Spotlight on: The Regulatory Core

Since its inception, the North Carolina Clinical and Translational Sciences (NC TraCS) Institute has helped thousands of investigators conduct their research faster, cheaper and more efficiently. For its part, the NC TraCS Regulatory Core has worked to make regulatory and institutional compliance a seamless, coordinated process for researchers at UNC-Chapel Hill. Sam McLean, M.D., M.P.H., assistant professor of anesthesiology, has interacted with the Regulatory Core on 15 different occasions and feels their services have been invaluable to his research.

“One can read as many books on the conduct of clinical trials as one would like, but there are no specific instructions for the “nitty-gritty” of designing optimal data capture systems and SOPs [Standard Operating Procedures] for a specific study and setting,” said McLean.

“So at the end of the day, there is generally some degree of uncertainty regarding whether trial procedures and methods are “best practice” or optimal. And this is not a great feeling. The NC TraCS Quality Assurance Monitoring Review Program filled this critical gap, and did so in an extremely useful and professional manner. I know that my ability to function successfully and effectively as a clinical trialist has improved as a result of going through the NC TraCS Quality Assurance Monitoring Review Program.”

McLean turned to the Regulatory Core for help on three separate studies. The first, called the Burn Help Trial, was a pilot multi-site randomized control trial investigating the ability of the beta blocker propranolol to improve recovery in burn patients with specific genetic makeups. For this trial, the core gave extensive guidance on developing a safety monitoring plan; provided oversight through the TraCS Data and Safety Monitoring Board; lent guidance on numerous regulatory issues including expanding the study to include multiple sites and dealing with adverse events; and performed a Quality Assurance Review to educate the study team on how to collect and record data following Good Clinical Practices. In addition, NC TraCS provided Clinical and Translational Research Center (CTRC) nurses to give Research on Location support for study procedures.

The second study, the HELP PAIN Trial: Healing with Venlafaxine after Motor Vehicle Collision, is testing the effects of the antidepressant venlafaxine in relieving pain after car accidents. For this trial, NC TraCS is providing guidance on developing a Safety Monitoring Plan and is serving as the Data and Safety Monitoring Board. Finally, NC TraCS provided interim funding (TraC$ 50K) for a third study, the Women’s Health Study, a project investigating the feasibility and safety of performing longitudinal evaluations of sexual assault survivors who receive post-assault sexual assault nurse examiner care.

“Of the many types of institutional clinical research support that I have received over the years, both at UNC and at other academic centers, this has without a doubt been the most valuable,” continued McLean. “It is remarkable to me that in an era of such constrained resources, NC TraCS provides this service.”

The core’s impact has also been felt across campus. For example, the Regulatory Core hired a regulatory specialist to provide regulatory support for investigators submitting to the FDA. It also created a Scientific Review Sub-Committee to provide pre-IRB review of all clinical trials submitted to the four UNC biomedical IRBs with the goal of enhanced scientific expertise and improved scientific feedback to investigators. Finally, the core has raised awareness of the need for more campus-wide education and training to ensure investigator and study team compliance with regulations and improve the quality of clinical research.