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Q&A: Expert details her site's best practices
Clinical trial sites sometimes fail to look at the big picture when initiating a quality improvement process by not addressing billing compliance as thoroughly as needed.
In this Q&A interview, Suzanne M. Rivera, PhD, MSW, associate vice president of research services and special assistant to the president for strategic initiatives at the University of Texas Southwestern Medical Center in Dallas, provides her expert advice on how to ensure your quality improvement and compliance programs work well:
CTA: What are some of the most common issues that arise in clinical trial research compliance, and how can these be resolved?
Rivera: One thing we all recognize as an area of vulnerability that needs to be addressed very carefully is billing compliance in clinical trials. Often the offices responsible for approval of a study, negotiation of a contract, performance of a trial, and billing of charges all report up through different chains of command. Frequently, their data management systems don't share information back and forth. So what you end up with is a series of blind hand-offs, which can lead to billing of subjects or insurers for charges that really ought to be borne by study sponsors. Some institutions have recognized the problem and rather than bill inappropriately, they simply don't charge anyone for certain study-related expenses. This means they are absorbing trial costs out of fear. So this is one issue that can be resolved by establishing cross-departmental teams charged with establishing methods for communication that will ensure proper charging of trial expenses. The other important thing is to audit charges and correct mistakes. It's not enough to suspect you may have a problem; you need to investigate and verify that your systems of checks and balances are working properly.
Another thing many institutions are struggling with is how to deal with disclosure of financial interests and assessment of those interests to determine whether they may constitute a conflict. Much attention has been paid to this problem in the media and by government officials. I think we all are learning a great deal about the importance of preserving trust with the public. People expect universities and hospitals to keep a watchful eye on their research programs to prevent impropriety, and avoidance of financial conflicts of interest is a really hot topic right now.
CTA: Would you please tell us more about your data management system investment and how this has helped with compliance and improving quality?
Rivera: We are implementing new data management systems for IRB review and study oversight, for clinical trials management, and for enterprise-wide financial and personnel management. These efforts are being coordinated closely to ensure that data flow in all the directions necessary to prevent problems on the front end and to identify issues requiring resolution. We have accomplished this coordination through a research administration advisory council that has representatives from the information technology department, business affairs, institutional compliance, research administration, post-award accounting, and all the regulatory committees.
The council also has faculty representatives who help us understand how things really work in the trenches. Without a way of collaborating across institutional lines, these software implementations merely would have re-inscribed the same old organizational silos. Instead, we are taking this opportunity to re-engineer the way research administration gets done.
CTA: How has your institution changed its compliance focus in recent years due to industry and regulatory trends?
Rivera: We have invested significantly in three areas: education of investigators and research personnel, dedicated staff to perform post-approval monitoring, and data management systems to make reporting, trend-analysis, and sharing of information across departments much easier. Investing in education is an obvious way to improve. The vast majority of researchers want to conduct trials properly, but there are so many rules, and the landscape seems to change frequently. If we can help them understand their obligations on the front end, we'll have fewer problems showing up during the post-approval monitoring on the back end.
For monitoring, we do two types: not-for-cause program improvement reviews, which are done to help. And for-cause audits, which are done to investigate a concern or allegation. In either case, we work very hard to convey that we are there to support the research enterprise.
CTA: What are your best practices? For instance, how do you prevent compliance issues, monitor for problems, and fix/resolve issues that arise?
Rivera: The best method of prevention is education. That includes formal training classes, Web-based tutorials, informative Web sites, use of list servs, and messaging through various other communication media. We think our not-for-cause program improvement reviews also are a form of education.
When a problem is discovered, we try to facilitate resolution and not to come down like a hammer. This is very important for establishing trust. In cases of minor paperwork infractions, we assist the investigator to get everything in order quickly. When done well, this will establish that the staff add value and are here as a resource, not a police force.
When serious or continuing problems are identified, we follow a structured standard operating procedure for involving the institutional review board and, when warranted, making a report to federal authorities. Even in those cases, it is almost always possible to develop a corrective action plan that will ameliorate the infraction and prevent something of a similar nature from happening again. This could involve training, mentoring, requiring frequent reporting to the IRB, or any number of other steps to ensure we are meeting our mandate to protect the rights and welfare of subjects while conducting first-rate science.