As on-site monitoring continues to dwindle, collecting quality metrics is no longer the sole province of the sponsor. Sites are stepping up to focus on risk management and quality that matters.

“In GMP, [companies have] done risk management for years, but in GCP, [sponsors] haven’t. [Sponsors have] had this idea that you have to inspect everything in terms of when you go into a site, a monitor’s got to make sure every data point is correct, this kind of thing,” says Linda Sullivan, executive director of WCG Metrics Champion Consortium (MCC). With sites across the world, “trying to maintain that kind of an approach is not feasible. It’s not scalable.”

To help sites get a handle on what metrics they should be collecting and how, MCC has developed a metrics set designed to help them identify key performance indicators and critical success factors that help organizations choose the right metrics for a particular study. And recently, it’s published a toolkit for use by sponsors/CROs in measuring new approaches to monitoring.

The toolkit contains 20 metrics: five basic metrics that all organizations should mull over, eight advanced metrics that can be used for further analysis and three “aspirational” metrics that MCC believes are valuable but ultimately not measurable at this point by most organizations. Four additional metrics are still under review, Sullivan said, and the consortium plans to add them to the toolkit in 2022.

As sites continue to take on quality tracking, they also are taking on more of the responsibility of being prepared for audits, says Jill Heinz, president of Family Care Research.

“In addition to our own internal quality assurance checks, a monitor coming onsite helps make sure we’re audit ready,” Heinz said. “So, as it’s shifting more to remote or risk-based monitoring, sites really have to step up their game if they haven’t already to ensure we’re audit-ready on all data points. That means quality management systems, tracking metrics, etc.”

Sponsors and CROs can help by making broad quality benchmarks available to sites. If monitors are not coming onsite, she said, they’re looking at the database and flagging certain outliers or trends.

“That’s never shared with sites so that we can also kind of go, ‘oh, we’re trending in a different way than most sites; what are we doing that’s making us an outlier? How do we improve it? How do we use that opportunity to get better?’” Heinz said. “I’d love to see the information go both ways. Sites are always giving data to study sponsors and CROs, but I’d love for them to offer to give us feedback as well.”

Right now, metrics are mainly shared with sites that only include patient enrollment numbers — nothing on protocol deviations, queries or other areas, according to Heinz. This kind of information, such as the most common protocol deviations among sites or what a site is being queried on the most, could help sites learn and react to other sites’ mistakes, Heinz said.

For example, a sponsor may send a site three queries about data after monitoring. But it would be helpful to learn how those three queries stood up to the performance of other sites in the study. Did other sites get 30 or 40 queries, for instance, or none at all?

Real change is likely to occur when the issue starts hitting the trial budget and sites seek funding to adjust to remote and risk-based monitoring, Heinz predicted.

“When we’re doing contract and budget negotiations, it’s assumed a site is going to give a sponsor quality data,” she said, but it was also assumed that the site would be monitored onsite every four to six weeks. “Without that, we need to make sure we’re filling that gap in at the site level. That’s extra work, extra time. I think if sites start waking up to, ‘boy, I really should start putting this in my contract to reimburse for that time or that quality check on the source data that we’re not getting anymore,’” things will start to change. “When it [goes] into the money aspect, it tends to push things along.”