Billing compliance and tracking regulatory data are good places to start.

"If you're in an environment where the research staff says, 'That's a billing issue,' then you've got a problem."

It's good timing to improve your research compliance program now that billions more dollars in federal funding from the health care reform and stimulus package continue to be pumped into the research economy. Such money brings increased regulatory scrutiny, and this means clinical trial (CT) sites will need to make certain they are following all rules.

Billing compliance and tracking regulatory data are good places to start.

Everyone at a CT site needs to be accountable for the billing compliance process, says Rachel Garman, LPN, CCRC, a research manager in oncology at Cancer Care Northwest of Spokane, WA.

"The big question as you struggle when dealing with a billing office is getting everyone to buy-in and work together in compliance," Garman says. "If you're in an environment where the research staff says, 'That's a billing issue,' then you've got a problem."

Regulatory compliance and tracking also require research staff buy-in and cooperation.

Often federally-funded studies have multiple investigators and institutions involved, and each study has its own story and its own number of different groups that have to track what's going on, says Pam Schwingl, PhD, a senior epidemiologist and National Institute of Environmental Health Sciences (NIEHS) support services project manager. Schwingl is with Social & Scientific Systems, an NIEHS contractor, in Durham, NC.

"That's why it's really important to create a database to track study information and streamline this effort," Schwingl says.

The NIEHS projects involve clinical epidemiology.

"We have studies that are done in clinics, but they're more observational studies," Schwingl says. "We prepare data and have some analytic programmers do data analysis for principal investigators."

The database keeps historical information about past IRB and regulatory submissions and their approvals, she says.

Deadline reminders

It helps study coordinators better manage their time by sending them reminders of deadlines.

"We determined the standard routine by polling study managers on how frequently they want reminders on particular due dates," says Elizabeth O'Connell, RN, BSN, senior study manager with Social & Scientific Systems.

"So we developed algorithm runs weekly, and every Thursday it sends out reminders on predetermined intervals, which could be six weeks, four weeks, or two weeks," she says.

When a manager submits a form, he or she has to put the submission date in the system.

"We have monthly reporting obligations, and that makes it easy for me to capture all of the information from one place to include in a written report," O'Connell says. "It gives us a tool to use to chase down the study managers and make sure they haven't just forgotten something."

If study managers don't document it, then it's not in the database, she adds.

Documentation also is integral to billing compliance.

Cancer Care Northwest has made this a consistent process by using various billing compliance tools, including a reimbursement billing distribution list, a billing guide, an audit form, and a reimbursement alert, Garman says.

"We designate one person to do all of the research billing," Garman says.

Also, once a month Garman meets with a billing specialist and verifies that each charge was billed correctly.

This was a huge undertaking initially.

"We decided to make sure we were very compliant and catch anything that's billed incorrectly," Garman says. "We wanted to make sure we were catching [mistakes] in a timely manner and identifying refunds as needed."

Regulatory mistakes also need to be caught and corrected as quickly as possible.

Usually researchers have been good at getting their documentation submitted on time, but it's important to have a back-up system for when a problem occurs, Schwingl says.

The NIEHS-funded tracking tool gives research coordinators reassurance that if they happen to forget about an upcoming regulatory deadline, they'll receive an automatic reminder.

Here are some of the tool's attributes:

• Database can handle multiple institutions: "We looked around and found some packages out there of databases that can do similar things," O'Connell says. "But we have to deal with multiple institutions, so having a database that has it all in one place has been extremely helpful."

For example, one study might have a site at a North Carolina university, and that institution's IRB will have its own database, but it won't be linked with Social & Scientific Systems, where much of the study work is being done.

"We need to document all that information here so we can access it more easily," O'Connell says.

"For us to be study managers and make sure all approvals are still active and that we have captured it in one place is something we didn't have before," O'Connell says. "To have the information centrally-located so that anybody can access it here within the company has been very helpful."

• Use system smart tags: "We put in smart tags within the system so if a study manager is looking at her particular protocol and needs to quickly look at an IRB meeting calendar, then there's a link," O'Connell says.

There also are links built into the project's Intranet that would navigate someone to the submission or approval documents that are needed.

"While this database captures all dates, it also links you to the actual history and forms," O'Connell says.

The smart tags make it easier for study managers to review their own protocols and find dates for all of the institutional deadlines during any given month, Schwingl notes.

"Each study manager can access reports by their own name so they can see their due dates, rather than have to sift through each project," O'Connell says.

• Limit access for changes and add visual cues: Everyone involved in the research project has access to the regulatory tracking tool and database, but only the programmer, O'Connell, and select others have the ability to make updates and edits within the database, O'Connell says.

"We color code things within the pages, so if something is blue, it means it's an upcoming deadline," she says. "If it's red, then it means it's past due."

This gives viewers a quick visual cue as to what is due and how soon.

• Encompass all regulatory issues: The tracking tool tracks all IRB information, material transfer agreements, investigators on project, Office of Management and Budget (OMB) reviews and submissions, and other details.

"It looks at the burden of participants for anything that has to do with the government," O'Connell says. "It stores the OMB registration number if you have to go through the OMB, and it tracks whether the project has gotten clinical exemptions from the OMB."

• Maintenance is minimal: "It's really easy to use, and in terms of maintenance it depends on how many protocols you've got," Schwingl says. "But in terms of updates, we have a research assistant-level person who handles it."

For instance, when NIEHS changed its algorithm for when packages were due, the research assistant went into the database and reprogrammed it with the new information.

[Editor's note: The NIEHS regulatory tracking database/tool was developed with federal funds, so it is available at no charge to anyone who would like to use it. For more information, contact Elizabeth O'Connell at oconnelle@niehs.nih.gov.]