StarBRITE offers quick answers and support

Links CR staff to everything they need

Call it a one-stop clinical research shop. An intranet web site, called StarBRITE, developed at Vanderbilt University in Nashville, TN, gives clinical research (CR) coordinators, investigators, and other research staff immediate access to clinical trials support information.

"It puts information in a central location," says Gail Mayo, RN, a research services consultant with research support services at Vanderbilt University in Nashville, TN.

"It provides a place for [CT] support staff to put things for research staff to access," Mayo says.

"I'm an education coordinator, and from the educational perspective we have a combined education calendar listing for five to six different groups," Mayo says. "All of their education sessions are listed in one place."

The idea for StarBRITE came from the process of applying for a clinical and translational science awards (CTSA grant), says Paul A. Harris, PhD, director of the CTSA biomedical informatics operations and a research associate professor in the department of biomedical informatics at Vanderbilt University.

"We virtually looked at all aspects of the research organization to find out where we might do a better job, and one area we thought we might improve was in supporting researchers," Harris says.

The idea was to create an electronic portal to assist researchers in finding and connecting information, Harris adds.

"We didn't want to reinvent the wheel," he notes. "Like most academic institutions we have pretty good IRB systems in place, a good contract system in place."

However, there are programs that don't reach their potential, and there are duplication efforts among administrative units, and these problems could be resolved through an electronic portal, he adds.

"We thought that if we built this portal for researchers and their teams and keep it as thin as possible, it would work," Harris says.

So far, the project has been successful with between 30,000 and 35,000 web page hits within the first five months and 1,200 unique users.

Researchers can go to StarBRITE to link IRB system data and clinical research data, extracting the relevant information that they need for their day-to-day work, he explains.

"It's leveraging data across multiple entities with the idea being that we want to deliver to the researcher just-in-time information for doing their jobs today," Harris says.

StarBRITE also lists funding request programs, and it updates staff about policies and procedures.

"In the fall, we'll develop a new set of procedures for study monitors/industry monitors/CRAs to gain access to confidential information," Mayo says. "So when they come from industry to monitor studies and gain access to confidential information, we can make sure it's all done appropriately."

StarBRITE gives the CT site a place to put this new information, Mayo adds.

The web site also provides a template for developing customized action plans (CAPs).

"It asks investigators a series of questions; they answer them, and it helps them determine which application processes they need to move forward for approval of their study," Mayo explains.

This includes IRB approval, biosafety committee approval, etc., she adds.

"StarBRITE helps investigators determine which application processes they need to use," Mayo says.

For example, Vanderbilt has a program that provides seed funding to investigators for pilot studies that could lead to bigger projects funded by government or industry grants, Mayo says.

"The whole program is hosted in StarBRITE," she explains. "It's an amazing portal where investigators and staff go to this one place and find resources that support everything from funding to application to data collection."

StarBRITE is more than a portal with a bunch of links, however.

"There are sections that are just informational in content with static content to show researchers," Harris says. "In many cases, we see the need to build down deeper in functionality."

For example, one of the deep components of StarBRITE is the REDCap database system.

"REDCap is a great tool," Mayo says. "It makes data more reliable and gives you a better vision of where you are with your study and the data you've collected."

Since REDCap was created by research and information technology experts, it's a better system for data collection and data analysis than a system that most investigators would create for themselves, Mayo adds.

When researchers and staff first take a look at StarBRITE, they see a colorful screen with button links for research planning and implementation, templates, and other information.

There's a link to a registry where people can sign up for Vanderbilt research studies, and there are links to various funding sources, including the institution's pilot funding mechanism.

"The piece on-line is a micro-grant or voucher where a researcher who needs a little money to see if the concept will work can apply and take it to the next level," Harris explains.

"On StarBRITE, the researcher can find out right now what he needs to do to obtain funding within Vanderbilt," he adds.

The data management link takes one to REDCap, and educational resources provide information about academic workshops involving research, Harris says.

A governance dashboard provides information about registry and REDCap utilization to a select group of users, Harris says.

"The voucher dashboard allows us to look at who is using the voucher system, what level in any month of applications is provided," Mayo says.

The biggest challenge StarBRITE has presented is getting out the word about its features and availability, Mayo notes.

"The big challenge has been getting out the word to investigators that they can look in one place, instead of many different places, for information," she says. "We've done grand rounds and staffing group demonstrations to help them understand they need to take time to investigate it."

Ultimately, the goal is for everyone in the research community to use the portal, Mayo says.

"This is the place that the staff and users can come to for an initial evaluation of their research," Mayo says. "They won't have to search throughout the whole Vanderbilt system to find answers to their questions and needs."

Instead of contacting individual departments, researchers can get on-line and find roadmaps and plans that will help them through the research process from beginning to end, she adds.

"Also, the [research] staff have the ability to access information promptly by going into StarBRITE instead of calling us up with questions and having us send them documents," Mayo says.

For example, if the study will require study monitors to access confidential information, then the study coordinator can go onto StarBRITE and find out step-by-step the details of what needs to be done, she says.

"This allows us time for other projects, like developing more tools and templates," Mayo says. "It should, hopefully, shift and change our roles as support staff."