Audit toolbag puts focus on improvement
New approaches can provide useful data for QA
Like many institutions, Dana-Farber/Harvard Cancer Center (DF/HCC) uses audits of studies to find areas in human subjects protection that need improvement and to educate researchers to address them.
As its auditing program has evolved over the past 30 years, DF/HCC has added a variety of auditing tools that can help accomplish this goal, even as the number of studies it oversees grows.
Most recently, the institution has added two new types of reviews by its quality assurance auditing team targeted audits, which look at a single issue across many studies, and risk assessment, in which auditors proactively look at studies with an eye toward the capacity of the investigator and study team to carry out research safely.
Dana-Farber's comprehensive auditing program recently was honored by the Health Improvement Institute with an Award for Excellence in Human Research Protection Best Practice. DF/HCC is a consortium of Boston-area institutions that includes Dana-Farber Cancer Center, Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Children's Hospital Boston and Brigham and Women's Hospital.
Alyssa K. Gateman, MPH, CCRP, deputy director of quality assurance for clinical trials for DF/HCC, says these newer tools have been added in recognition that the full-scope audits it has traditionally carried out can address only a small percentage of the consortium's growing research portfolio.
The quality assurance office has 5.5 full-time auditors and a manager, and a full-scope audit typically takes one of those auditors about five days.
"We have approximately 500 ongoing trials at a time, so there's no way with five individuals, that we'd be able to cover all of those trials," Gateman says. "So we were looking for ways that we'd be able to identify trends or compliance issues at a quicker speed."
Targeting compliance
In a targeted audit, auditors look at one specific area they believe might need attention, such as informed consent or adverse event reporting.
"We might choose 10 or 20 trials, and only request that teams and investigators submit that one document to us," Gateman says. "We can look across the board to see whether there are compliance concerns or if there are problems in one disease area."
DF/HCC began conducting targeted audits in 2011 and plans to undertake them least quarterly going forward. Gateman says they take a little longer to conduct than a traditional audit because of the involvement of so many investigators, but are time savers in the end.
"They do take a little bit more time as far as planning and organizing, but we're able to arrive at our conclusions quicker," she says. "By the time we'd done 20 full-scope audits and pulled the information together, it would be months down the road."
Assessing risks
The risk assessment piece of the auditing program also began in 2011. It focuses on the ability of the investigator and study team to carry out a study in compliance with all the relevant regulations. Auditors can look at issues such as the number of studies a particular investigator is involved in at one time, and the staffing levels for a study, to make sure there are enough qualified staff to support the study.
"It's really meant to be more of a gap analysis," Gateman says. "We can help them identify areas for improvement."
DF/HCC's first risk assessment was conducted at the request of the institution's pediatric oncology group for all of its accruing studies where the principal investigator was also the pediatric disease group leader. Auditors reviewed and ranked level of investigator oversight, staffing, the appropriateness of the facilities and completeness and accuracy of documentation.
So far, she says, the QA team has only done these assessments upon request by investigators. But she envisions expanding this service into administrator-initiated assessments.
Mock audits
In addition to these newer auditing methods, the QA team also conducts what it calls mock audits, to help research teams prepare for an outside review.
If an investigator is informed that a sponsor or regulatory agency is planning to conduct an audit of a study, the QA team is notified within 24 hours, Gateman says.
"We would actually work with the investigators, the clinical trials offices and the study teams," she says. "We'll go in and review the documents and try to answer any questions and also work with the teams on preparing them for what to expect from the external auditors."
She says the intensity of this review depends on how much time they have before the external audit and what information the QA team already possesses from previous in-house audits.
"If there's a trial where there are only a few subjects, we typically can do the whole trial load," she says. "If there's 100 subjects accrued and we only have a week, we pick and choose."
Gateman says a key to the success of this auditing program is the integration of the QA department with other functions, including education and the IRB office. Many of her auditors have IRB experience and so are very familiar with the regulatory requirements. The IRB director serves on the audit committee and the IRB can request audits if the board see issues arising in review.
When audits uncover a larger problem requiring new guidance or better education, the appropriate departments get involved. For example, Gateman says, the institution had struggled with the correct way to obtain consent from non-English speaking subjects.
"We had identified it as an issue a few years ago utilizing the short form, who was supposed sign what form, and following the regulations as far as documenting it," she says. "Our IRB office created a few guidance documents and had held several sessions on the proper use of the short form consent."
Gateman says that kind of integration and follow-up is an important part of a successful auditing program.
"Ensuring who's going to do what with the information [from audits] is very critical," she says. "You can take on targeted audits and find information, but unless there's an integrated process for how that information's going to be used, it really is non-beneficial."
Another important aspect is achieving buy-in from investigators, says Nareg Grigorian, data monitoring manager for the quality assurance team. This can be particularly challenging in a consortium such as DF/HCC.
"You have essentially autonomous institutions conducting research as a consortium and they've all agreed to participate within this structure," Grigorian says. "That would be very burdensome if there wasn't that level of cooperation. Everybody basically has to agree on the ground rules before they think about undertaking something like this."
Grigorian says the QA team also stresses to investigators that their purpose is to help them conduct trials, rather than simply policing them.
"It's more of another layer of protection and insulation for their benefit, and for their enhanced awareness of what the regulatory environment is that they will be held to," he says. "We try to create a more collaborative atmosphere, explaining why we're looking at what we're looking at, and that it's ultimately to their benefit."
Like many institutions, Dana-Farber/Harvard Cancer Center (DF/HCC) uses audits of studies to find areas in human subjects protection that need improvement and to educate researchers to address them.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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