The Oracle’s Perspective on Risk-Based Monitoring

As the clinical trial enterprise becomes acquainted with the concept of Risk-Based Monitoring (RBM), it brings with it modifications to the task descriptions of Data Managers (DM) and Clinical Research Associates (CRA). While we become empowered with the technological enablers of centralized and statistical monitoring, it can be challenging to envision the respective functions of DMs and CRAs. In fact, if we take into consideration the objectives of improving quality, cutting costs, and complying with Good Clinical Practice, the tasks assignment to DMs and CRAs within a risk management strategy can involve a fair amount of uncertainty.

When facing unsolvable uncertainty, it is wise to switch perspective. One may do so by seeking counsel from an ancient decision support system: the I Ching aka the Book of Changes. Using its hexagram-based divination, we can probe the unconscious and acquire useful viewpoints; so let’s summon the oracle and receive some wisdom on RBM. 

Asking the question “What do I need to know about RBM?”, I flip my coins and I get Hexagram 3: Chun.

The oracle’s judgment of this hexagram reads as follows:

Difficulty at the beginning works supreme success

Furthering through perseverance

Nothing should be undertaken

It furthers one to appoint helpers

I can relate the first line to the confusion one is bound to experience when approaching the multifaceted concept of RBM and the inevitable hardship one must transcend to change cultures typically refractory to change.

The second part states that nothing should be undertaken and the oracle also specifies that a premature move might bring disaster.  This emphasis on the importance of careful planning is also supported by the classic Plan-Do-Check-Act (PDCA) risk management framework. Identifying risks early in the trial design process allows one to plan for mitigation actions using the skills of DMs and CRAs. Moreover, as one plans and performs a risk assessment, one will gain depth and realize that with respect to RBM, “risk” stands for “risk to quality” and that quality relates to data, subject safety and trial integrity.

The last part states that itfurthers one to appoint helpers. So who’s to help DMs and CRAs? Well, perhaps they could help one another. The oracle also advises that one must be able both to separate and unite. I reckon this means that some of CRAs’ tasks, including SDV, represent portions of the risk management process which can be better handled by DMs with the vast amount of data they have at hand. In fact, as quality management shifts from on-site monitoring to central monitoring, the new monitoring paradigm stresses the role of DMs in the execution of the DO and CHECK steps of the PDCA cycle including the computing of key risk indicators, their ongoing analysis and their reporting to clinical operations. Moreover, DMs have tools such as automatic edit checks to ensure data quality so that it doesn’t require as much verification by CRAs. On the other hand, CRAs are in the best position to interact with sites’ personnel and perform the review of sites’ documentation and processes. CRAs are thus essential to manage quality areas that do not have data fields available for central monitoring. Regarding the ACT step of the PDCA cycle, CRAs can perform hands-on risk mitigation more efficiently when vested with the information generated by DMs. They can also yield qualitative measures of sites quality which are of use to DMs in their computation and analysis of site-specific risks.

So what does this mean for you? DMs and CRAs must work together as the complementary forces of Yin and Yang to complete the PDCA cycle and fulfill RBM’s “promise” of higher quality and less costly treatments. Only then will you achieve supreme success.

Adam Beauregard, BSc, MBA, CCRP, CCDM, RAC, is Data Manager for EndoCeutics Inc.
adam.beauregard@endoceutics.com
 

For more tangible insight and strategies on how to achieve success when implementing RBM into your organization, join me at CBI's Risk-Based Trial Managmenet--is it only about monitoring?, this November 5-6 in Philadelphia.