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eSource, RBM, and Breaking Free of SDV

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In clinical research, data accuracy is a top priority. That’s why the advent of electronic data capture (EDC) in clinical trials has illuminated the importance of source data verification (SDV), the process of comparing data entered into an EDC to its paper source to ensure consistency. Recently, risk-based monitoring (RBM) has emerged as a popular method of optimizing this process. But in an era of boundless eClinical technology, there’s more than one way to achieve this task. Researchers have options and can attack their challenges from several different angles. We see eSource as, among many other things, an alternative to RBM for alleviating the burden of SDV. 

What’s RBM, and Why Does It Matter?

Risk-based monitoring basically entails identifying which aspects of a clinical trial pose significant risks to data quality and focusing monitoring efforts on those aspects. This process requires only partial SDV – its proponents argue that it not only makes monitoring more efficient but better protects patient safety as well.

It’s hard to argue with this rationale. There’s pretty compelling evidence that the alternative to RBM – performing 100 percent SDV – is grossly inefficient, both from a financial and timeline perspective. Studies have shown that only about three percent of data corrections are a result of SDV.1 SDV, meanwhile, can comprise up to a full 40% of a trial’s budget.2 Amid rising drug development costs, this is an expense no company, especially those of modest size and budget, should have to bear if they don’t have to. 

The eSource Way: No Paper, No SDV

But what if RBM wasn’t the only way to take on the burden of SDV? At Medrio, we’ve found that eSource, in addition to catalyzing data entry and data sharing, is a great way to eliminate SDV using a simple tablet application. eSource, by empowering researchers to capture data electronically right at the source and sync it directly to their EDC, has been heralded as the long-awaited technological innovation that will get paper out of clinical research once and for all. And by eliminating paper, eSource has also eliminated the need to transcribe data from paper to EDC, the very process that makes SDV necessary. We’ve taken this even further, applying the same technology used for paperless clinical data entry to processes like patient-reported outcomes and informed consent. 

Conclusion

Clinical research today is an expensive endeavor, and a lot of researchers are trying to achieve big things on limited budgets. The last thing they need is to spend a major portion of that budget on a process that can be essentially eliminated with the right tools. The good news is that, with RBM and eSource, those tools are readily available.

 

  1. https://www.clinicalleader.com/doc/new-fda-thinking-on-risk-based-monitoring-0001
  2. http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0081890

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