Risk-Based Monitoring: Answers from a Recent Webcast

SPOTLIGHT EVENTRisk-Based Monitoring – Beyond Theory In-Depth ReviewMarch 13, 2014
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Earlier this month, we hosted a webinar supported by MAPI on the topic of Risk-based Monitoring Tools for Application. It is now available for on-demand viewing at www.appliedclinicaltrialsonline.com/application
The webinar presenters were Laurie Hensley, RN, MSN, CCRA, Senior Group Leader, Clinical Operations, North America and Bill Row, Sr. Director, Clinical Operations Americas, who devoted time to discuss practical approaches for implementation and measures of success, and focused on key-risk indicators, tools for completing a risk-based assessment, Risk-based Monitoring Plan, and ongoing efficacy measures. MAPI case studies were also a part of the presentation.

As you can imagine, there are many questions and concerns around Risk-Based Monitoring and this webinar showcased that with many questions coming from the viewers. We didn’t have enough time to get to them all, so Hensley and Row provided answers to some of those questions below.

Q: Based on the case studies, I understand that the trigger to go onsite is based on evaluation of the CRA (subjective)? Is this correct?
A: Triggers for onsite visits are based on both subjective and objective measures.  An example of an objective trigger would be noted data abnormalities. Triggers could also be related to pre-defined parameters related to site subject enrollment projections (high or low).

Q: How complex should a risk-based monitoring frequency plan be in terms of selection of the amount of SDV and the sites to be monitored?
A: The Risk-based Monitoring Plan should adequately describe the monitoring approach that will be applied to the study. Recommended components of the Plan are outlined in the FDA Guidance document.

Q: Do you think that if sponsors want to utilize RBM, protocols will be written differently or sites will be selected differently? Will RBM become the driver for some of these processes?
A: A risk-based assessment is typically performed following completion of the final protocol but can also be completed on a preliminary draft.  Although recommendations may be made for drafting a protocol to minimize the need for onsite monitoring based on the level of risk posed by KRIs, it is not expected that risk-based monitoring will be a primary driver of the final protocol.

Q: Who is responsible for the creation and approval of the RBM plan for use? The sponsor or the CRO?
A: As with all study plans, the Risk-based Monitoring Plan is developed as a collaborative effort between the CRO and Sponsor with mutual sign off. 

Q: How would we use central data monitoring to decide or determine KRIs?
A: KRIs are assessed proactively during operational planning through examination of the protocol.  Central data monitoring is a component of the comprehensive risk-based strategy whereby we implement review of site-level and aggregate data to check for trends and outliers that may warrant further examination. 

Q: Do you have any budget examples (non-RBM/RBM) for any of case studies?
A: Risk-based monitoring is more cost effective than traditional on site monitoring with 100% SDV, but cost is not the primary driver behind the recommendation. Budgets for the shown case studies are not available.