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Weekly RBM Feature: A Risk Flower – what is it?

Weekly RBM Feature: A Risk Flower – what is it?

Weekly RBM Feature: this is a series of articles, where we want to describe some innovative RBM features and our approach in dealing with analysis, presentation, and mitigation of risks in clinical trials.

To anyone “in the know” of the main purpose of the EarlyBird RBM system it should come as no surprise that it offers a way to work with study drafts created through the Risk Assessment and Categorization Tool (or, for brevity’s sake, RACT), but there is one problem: the visual representation of these assessments.

Typically, if you wanted to look at all the risk assessments in a study, you would see a long list consisting of dozens of positions. While informative, such a presentation means that it’s immensely difficult to keep track of all the assessments at once, and therefore it’s also all but impossible to form a cohesive, accurate and yet brief picture of them all in conjunction.

Luckily, there is a way around this. Enter the Risk Flower Chart, a simple way to represent the assessments in one small, easily digestible image, with a ton of customization options to boot. In its simplest way, the Risk Flower Chart looks like this:@RACT Risk Map 1

There, each of the circles (or “petals”, or “bubbles”, whatever you’d like to call them) represents a single category (a group of RACT questions), with its size representing the risk score of the category (calculated from its questions’ risk scores), and its color representing the resulting assessment (low, medium or high risk).

Thus, just from a brief glance at the chart, we can already see the proportions of various assessment levels, the categories with the highest and lowest risk scores, as well as get a picture of risk score distribution in general, something that even a short list of categories wouldn’t make simple.

But what if we went deeper? Let’s customize our chart a bit to make it even more informative:

@RACT Risk Map 2

Here we add one additional parameter: category weighting. It is represented by the opacity of the circles, i.e. the less weight a category has, the more transparent its color becomes on the chart. This is incredibly simple, yet this is what makes it so useful as an effective visual representation.

We can add more details, too. Let’s say we want to dive down a level and how the questions’ assessments, or even individual risk assessments. The Risk Flower Chart allows this too:@RACT Risk Map 3

This version displays each risk assessment for every question, grouped by categories (shown as gray circles). For simplicity’s sake, the risk score in this example is no longer displayed through size, instead only the risk assessment/color link remains (though if the need arises, this could, of course, be returned, just as the weighting could enter the picture again). Do not be dismayed, though, in its absence you can still easily see the specific risk score by just mousing over the circle representing the risk:

@RACT Risk Map 4


The great thing about this way of representing your study is that you can see every individual risk assessment, and get a picture of the overall category risk assessment, and see the distribution of risk assessments within the category all at once, without having to navigate through any lists or comparing rows in some table to each other.

So, this is the first feature in our Weekly RBM Feature series – the Risk Flower Chart, a simple yet elegant, flexible and highly customizable way of representing your RACT versions’ risk assessments.


By | 2017-05-09T16:23:54+00:00 May 9, 2017|Weekly RBM Feature|1 Comment

About the Author:

Professional in the integration of data-driven Risk-based Monitoring (RbM) process in international clinical trials of pharmacology. Speaker at regional and global conferences such as: DIA, PharmaForum, PharmaDay, DGGF, etc. 10+ years of experience in data quality projects and biostatistics for the pharmaceutical industry. Life passion: improving clinical research with RbM, driving the RbM research to new frontiers for CROs, pharma and biotech companies.

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