency highlights that the traditional on-site monitoring model with 100% Source Data Verification (SDV), which is often perceived as the FDA’s preference is just a ‘perception’. The Agency has not explicitly defined a preferred method. It seems that the Agency acknowledges a risk-based approach, focusing efforts on “critical data elements and processes” as outlined in Point 8, may be more effective than the traditional 100% SDV model. Effective study oversight, investigational site


training, and monitoring all begin with a comprehensive risk assessment to identify which critical data and processes require enhanced monitoring and oversight. The risk assessment involves three variables: • Probability: the likelihood of errors occurring


Figure 1: Impact, Probability, and Detectability


• Impact: the consequences of such errors on human subject protection and trial integrity


• Detectability: the extent to which such errors would be detected Impact and probability are additive, where


an event with high probability and high impact is a high-risk event. Detectability adds a third dimension, influencing the overall risk inversely; a high-risk event with high detectability may present a lower overall risk. While the additive effect of Impact and Probability is illustrated in Figure 1, the third dimension of detectability is harder and more challenging to represent.


The first step for sponsors to effectively oversee clinical investigations starts with identifying the associated risks


Outsourcing in Clinical Trials Handbook | 27


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