RBQM Ops 2022 - Day 2 Intro and Central Monitoring in Early Phase Trials

Intro to Day 2 and Central Monitoring in Early Phases

SUMMARY KEYWORDS
monitoring, data, site, central, qm, rbqm, patients, risk, study, trials, phase, early, presentations, important, cra, stv, protocol deviations, questions, session, adoption

SPEAKERS
Duncan Hall, Nicole Stansbury

DUNCAN HALL:
Well, hello, and welcome to day two of RBQM operations 2022. I'm delighted you could join us. Thank you for taking time out of your busy schedules to attend today. Now, if you were here with us yesterday, I hope you'll agree we had a great set of speakers sharing some really interesting and genuinely valuable insights. A couple of things really stood out for me yesterday. The first was that there's really no right way to do RBQM. Each study needs to be taken on its own merits, and the degree to which RBQM applies, really needs to be determined and planned in on a study-by-study basis.

We hear that the regulatory agencies are willing to support companies that are implementing RBQM by reviewing their RBQM approach before study starts, or before the RBQM component of the study starts. But they didn't expect that approach to be presented. And they're not, they're not going to create that plan for you, but they will review them and give guidance. Other thing was that the complexity of studies is clearly increasing with new approaches, new technologies, more data being collected than ever before. And the management of the risk around those changes needs to be managed really closely. And, and because of that, RBQM becomes even more important going forward.

Now, at the end of the day, we had a really interesting and lively panel session, which I really hated to end after an hour, I think we really could have gone on talking all evening, we had representation from some large Sponsors, WCG, industry body and the technology vendor as well in the DCT space. And there are a few really strong themes that came out of that conversation for me.

The first was that that risk identification and management is really where the regulatory focus is right now. And the second is that the ongoing management of risks to quality and safety is the responsibility of multiple functions within the organisation. And it's not just those people with monitor in their title, who are monitoring. So, it's a cross functional multi discipline, activity. And many, many people have responsibility for the monitoring of that data during the data lifecycle in the and the trial lifecycle.

Now, there's clearly still confusion over terminology, in the RBQM space, and we really need to agree a more common language for industry that doesn't change from company to company, so people can move around the industry as they tend to do without constantly being confused about what things mean. So, if yesterday's session was full of great content, today's promises to be just as good. And we're going to be moving on to tackle some new issues in the RBQM space, the first looking at RBQM in early phase trials, then we'll be looking at identifying patients at risk. And then finally looking at the organisational change that's required for RBQM to be successful within a business...