Compliance-related services are being reorganized to better help researchers navigate regulations and meet requirements.
As Carolina’s research enterprise grows, the Office of the Vice Chancellor for Research (OVCR) continues to evaluate how the administration can effectively facilitate the research process. As part of this evaluation, compliance efforts are being updated to better meet the needs of investigators.
UNC Research spoke to Assistant Vice Chancellor for Research Compliance Quinton Johnson and newly appointed Clinical Research Compliance Director Valorie Buchholz about their strategy for streamlining the program.
Compliance imperative
“Our goal is to support our faculty and staff so they can conduct the research that’s important to them and the citizens of North Carolina,” Johnson says.
Carolina’s research enterprise receives a significant amount of federal funding, which requires strict adherence to various regulations and policies, especially when it comes to the development of new drugs and devices. This comes under the purview of the FDA, whose regulatory framework is extremely complex.
“The FDA-regulated space is high-risk,” Quinton says. “These project requirements are unique because you have to get it right from the beginning. You need to collect good data, store it appropriately, and document it properly. It’s a wholistic lifecycle of developing intellectual property.”
To support the numerous FDA-regulated projects at UNC-Chapel Hill, OVCR’s compliance team is undergoing some changes.
Organizational changes
Moving forward, Johnson will oversee three compliance-related offices within OVCR — Export Control, Science and Security, and the newly created Clinical Research Compliance, which will be taking over responsibilities from the Office of Clinical Trials.
A new position is being created within the Clinical Research Compliance Office (CRCO), which Buchholz leads, to manage multiple areas including compliance related to GXP — a catchall for Good Manufacturing Practice, Good Clinical Practice, and Good Laboratory Practice. Additionally, Clinical Trials Quality Assurance and ct.gov will also fall under CRCO.
“We want to change the structure in a way that makes true offices and positions out of what was disparate subject matter experts before,” Buchholz says.
OVCR’s compliance team will also help support the ONE UNC Clinical Research initiative as it grows, bringing together personnel from NC TraCS and the School of Medicine’s Clinical Research Support Office to develop a facilitative structure for investigators and their teams.
While CRCO establishes the scalable infrastructure needed to navigate the evolving research and regulatory environment, Carolina will partner with Advarra to ensure there is no gap in services. These changes will help compliance programs achieve the goal of providing internal support to investigators at any point in the research process.
Looking forward
Compliance leaders are working to bring together groups across campus to provide the research community with resources to help understand and adhere to best practices.
“We’re looking at areas where we may have service gaps and figuring out how to mitigate those,” Buchholz says. “We’re meeting with leadership, faculty, and staff to get their perspective of where they might see compliance needs.”
While Buchholz and Johnson say centralization is a goal, some of their key partners will always be faculty and staff associated with study teams across the University. By pooling resources, providing guardrails, and having easily accessible subject matter experts, clinical research teams can better fulfill compliance responsibilities for their projects.