Software Solutions

Electronic system shows potential for CR site

CR field integrates with eIRB

Washington University School of Medicine (WUSM) in St. Louis, MO, is in pursuit of an efficient, integrated, and comprehensive electronic communication and information system for every step of the research process.

The institution is very close to a goal which could become a model for clinical research (CR) sites seeking an electronic solution to improve the CR process.

"We're still in the development process of a clinical studies management system (CSMS) that was started in February, 2007," says Sara Kukuljan, BS, RN, CCRC, director, Center for Applied Research Sciences at WUSM.

"We initially pursued this for billing compliance needs," Kukuljan says. "We are co-developing with Johns Hopkins University, who had started this project two years earlier with mdlogix."

The project which is being developed with Medical Decision Logic Inc. is still under development, and pilot groups have recently been selected, she adds.

"This system will integrate with other systems at the university, including the eIRB and the financial system, the hospital, and physicians," Kukuljan says. "The system will be used for clinical studies, and it will help the investigator manage the study from the start to the finish."

Included in the system are modules involving subject recruitment with a database of research volunteers; a subject and protocol registry that has study demographics; subject screening and informed consent information; protocol schema and patient calendar, which has a detailed protocol schedule of events and research volunteers' scheduling calendar, and case report forms, including electronic forms that can be integrated with clinical result systems.

Here are some examples of how the system will be integrated with various CR functions:

• Financial module: When investigators and the CR site are trying to decide the feasibility of a protocol, the financial module will make this an easier process.

"The principal investigator (PI) can build out the protocol's schedule of events, and the system automatically will build out the budget," Kukuljan explains.

"We've loaded the system with chargemasters and research pricing and all procedures, including over 14,000 CPT codes," she adds. "So PIs don't have to call individual departments for pricing."

The system has forced everyone involved in research to agree on prices and it puts all of the financial figures in one place, she says.

Once the financial module provides a PI with pricing information for a particular protocol, the PI can decide whether the protocol will be financially feasible, Kukuljan says.

If the answer is "yes," then it's time to move to the next step in the process.

• eIRB: PIs will be able to submit IRB applications electronically, and, eventually, the CSMS and eIRB systems will be linked, Kukuljan says.

When investigators move between the CSMS and eIRB systems, they will have to populate the data fields only once because the other system will pull up the information as it's needed, she explains.

"We've recently joined forces to get the CSMS and eIRB projects moving forward because we'll have such close interactions within the two systems," Kukuljan says. "They're working parallel with each other."

• Electronic applications for all review bodies: The eIRB is a Smartform, which is a term coined by Click Commerce to describe their application that can consolidate several different forms into one form with several sections and "branch submitters" to the applicable sections.

Washington University in St. Louis (WUSTL) developed a "hide/show" feature that shows applicable questions within a Smartform section, based on previously answered questions, says Diane Clemens, DC, CIP, an eIRB education specialist at WUSTL.

"Combined, these two technologies can significantly reduce the length of an IRB application," Clemens notes.

"There are trigger questions for all 34 ancillary bodies at the university," Clemens says. "If investigators indicate they'll do research in a neonatal intensive care unit, then that will trigger an application to be sent to the NICU review body."

This way, PIs can complete one eIRB application and all of their review applications will be automatically generated and routed to the appropriate boards, she adds.

Investigators, IRB members, and others in research acknowledge that the new electronic systems will be a great benefit to the research process and will save PIs and IRBs time, Kukuljan and Clemens say.

"PIs are thrilled with the concept of it, but like many of us, they don't like change," Clemens notes.

As the system's construction continues and a roll-out is planned for later this year, the CR institution is developing a communication and training plan, Kukuljan says.

"There will be different phases of training," Kukuljan says. "This type of system will impact everyone's workflow, so we'll have to go to each department and discuss this with them."

The training will be based on these discussions and each department's particular workflow, she adds.

"It probably will be a year-long process, and we'll also have a continual type of training process," Kukuljan says.