Lenis Sosa, MSN, RN, CCRC, Houston Methodist Research Institute
Even the most change averse clinical trial practitioners can warm up to managing clinical trials in new electronic environments if the benefits are demonstrated early and often, says Lenis Sosa, MSN, RN, CCRC with the Houston Methodist Research Institute in Texas. It’s a big challenge because transitioning from paper to electronic files in clinical research not only causes concerns related to subject information and trial data confidentiality, it also creates new challenges related to managing a multitude of systems, Sosa says.
At Houston, Sosa and team have implemented an electronic health records system, EPIC, that has streamlined communications with the clinical side of the operation so his team can readily see which patients are enrolled in research, and efficiently flag what patients invoices are research or clinical in nature.
Nurses, researchers and others conducting the trial in a new electronic environment will be less resistant to change if you can give them a clear visualization of the project’s goal and what that change will ultimately mean for them on a day-to-day basis, he adds. He advocates training sessions planned well in advance. It’s also important to adjust training to different audiences. “I’m a nurse, and we’re taught to do assessments with open-ended questions,” Sosa says. He uses some of that same skillset as he designs educational presentations for his own staff and more broadly across the entire hospital system.
In addition to navigating the all-important human factor, it’s also critical to be well-versed in the latest developments in US and EU regulations and guidance documents covering the management and use of electronic tools in clinical research, experts say.
Ultimately, training should be scheduled well in advance of any implementation, strive to be entertaining, and make it clear to wary users how it will make their job easier and more efficient, Sosa says. “You don’t want to surprise anyone,” he adds.
Learn More
For more tips on managing the transition from paper to electronic files in clinical research, check out eResearch: Managing Clinical Trials in an Electronic Environment.
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