The primary mission of David Welch, M.B.A. and Melissa Bazan, M.A., research compliance specialists in the Office of Regulatory Affairs and Compliance (ORAC), is to offer assistance to our principal investigators (PI) and research teams who can benefit from an operational review of study documents and protocols. ORAC recommendations often make the process of a compliance audit easier before an official audit occurs.
When asked about the services that ORAC provides, David replied, “I want investigators to know that getting a phone call from the research compliance office doesn’t automatically mean you’re in trouble. We offer a wealth of services, one of the most beneficial being our voluntary compliance audit.”
Investigators may request to have all study documents reviewed by David or Melissa which can typically be completed within two working days and does not require the PI to be present. A voluntary compliance audit saves time, greatly reduces stress, and prepares the research study team for successful audits. The infographic below provides an overview of the process.
Devjit Tripathy, M.D., is an endocrinologist and professor at UT Health San Antonio who has utilized these services, both to prepare for audits and facilitate an official Food and Drug Administration (FDA) on site visit. His primary research interests focus on understanding mechanisms that cause insulin resistance and conducting clinical trials validating T-2 diabetes treatments in patients with preexisting cardiovascular disease. As a PI of a major multisite study, Dr. Tripathy recieved a one-day notice that he was going to be audited by the FDA.
“Out of 150 other study sites, UT Health San Antonio was the second largest for patient recruitment. When you are one of the major recruiting sites, you’re typically going to be selected for an audit,” Dr. Tripathy shared, “and I found David and his team to be extremely helpful when the FDA visited. We have also used their team for two voluntary compliance audits and highly recommend other research teams to proactively use their services.”
When an FDA audit occurs, David and Melissa assist investigators and the clinical research coordinators with organizing all the study documents. They interface with the FDA auditor and guide the research team through the process by providing feedback, responding to questions about the protocol, patient protections and other compliance concerns. Dr. Tripathy and his research study team agreed that the service David and Melissa provided was valuable, educational and fun. Yes, fun!
“David and Melissa provide excellent customer service. Not only do they guide you through the process step by step, but they are approachable and knowledgeable,” said Andrea Hansis-Diarte, clinical research coordinator, “They provide an extra set of eyes and help needed for research teams to adhere to the highest regulatory rigor, and they do it with a smile!”
Editor's Note: The Office of Regulatory Affairs and Compliance is now known as the Institutional Office of Compliance and Privacy.