Compliance Corner

CR site process optimizes workflow, reduces delays

Simplify timelines, follow best practices

If your research site has not tackled the issue of optimizing its workflow and reducing the number of study delays, then now is the time to do so.

This is a process that can be done with incremental improvements and trial and error, says James L. Mulshine, MD, a professor in internal medicine and an associate provost for research at Rush University Medical Center in Chicago, IL. Mulshine was a moderator for a forum on translational research and reducing regulatory burdens at the Research Community Forum 2010, sponsored by the Office for Human Research Protection (OHRP), and held May 21, 2010.

Clinical research (CR) sites can improve their overall trial process by simplifying timelines and following best practices, he says.

When the goal is to move novel clinical practice to the research arena and then back to standard clinical practice, a more efficient research enterprise is crucial.

"What we're trying to do is broaden the discussion so there's an understanding that at academic medical centers there is a core mission to improve health outcomes related to health care delivery," Mulshine says. "And discovery is fundamental to what many people expect from an academic medical center."

To improve a CR site's workflow, one strategy is to use electronic tools to help expedite the process and improve documentation.

Rush University Medical Center uses a web-based software tool that supports IRB processes, grants, related administrative processes, and contracts work, Mulshine says.

"Four years ago we did due diligence, looking at these types of tools and anticipating the development of a web-based process," he says. "We looked at all of the functions we were committed to putting on the web, and we identified all processes."

The goal was to create simplified workflows that would help in the implementation of the electronic tool, he adds.

The research site used the electronic tool to move its processes from paper-based to web-based.

"We went through every process having to do with IRB submission, grant submission, and research contracting to try to figure out the most efficient way to do all of these things," Mulshine says.

"There were many moving parts, and I can't say we're perfect, but we did greatly simplify an enormous amount of our activities," he adds. "And we implemented those simplified workflow processes using these software tools."

The result is the site now has a web-based environment that incorporates all activities from managing protocol submission, required ongoing reporting, and grant submission to the National Institutes of Health (NIH) or the U.S. Department of Defense.

"We've been developing the system for four years, and we're maybe at 75%," Mulshine says. "We keep building."

The benefits of moving to an electronic system include the following:

• "We provide portable computers to staff, and they can do the work electronically," Mulshine says. "Minutes can be distributed much more rapidly, and all dates of document submission, approval, what's received, what's submitted, and all notable points are now captured and can be scrutinized by anybody across the institution who is involved in that process."

• The timeline for completing the protocol submission, review, and approval process has improved. Previously, paper documents would move physically from one desk to another and then sit in piles, sometimes getting lost, Mulshine notes.

"No one knew where they were," he adds. "The electronic system eliminated all of that ambiguity."

• The environmental system saves paper, time, and money by eliminating the process of making 20 copies of a protocol or protocol changes.

"All of that unproductive labor over the process of a year went away," Mulshine says.

• When Rush applied to NIH for the fast-track grants available through $10 billion in national stimulus package funding for research, there were tight deadlines creating bottlenecks, Mulshine notes.

"There were problems with volume relative to NIH to receive all these things," he says. "By having the electronic system, we had a direct point-to-point transit system to NIH that voided a certain amount of traffic jam and allowed us to be very efficient, ensuring our grants were submitted in a timely fashion."

So Rush didn't get caught in the application gridlock and did very well in terms of awards, he adds.

"We won grants on faculty development, grant supplements to existing projects, instrumentation grants, grants to do very focused things to enhance goals, and a whole array of things enabled by the stimulus funding," Mulshine says.

The electronic infrastructure allowed the institution to handle the grant process very efficiently with minimal stress on faculty, he adds.

As research sites increasingly move to electronic processes, they should make certain investigators, coordinators, and other research staff are fully invested in the change.

"At the time we started doing this, the product had been used in 14 to 15 institutions, and we took advantage of the best practices from that previous experience," Mulshine says. "We took the best version and sat down with coordinators, investigators, and administrators to talk about how to accommodate the generic version to meet the needs of investigators at Rush."

It was important to engage research staff in helping to define processes and adjusting these to meet the specific needs of the facility, he adds.

For six to 10 months, the new process was handled as a voluntary compliance change. Once it was fine-tuned and made more efficient, the staff who had been early adopters of the technology helped spread enthusiasm and interest in the technological change.

"Good word of mouth helped us transition this uniformly throughout the campus, and the process went quite smoothly and rapidly," Mulshine says.