Key Risk Indicators – The Vital Few

Risk-based monitoring (RBM) has gradually evolved into holistic risk-based quality management (RBQM). The cloud has made centralized monitoring of all risk-related trial factors a seamless reality, wherein Key Risk Indicators (KRIs) play an important role.

Risk Based Quality Management (RBQM) supports study teams with making timely safe and sound decisions, and revolves around 5 questions:

  1. What might go wrong?
  2. What is the likelihood that it will go wrong?
  3. What are the consequences?
  4. How easy is it to detect?
  5. How can it be resolved?

A risk indicator can be any metric used to identify your risk exposure over time. It becomes a KRI when it tracks an important risk, or does so especially well because of its predictive value.

KRIs in clinical trials could be safety, performance or financially driven. They could contribute either marginally or substantially to the identification of a risk. Some Key Risk Indicators are more frequently being used than others.

What makes a good risk indicator?

Ideally you want the indicator to be relevant, measurable, predictive, easy to monitor, auditable, and comparable.

KRI Modules Available in Cyntegrity’s MyRBQM® Portal

Each of the KRI modules holds a set of carefully selected and validated key risk indicators, and are all 21 CFR part 11 and GCP compliant.

Data quality is the next stage after the fraud check. This KRI set can identify systematic factors, which influence the precision of data capturing. KRIs fire an alarm, when, e.g., data has unexpected distribution or has too low variance.

Performance of a clinical trial is the complex topic. It can mean performance of sites, central labs or even performance of data management department. This KRI set focuses on patient recruitment questions. It builds a mathematical model of including in a trial and can already in 1-3 first month forecast with 80% of probability, how good the performance of recruitment will look like.

How good your CRF covered? What proportion of missing data is inside?

The quality of data, speed of data transfer, proportions of missing information influences the site quality benchmark.

ECG Lead misplacement, too high signal noise in ECG, signal defects, etc. could be identified by these modules.

Bad Calibration, errors by measurement taking

How good is your Spirometry measurement? Does it fit into latest ATS criteria? Was certain event (like coughing) disturbing the quality of taken maneuvers?

Was a patient attentive while filling up a questionnaire? Is the data trustworthy, does integrity exist?
Do you have some risk, you would like to control in the upcoming trial?
Did you have any risk event in the past, which you would like to avoid in the future? Tell us and we realize them in a KRI.

Each KRI is tested based on retrospective methods using real and artificial data. The KRIs are developed based on the most recent industry standards and with the support of industry experts and key opinion leaders as well as our own internal “KRI think tank”. Our KRI think tank consists out of academics with substantial field experience either as CRA, lead CRA or clinical project manager.

Let’s discuss your needs!

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