CTSA Program hubs collaborate to help researchers navigate complex regulatory environment

Three North Carolina Clinical and Translational Science Awards (CTSA) Program hubs have collaborated to create a platform for sharing regulatory expertise and best practices. The Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD) Program provides researchers with regulatory guidance, education, and consultative support, to ultimately help them move promising products and novel discoveries to clinical trials.

ReGARDD, which is coordinated by the hubs at Duke University, the Wake Forest School of Medicine, and the University of North Carolina at Chapel Hill (UNC-Chapel Hill) with partner RTI International, officially launched in 2015 and has been developing since. The program builds upon the existing services and knowledge of the North Carolina CTSA Program Regulatory Groups and the Research Triangle Park (RTP).

Regulatory science, or the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of Food and Drug Administration (FDA)-regulated products, has recently become an area of intense interest in translational science. In fact, the National Institutes of Health (NIH) and the FDA have launched a number of programs to enhance the translation of research into products that benefit patients and improve the success rate of developing safe and effective drugs and devices.

However, with ever-changing regulatory requirements, there’s a need for resources that improve and guide decision-making, ensuring a successful pathway from discovery to clinical implementation.

“As medical technology progresses and the research landscape evolves, there’s a growing demand for updated regulatory guidance for things like the use of mobile medical applications, which often require FDA approval,” said Marie Rape, associate director of Regulatory Service at NC TraCS Institute, UNC-Chapel Hill’s CTSA Program hub. “We want to provide researchers with a roadmap that removes the guess-work and helps move their research forward.”

The ReGARDD Program’s website features resources such as best practices for preparing Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications, FDA protocol and submission templates, decision trees, and FAQs, among other tools to support investigators’ regulatory needs. Many of the available resources also feature accompanying videos to supplement written content and better explain commonly asked questions.

Rape noted that while much of this information can be found on the FDA site, the ReGARDD platform houses the most relevant information to academic and translational researchers all in one place, and will hopefully foster collaboration among CTSA Program hubs.

“In addition to helping ensure high-quality and compliant research, we hope this platform will harmonize efforts and reduce duplication through the sharing of resources across the CTSA Program consortium,” said Rape.

Learn more about the ReGARDD Program by visiting regardd.org. Related questions can be directed to Michelle Maclay, director of community and partner relations, NC TraCS Institute.


The program described in this article is funded in part by the Clinical and Translational Science Awards (CTSA) Program from the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH), to each of the member institutions:

  • University of North Carolina at Chapel Hill and RTI International (grant UL1TR001111)
  • Duke University (grant UL1TR001117)
  • Wake Forest University (grant UL1TR001420)

The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

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