Software Update: Clinical trial coordinators find MIT software useful

Goal is to make software easy to integrate

[Editor’s note: Clinical Trials Administrator continues the series on clinical trials software, looking at its use, potential, and availability. The software featured in this issue is COEUS, created by the Massachusetts Institute of Technology (MIT) in Boston.] 

The nine years that have gone into developing COEUS have resulted in software that research institutions may use, modify, and improve as they seek greater efficiency in data collection for research.

"COEUS brings core data from the study proposal and starts the set-up from the award process," says Stephen D. Dowdy, assistant director of MIT’s Office of Sponsored Programs, where COEUS was developed.

"For example, if you have a program project grant, and you need five investigators to have their own accounts to spend out of, COEUS has an award hierarchy concept that allows you to create structures and distribute money to multiple investigators and departments, and it holds it all together for you," he says.

MIT’s original intent was to create COEUS for its own use, and so the first module was the awards module, Dowdy explains.

But as the module was upgraded and enhanced, word got out, and research officials from other institutions began to ask if they could purchase a license to use COEUS, he says.

MIT charges $500 for the software, which gives the user all upgrades for free, and COEUS has been licensed to about 100 institutions, Dowdy says. "We’re not out to make money on it," he notes. "We’re more into setting a national standard or best practice."

Since MIT has no clinical trials program, COEUS does not have a clinical trials management module but it does have about everything else an institution would need to manage research, including proposal development, an award module, an IRB module, a conflicts of interest module, a subcontract module, and a negotiation module, Dowdy reports.

The awards module includes terms, conditions, contracts and report deliverables, and the proposal development module offers assistance with creating proposals, budgeting, system interface with the grants office, and routing research through the institution for signatures, he says.

The next step is to reach an agreement with one of the largest financial software vendors to integrate COEUS with that system so institutions that already have the other system could easily meld the two products’ strengths, Dowdy explains. "COEUS is not a financial system," he says. "When we get to that fine line, we say pre-award up through award management, but one of our driving principles is to not create a shadow financial system."

Research institutions that choose to use COEUS for some of their modules will need technical support, particularly if they’re new to Oracle, since the COEUS database is Oracle-specific, Dowdy says.

MIT will send information technology consultants to a site if requested at a charge ranging from $90-$150 per hour, he says.

"Some schools have a really good set of technical resources available, and we can generally handle it with phone calls and e-mails when they have trouble," Dowdy says. "And some schools want a SWAT team to set it all up and running and to have the skills to maintain it afterward."

Depending on how much data need to be migrated into COEUS, the start-up time could take a week or months, he adds.

Here’s a brief look at the features each module offers:

  • Proposal development: Multiple people can access this paperless system, and if a person in another department is needed for developing a budget, this assistance can be provided interactively on-line, Dowdy says.

"Most schools have a paper routing sheet for signatures, and that’s a linear, sequential process," he says. "With our routing system, the signing can all be done simultaneously if needed."

Also with the grants feature, the system will automatically send the proposal to the central office of the institution and to the granting agency when the proposal has been completed, Dowdy says.

"When you get to the end and it’s approved at the central office, then it’s automatically going into the federal government’s computer system," he explains. "There’s no re-keying of data and information."

  • Award module: Once the proposal is funded, COEUS brings its core data to the award process.

The proposal will have all terms and conditions loaded into the system, including data on who is the sponsor’s intellectual program officer, Dowdy notes.

"It also has a template; so when we get a routine NIH award, all routine research proposals have the same basic terms and conditions, so we select the NIH template and standard report with terms and conditions that are repopulated into that system for that one award," he says. "And occasionally, the sponsor may throw in an extra term requirement on one award so the template brings in the standard conditions, and you go to the screen with overrides and add in the extra requirement."

The award module also tracks all of the reports, including fiscal reports, intellectual property reports, and technical reports, listing when they’re due, Dowdy says.

"If you have a final technical report due 90 days after expiration, NIH and authorities allow us to give ourselves a no-cost extension so you don’t need to update all deliverables," he reports. "When you say, I’ve expanded my award for six months,’ they calculate all deliverables and reporting requirements automatically."

The system also tracks cost sharing and shows the approved equipment and approved travel.

  • Subcontract module: When the NIH awards an institution for a study, there maybe some portion of that study that the institution will farm out to another university, Dowdy says.

"So if I farm out a portion of the award to Harvard, then I become Harvard’s sponsor at that point in time," he says.

The subcontract module tracks who the subcontractors are, who the principal investigator is, and the administrative contact at the other institution, Dowdy notes.

"It shows how much money we have farmed out and how much money we anticipate farming out," he says.

  • Conflict of interest module: Institutions subject to conflict of interest regulations or their own conflict of interest rules will be able to see with this module what all relevant financial interests are for research faculty and investigators, Dowdy says.

"COEUS allows them to make disclosure and track financial entities that they are disclosing and notify appropriate people at an institution when disclosure is made, so the necessary reviews can take place to make sure there is no conflict," he says.

  • IRB module: MIT designed this module after holding several two-day conferences in which officials with other countries participated in the design.

The module has protocols logged in and assigned to committee schedules, putting them on the agenda, Dowdy says.

After the committee meets, it will record all voting and action the committee took, generate minutes and from those it automatically generates all letters to principal investigators, including approval letters and revision letters, he says.

"It keeps track of the historic record of all correspondence generated," Dowdy says. "It handles amendments, renewals, and sends out a reminder letter automatically of Don’t forget the protocol is going to expire next month, and you need to start the renewal process.’"

One new direction COEUS may take is into clinical trials management, but this will require funding outside of MIT, he notes.

Institutions interested in seeing COEUS improved may join a consortium in which they have input over new software design and changes to existing modules, Dowdy says.

These institutions will pay $25,000 to $50,000 for this privilege, but this seed money would be enough, possibly, to result in a clinical trials module, he says.

"Schools are becoming so heavily invested in COEUS that they want to participate at a higher level in the future," Dowdy says. "If you can only afford $500, that’s great; but for $25,000 — when I hold focus sessions — you get to voice your institution’s opinions, and that helps us understand how much more flexible the software has to be to be tailored to meet other schools’ needs."