The National Institutes of Health (NIH) has broadened the definition of clinical trials and the need for support and training of investigators is markedly increasing. Penn State has released an online guidebook detailing the clinical research process and available support resources and is now available at all University campuses. The guidebook represents the work product of 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 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 offers the investigator a roadmap of necessary first steps, such as training resources and trial development, obtaining required approvals and maintenance of a trial through closure stages. They offer links with direct access to additional information for each topic.
Expanding Research Training to Clinical Trials
As Justin Snyder quality management coordinator, Office for Research Protections noted “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 practice for clinical research.” Snyder continued “The guidebook acts as a digital concierge for anyone at Penn State conducting clinical research, but especially those outside the College of Medicine.”
Result of Sharing and Collaboration—Knowledge is Social
The Penn State 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.
Ramping up Clinical Investigational Site Training
From the U.S. academic medical centers to specialized clinical trials networks to privately-held physician network the need for clinical investigator training and education has never been greater. From updating investigators on the latest ICH E6 guidelines to the rapid advancements of precision science to the explosion of translational research programs if research is going to keep up with the advancement of scientific opportunity training and education will be critical moving forward.