An online guidebook detailing the clinical research process and available support resources at Penn State is now available for faculty and staff at all University campuses.
Based on a guidebook released last year specifically for Penn State College of Medicine, it is a collaborative effort of Penn State Clinical and Translational Science Institute, Penn State Social Science Research Institute and the Office of the Senior Vice President for Research.
“The amount of clinical research happening outside the College of Medicine is growing quickly,” said Justin Snyder, quality management coordinator, Office for Research Protections. ”The Office of Research Protections has been working with the Clinical and Translational Science Institute to make sure that investigators have the support for clinical trials they need. The guidebook is an important part of that.”
With the broadened definition of clinical trials from the National Institutes of Health, the number of investigators who need this support is increasing.
The guidebook includes sections on several aspects of the research process, including resources and training, study development and feasibility, financial consideration, compliance and protected health information. It guides an investigator through necessary first steps, such as training resources and trial development, obtaining required approvals and maintenance of a trial through closure stages. Links provide direct access to additional information for each topic.
“Some investigators conducting clinical research at University Park and the Commonwealth Campuses have a background in basic science so that they may be unfamiliar with the special rules, regulations and best practices for clinical research,” Snyder said. “The guidebook acts as a digital concierge for anyone at Penn State conducting clinical research, but especially those outside the College of Medicine.”
The guidebook is an example of collaboration within the Clinical and Translational Science Award program. University of California Davis Clinical and Translational Science Institute shared its guidebook, including editable files, with Penn State to use as a foundation. Dee Bagshaw, Penn State Clinical and Translational Science Institute program manager, worked with Snyder to collect information and assemble the guidebook for University Park and the Commonwealth Campuses.
“The mission of Penn State Clinical and Translational Science Institute is to accelerate discoveries to benefit human health, including by helping our researchers move their research more efficiently and effectively out of their laboratories and into use by the people who need it,” said Susan McHale, institute associate director and director of Penn State Social Science Research Institute. “The guidebook at the College of Medicine has been well received as a valuable resource. We believe that researchers at University Park and our Commonwealth Campuses will benefit as well from this comprehensive resource.”
The guidebook is hosted on the Social Science Research Institute website and will be regularly updated. It is part of Penn State Clinical and Translational Science Institute’s initiatives around clinical research, through its Hub Capacity Core, and workforce development.
The guidebook for University Park and the Commonwealth Campuses is available here, and the College of Medicine guidebook is available here.
To request a consultation with Penn State Clinical and Translational Science Institute, complete a service request form.