RBQM Ops 2022 - The Top 10 KRIs

Top 10 KRIs

SUMMARY KEYWORDS
site, participant, AEs, study, reporting, serious adverse events, protocol deviations, PDs, rate, queries, protocol, high, visits, number, data, type, discontinuing, trial, primary drivers, assessments

DUNCAN HALL:

One of the questions we get asked time and time again is which key risk indicators or KRIs should we use for our study? And who better to talk on this subject than a person who has developed more than 40 KRIs for the KRI library in our own RBQM technology platform OPRA. Laura Illingworth is our in-house statistician. She's worked on many of our large RBQM implementations developing both bespoke KRI dashboards for particular studies, as well as using the KRIs from our KRI library. Now, she's going to be focusing on her top 10, and tell us why those KRIs give you the best overarching view of data quality in a clinical trial. Laura over to you. Thank you very much.

LAURA ILLINGWORTH:

Thanks for the introduction, Duncan, I'm Laura Illingworth and I work here at TRI trials and oversee the statistical parts of OPRA. Here's a standard disclaimer slide which I'm sure you've seen many times. And these views are my own, and I'd be happy to discuss these ideas and thoughts with you all. In the next twelve-ish mins, we are going to review our top 10 KRIs. There's been a balancing act of picking 10 KRIs. These KRIs have been chosen based upon our experience from central monitoring and a combination of our three primary drivers for central monitoring, safety, quality, and compliance. So on to the top 10 KRIS.

First up we have adverse events, followed closely by serious adverse events to assess whether the sites are reporting a similar number of adverse events or serious adverse events. Then protocol deviations or sites reporting PDs in a similar manner. Study discontinuations and screen failure rate. And this helps to check that a site is recruiting the correct patient population. Not done assessments and missing visits, we need to know that subject data is being collected. Data entry timeliness, are the CRF forms being handed in in a timely manner? Time to close manual queries and are queries being answered.

Looking at our three primary drivers of central monitoring, there is often overlap. For example, for adverse events, we can see that it's all about safety. Apart from we can sometimes also see that it's about the data quality that's coming in, are they correctly identifying AES, and also about compliance? Are they complying with the protocol and reporting AES in the manner that we want them to be registered.

And the same thing for protocol deviations. And we can go through all of these and see that some of these can be tied to safety, and compliance and data quality and they all work together to enable us to assess the sites...