Over the last couple of months I’ve noticed a subtle but important change in the RBQM conversations I’ve been having with clients and potential customers. The pandemic has made even the biggest sceptics realise the importance and benefits of remote and central monitoring. If CRAs can’t travel to site, what else is there? But the conversation has moved from “My Senior Managers don’t buy into it” to “RBQM yes, but how…” That subtle shift is good because it means people are now really starting to think about the practical aspects of implementing RBQM.
The most common question I’ve heard is “How do I document it so that it’s RBQM compliant?” For example, one customer said to me “I don’t need your help with the data – I’m a statistician. But how do I document this issue so that it’s meaningful”.
The answer is “it depends”. One of the biggest challenges we have is getting people out of their prescribed ideas and entrenched views. They worry too much about what an auditor or regulator might think when reading comments, and not enough about what the data is actually telling them. It’s more important to have 'minimum inspection standard' and work around that based on what the data tells you. For example, you might decide that every site is going to get two visits a year as a minimum. You’d then only visit the site if the data is telling you something is wrong and needs attention.
To help people think these things through I’ve developed a conceptual framework I’ve, in a fit of originality, called the 3 C’s – Context, Critical Thinking and Communications.
CONTEXT – Ask the obvious questions like: what was the monitoring plan for this activity; what was reviewed; what was observed; what action was taken (if any)? Documenting those simple questions will take you a long way, but it’s surprising how many don’t do it.
CRITICAL THINKING – Another way of saying use common sense. For example, if you’re running a study with a small number of patients, don’t get too excited if after month two your dashboard looks a bit odd. You just don’t have enough data yet to come to conclusions. (You might think this is a trite example, but it happens often).
COMMUNICATIONS – Who needs to know what by when? What information needs to be shared, by whom, when and why? What decisions will be made using the information?
It’s a very simple, but highly effective way of getting past that mental block of “How do I document it so it’s meaningful”.