Risk Identification for Centralized Monitoring

Identifying the key risks for your clinical study to be monitored during centralized monitoring is crucial for successful implementation of risk-based monitoring initiatives. At the same time, identifying and defining right Key Risk Indicators (KRIs) for the risk areas recognized is also of utmost importance in order to measure and monitor risks correctly during the conduct phase. KRIs are an important tool within risk management to facilitate risk monitoring, reporting and mitigation process.   KRIs for site performance  

Identifying the right KRIs will correspond to the risks that will be monitored centrally throughout the trial. The KRIs should be measurable (quantifiable), comparable to assess the trends over the period of time and predictable to provide early warning signals. Also, KRIs should be meaningful and informative in order to assess the status of risk and effect of the control used or action deployed. For example, if “subject recruitment” is one of the risk areas identified for a study then to track and control this risk effectively, the KRI could be “subject recruitment rate per month per site.” A specified KRI will allow monitoring of each site performance as far as patient recruitment is concerned and--at the same time--will allow monitoring of actual overall patient recruitment rate for a study versus the planned patient recruitment rate.   Once the right KRI is identified, the next step is to define the tolerance limit or threshold value to trigger the action when that specific value of any KRI reaches. The threshold for KRIs should be defined in such way that it will allow timely/proactive action planning if a particular risk triggers reaches during the conduct. For example, a KRI “protocol deviation per subject” when the threshold value is reached, the study or project manager can look into deploying the action which is planned in the beginning during risk assessment to prevent this risk from developing into an issue. The planned action could be close monitoring of the sites or additional training to the site staff to avoid these protocol deviations in future. Based on the criticality of KRIs for a study, different threshold levels can be planned which allow for different escalation levels and further close monitoring of KRIs to deploy proactive actions whenever needed. If completing subject recruitment on time is vital for a study, it would be advisable to have different levels of threshold, for example first level could be “ >5% to 15% of sites below expected recruitment rate” (yellow indicator) and then second level would be “ >15% sites below expected recruitment rate” (red indicator).   Some Examples of KRIs for Investigational Site Performances:

While using risk based monitoring approach for a clinical study, it is crucial to decide the right number of KRIs that will allow effective centralized monitoring of the study. There should not be too many KRIs as excessive information can be confusing. However, the number of KRIs should not be inadequate for the ability to visualize all key risks involved in the study. Depending on the complexity and spread of the study, the KRI number should be optimally planned to implement risk based monitoring in its truest sense.   Ashok Ghone, Ph.D. is Vice-President, Global Services at MakroCare USA. He can be reached at ashok.ghone@makrocare.com