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Many have inquired about writing an RBM plan due to recent changes in industry execution and an increase in RBM experiences. Moe Alsumidaie responds with a brief methodology on developing a risk management process to create an RBM plan.
With recent changes in industry execution and increasing experiences with using RBM, many peers are inquiring about how to write an RBM plan. Hence, we thought it would be beneficial to provide a brief methodology on developing a risk management process to create an RBM plan. It is important to emphasize that RBM plans vary from one study to another, and the purpose of this article is to offer insights and tips. Tip 1: Complete a Risk Assessment Categorization Tool (RACT) Though, in a previous article, we’ve uncovered evidence that conducting the RACT exercise introduces subjectivity, the tool can be helpful in getting study teams to think about revealing and ranking study risks. Additionally, if study teams follow the suggestions provided in this analysis during the RACT exercise, study teams can improve the quality of risk assessment results, especially by involving other functions within an organization. Though study teams can conduct RACT and implement RBM anytime throughout a study, RACT is most effective when done during the protocol development phase, and can greatly mitigate study risks by enabling study teams to re-design the protocol, and study operations. Tip 2: Identify Critical Study Risks
Study risks can be anything ranging from data collection and transfer all the way through enrollment (you can view the 13 risk categories here). However, it is important to define and categorize your risks in a way that regulatory authorities consider important. Specifically, advice from a former regulatory member suggests that critical risks involve data related to (a) the study’s endpoints, and (b) patient safety. For example, a critical risk could be ECOG score measurements in an oncology trial, changes in carotid stenosis in a cardiovascular trial, or adjudicating expected and unusual adverse events. The key is to identify critical study risks (which the RACT can help with), and it is important to note that critical risks are typically only a few data points. How do you categorize data that is not considered critical? Simply put them in the non-critical risk category. Tip 3: Transform Critical Risks into Analytical Measurements Once you’ve identified critical risks, you have to figure out how to measure them, and this is where key risk and performance indicators come in. According to a document released by the RBM Consortium, a Key Risk Indicator (KRI) is, “an objective measurement of a study-related parameter against a pre-set threshold providing a signal about the risk of a study process or any of its deliverables.” A Key Performance Indicator (KPI) “measures the achievement of an operational or performance target.” To elaborate, if your identified critical risk is ECOG score measurements, your KRI is ECOG score measurement, and your KPI is the analytical measurement of the ECOG score. In your monitoring plan, you have to (a) define risk parameters for deviation, and (b) delineate corrective actions, should there be a deviation. According to the advice from the former regulatory member, you should QC 100% of any modification made to any data point impacting primary safety/efficacy endpoints. However, in my opinion, it is always a good idea to do 100% QC/SDV for data related to the study’s primary safety/efficacy endpoint, and a random QC/SDV of a certain percentage for non-critical data (i.e., 10%-40% of randomly selected data). Tip 4: Write the RBM Plan Writing the RBM plan should be the easiest part, as most of the work has been done when you reach this point. Your task would involve structuring your RBM plan in a coherent way so that any auditor who is not familiar with the study can review the monitoring plan and easily grasp the rationale behind it. The monitoring plan should include (a) an introduction to the identified critical study risks (b) detailed sections on each critical risk, which involves an overview of why the risk is considered critical, the impact of deviations, and the monitoring activity associated with that particular KRI. It is important to define the KPIs (and what happens if there are deviations), and describe the function of centralized and on-site monitors, (c) monitoring activity for non-critical study risks (i.e., random data selection for QCing/SDVing 10%-40% of non-critical study data), and (d) RBM plan adjustments, which basically describes RBM plan change methodology as the study progresses.
Sharon Reinhard, a compliance expert, says “It is important to outline the tasks that will be conducted centrally and on-site, and provide a description of how these activities will be documented. Usually these are important tasks, such as detecting and reviewing protocol deviations, ensuring data entry and query resolution is occurring in a timely manner, or complex cross checking of data between medical history, adverse events and concomitant medications; however, teams often don’t realize they need to document these activities and ensure that documentation reaches the trial master file.” Summary In summary, a comprehensive RBM plan is based on thorough risk-management preparation. Writing a good RBM plan not only enables you to focus resources on critical study areas, but also provides both auditors and regulators with a good impression of risk interpretation and monitoring proficiency. While setting up an RBM plan in the study’s midst can be done, it is strongly advisable to create the monitoring plan during study design, as regulators say time and time again that a well-designed study is the blueprint for good quality.