Research sites can improve compliance by forming centralized CT operations
CT research has become more complex
Large research institutions can help clinical trial (CT) investigators and staff improve their study operations and regulatory compliance by providing clinical research staff services through a centralized office.
Best practice examples and current regulatory pressure have combined to make centralized CT offices a viable and attractive alternative to the traditional approach of each department having its own CT operation, experts say.
Centralized CT offices can oversee compliance and billing issues, as well as provide support services to investigators and research sites. Centralized CT offices might provide contracting services, a staffing pool, and assistance with the IRB submission.
"When you do things independently, you don't have the mentorship and training support that centralized offices provide," says Tammy Anderson, CCRC, CCRA, CRCP, director of the clinical trials office at the office of the vice president for health sciences, Virginia Commonwealth University in Richmond, VA. Anderson speaks about centralizing the IRB office at national conferences, including the MAGI Clinical Research Conference West, held Oct. 24-27, 2010, in San Francisco, CA.
"We can go into departments where they have new coordinators and provide them with mentors and training to make sure everything is set up properly," she explains. "We make sure new coordinators learn how to document properly and know which things are applicable to the conduct of research."
Without this training it's very difficult for a person coming in as a research coordinator to know which regulations, competencies, and training are necessary to their work.
"Protocols have become much more complex; the number of case report form pages has increased," Anderson says. "It's becoming more difficult for coordinators to do everything."
These issues contribute to start statistics: 80% of all investigators conduct only one clinical trial; 38% of physicians do not return to the clinical research enterprise within any given year, and 61% of current study coordinators held their position for less than three years, Anderson explains.
"This is a nationwide issue," she adds.
Research compliance is a bottom up process. It relies on front-line research coordinators and other staff adhering to regulatory requirements and best practice guidelines in their day-to-day jobs, says Kelly Willenberg, BSN, MBA, president of Synergism, LLC of Chesnee, SC. Synergism provides research compliance, including billing and program compliance services for clinical research sites.
However, research sites need help with compliance issues, which is why it's important to have a centralized research office or a designated billing or compliance manager to oversee compliance, education, and monitoring or audits, she adds.
Look for the deeper issues
Research investigators and staff often fear they have made mistakes in billing, but compliance issues can run deeper than this.
Often, research institutions have decentralized clinical research, conducted in departments that lack communication, training, and consistency, Willenberg says.
"They have undefined roles and responsibilities for staff," she adds. "They have all of these risks because they don't even know they have a risk."
Forming a centralized research office is one answer to this problem.
"Some sites are forming a centralized office because it's cost-effective," Willenberg says. "If you don't have a centralized office to handle clinical trials, billing compliance, and operations then you end up with a lack of consistency across an institution."
One model research institutions sometimes use involves having a centralized office for all research, except for studies conducted by the institution's cancer center. This occurs because cancer centers typically have been conducting research studies for decades. Often they have a clinical research process that is better evolved than other departments.
However, there is a big risk when the centralized office and the cancer center lack communication and consistency, Willenberg says.
For instance, pharmaceutical sponsors might be concerned when they see that research is being conducted differently at the same institution, she adds.
The solution would be for the institution to establish policies and procedures and standard operating procedures that are consistent from one department or research entity to the next. And the centralized office should have a clear avenue of communication with any remaining research offices.
If one department of a research institution has a good CT operation already, then it wouldn't make sense to fold that operation and make the department start over with a new centralized office, Willenberg acknowledges.
"You need to take the model you have in the cancer department and grow it across the institution," she says. "Then proper oversight will become a fluid process."
Also, when institutions form a central clinical research office they should look for ways to eliminate duplication. Perhaps a cancer department could keep its coordinator hiring and training process, but would be open to merging its billing process with the centralized office's billing.
Before Virginia Commonwealth University formed its centralized clinical research office, Anderson spoke with industry sponsors and others to determine what worked and what didn't.
"We set up several steering committees and groups to look at what clinical trials means from the different perspectives of billing, compliance, etc.," she says. "We looked at all different angles and aspects to determine where our gaps were and what were the needs."
The existing practice was for each university department to handle CT operations and budgeting separately. Each study coordinator hired would be in charge of study enrollment, IRB submissions, subject visits, documentation, and meeting with study monitors.
"If someone wanted to do clinical research, they'd hire someone to be a coordinator or nurse, and the only thing centralized in our university was the contracting aspect," Anderson says. "All contracts had to go through the office of central programs."
But studies sometimes ran into problems when new coordinators could not keep up with study enrollment, as well as all of the other daily tasks.
This created potential compliance issues since new research staff typically did not have the benefit of working with an experienced mentor. They also lacked the comprehensive type of training that would be available through a centralized research office, she adds.
"Prior to our creating the centralized office, it was very difficult for a person coming in as a research coordinator to know what the regulations and competencies and training were needed to work as a study coordinator," Anderson says.
Free up the coordinators
Virginia Commonwealth University's new centralized research office now offers investigators expertise in each area of CT operations. Investigators can contract to have a recruitment coordinator assist with their study's enrollment, and they can use one of the centralized office's regulatory specialists to assist with IRB submissions, case report form documentation, handling monitor visits, and other regulatory/documentation issues.
"This frees up their coordinators to screen patients as they're identified and to conduct visits," Anderson says. "They have time to see more patients."
The office, which opened in April 2010, now has five departments and nine investigators using its services.
Forming a centralized office is one good strategy for improving research compliance, particularly because it results in better consistency and communication, Willenberg says.
Research institutions with multiple CT offices can achieve better compliance, but only if they have everyone following the same process and budget template, she notes.
"When I go to a site, even if there are two or three different areas, I make sure they're all using the same budget-development templates and guides and have standardized pricing," she says. "This way you have better consistency with what you're doing, and compliance automatically increases because the flow of documentation is better."