In switch to electronic technology, learn QI from CR coordinators

Those in the trenches often know best

One of the lessons Rush University Medical Center in Chicago, IL, learned as the research site spent more than four years transitioning to an electronic process was that sometimes coordinators really do know best.

"It's interesting, because the observations study coordinators had were about how we could implement the electronic process in a much more thoughtful way for our users," says James L. Mulshine, MD, a professor in internal medicine and an associate provost for research at Rush University Medical Center in Chicago, IL.

"Investigators look at data from the regulatory perspective, but coordinators have a complementary, but different perspective on the nuts and bolts of what's going on," Mulshine says.

Both perspectives need to be taken into account as a research site transitions to electronic documentation and activities.

"Coordinators are grounded in knowing how documents traverse the review process," Mulshine notes. "Coordinators are very attentive to the fact that they have to know every second where that protocol is in the process."

Investigators see the process from the macro level and leave the day-to-day transit issues to coordinators and the IRB.

The important thing for research sites is that they can count on coordinators to assist with checks and balances during the pre-initiation of research process. Coordinators will attend to data capture and capability issues, tracking a protocol's review process with the IRB, as well as with scientific and other boards.

Also, coordinators will stay on top of budget approvals and other issues. So if they discover the new electronic process is flawed or bogged down in some area, they'll let an institution know that some adjustment should be done to the new technology.