Avoid audit trouble by improving processes 

Strict accounting system is needed

Investigators sometimes will rely on the old and less detailed way of handling expenses during a clinical trial, so it might be up to the clinical trials staff to make certain everything is done correctly and documented to avoid audit red marks.

Bruce Steinert, PhD, CCRA, director of the clinical trials administration at Children’s Mercy Hospital in Kansas City, MO, offers these suggestions for avoiding process snafus that might result in an unfavorable audit:

  • Accurately document all time spent on federal grant studies. Investigators often are juggling trials sponsored by industry and those sponsored by the federal government, but requirements for keeping track of costs are very different between the two, Steinert notes.

"We deal with commercial sponsors where there’s no effort reporting," he says. "They don’t care whether you spend one hour or 20 hours because you are reimbursed whatever the agreement says."

However, on the federal grant side, an investigator can only receive up to 100% of the grant, but every penny of time and effort must be documented, Steinert adds.

"Part of your 100% research effort on the NIH side is going to be on the NIH project; but if you spend 25% of your time on this project and 75% of your time doing other things, then all of this has to be accounted for," he explains.

"So if you have an FDA-, industry-sponsored study where you see one patient every few months, how does that get reported back on the NIH grant side?" Steinert says. "And there’s another wrinkle: The FDA-type, industry contracts have nondisclosure clauses that prohibit us from acknowledging the existence of the trial, so you are having the conflict of being required to report something you can’t report."

The way to circumvent this problem is by naming the industry-sponsored trial in general terms such as saying it’s a diabetes study and then naming the amount of time that was spent on it, he notes.

The real problem is that many physicians have no idea how much time they’re putting into a particular project because many research institutions do not have a tracking mechanism for breaking down their time between projects, Steinert says.

"Nothing says that on this day you spent five hours working on this project, which went into this account," he says.

So investigators will swipe in a time sheet when they arrive in the morning, but they don’t do any other time documentation the rest of the day, Steinert notes.

"We send out forms to them, and they certify how much they did on such and such a thing, but it’s only traceable back to their word against anybody else’s word," he says.

Steinert once worked with an administrator who used a system where investigators could allocate sections of time to different cost centers on a paper form. Then at the end of the pay period, these forms were scanned into the computer program where administrators easily could see who had worked on which project and for how long.

However, this novel approach didn’t last long, he says. "People didn’t like coloring in the dots when they could just swipe a card and be done with it."

So the old system prevailed in which investigators often put in the same amount of time for each project each month, Steinert notes.

"It looks funny to auditors, but all we can do is say that’s how they reported it," he says.

Although the NIH hasn’t made a major issue of accurate effort reporting thus far, every time an NIH official speaks on the topic, the message is that clinical trials offices need to keep track of time and effort, and if an organization is having trouble, that’s an area that will be examined, Steinert says.

  • Consider regulatory rules if electronic record keeping is used. "The NIH doesn’t have too stringent a requirement on electronic records," Steinert says. "Whatever works for your hospital system, they’re willing to accept, and most do a fairly good job."

However, on the FDA side, clinical trials offices have to contend with CFR 21, Part 11, regarding electronic records and electronic signatures, he notes.

"And at the present time the FDA has pulled their guidance on how to comply with that," Steinert says. "The regulation still is there, but they don’t tell you how to enforce it."

And the regulation itself is somewhat intimidating with terms such as "adequate validation and certification," he says.

"I’m logged into a discussion group that does nothing but Part 11 compliance, and every day there are e-mails about people discussing picky things like page formatting and anticipating what the FDA might want to see at some point," Steinert says. "Our general patient record doesn’t have to be Part 11-compliant because that’s how hospital general records are set up."

But they do have to meet current needs for Medicare, Medicaid, and industry standards, he says.

"So when the research comes along, it adds another layer of complexity," Steinert adds.

Children’s Mercy Hospital has one study subject to Part 11 compliance, and the sponsor has provided the computer, which is totally separate from the rest of the hospital’s computer system, he says.

"At the end of the study, the computer goes back to the sponsor," Steinert says. "I’d hate to think that for every study, we’d have to have a [new] computer on site."

On the positive side, Part 11 compliance has been such a problem for the FDA that the agency pulled its guidance and came out with the critical path initiative in which it was intended to adopt more electronic records standards, he reports.

"The original Part 11 regulation was to make electronic records function like paper records," Steinert explains. "The recording data never posed a problem; the problem was tracking changes."

For instance, on a paper form, a person will initial each change so the FDA can come back and see who made the change and at which date and for what reason, he says.

Hospital records, however, don’t provide that level of detail. Once a change is made, the old notation is gone, Steinert adds.

To meet Part 11 compliance, there has to be a way to verify that a person had access to the record, changed an item on this date, and this becomes very complex, he says.

  • Keep up with hazardous shipping training requirements. "In the federal government’s regulations, dry ice is considered a hazardous material, and there are hundreds of these shipments on dry ice going across country," he says.

The regulations governing these shipments have training requirements with stipulations that the training be documented and repeated every two years, Steinert notes.

"We talk to people on the loading dock and say, We’d like to participate in your training program, and we get a deer-in-the-headlights look,’" he says.

So the solution might be to buy a computer training course and modify it for research coordinators and others who might handle the occasional dry ice or other hazardous shipping material, Steinert says.

Everyone who packs or signs the shipping form needs to take this training, he adds.

"Research coordinators usually are the ones doing this, and it’s been a requirement only for the last four or five years," Steinert says. "The regulations do allow for the training to be job-specific, so they don’t have to study regulations about shipping on freight cars."