Citing the Institute

"The project described was supported by the National Center for Advancing Translational Sciences through Grant UM1TR006339. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH."

"The project described was supported by the National Center for Advancing Translational Sciences through Grant UM1TR006339 and Grant K12TR006368. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH."

"The project described was supported by the National Center for Advancing Translational Sciences, Grant K12TR006368 and Grant UM1TR006339. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH."

"The project described was supported by the National Center for Advancing Translational Sciences through Grant UM1TR006339 and Grant K12TR006368. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH."

"Study data were collected and managed using REDCap electronic data capture tools hosted at Penn State Health Milton S. Hershey Medical Center and Penn State College of Medicine.¹ REDCap (Research Electronic Data Capture) is a secure, web-based application designed to support data capture for research studies, providing: (1) an intuitive interface for validated data entry; (2) audit trails for tracking data manipulation and export procedures; and (3) automated export procedures for seamless data downloads to common statistical packages procedures for importing data from external sources."

¹ Paul A. Harris, Robert Taylor, Robert Thielke, Jonathon Payne, Nathaniel Gonzalez, Jose G. Conde, "Research electronic data capture (REDCap) – A metadata-driven methodology and workflow process for providing translational research informatics support," J Biomed Inform. 2009 Apr; 42(2):377-81.

"Recruitment for the study [included/was done via] ResearchMatch, a national health volunteer registry that was created by several academic institutions and supported by the U.S. National Institutes of Health as part of the Clinical Translational Science Award (CTSA) program. ResearchMatch has a large population of volunteers who have consented to be contacted by researchers about health studies for which they may be eligible. Review and approval for this study and all procedures was obtained from [IRB name]."

If a TriNetX platform with browser-based real-time analytical features was used: “….We used TriNetX, a global federated health research network providing access to electronic medical records (diagnoses, procedures, medications, laboratory values, genomic information) from large Healthcare Organizations. The TriNetX platform only uses aggregated counts and statistical summaries of de-identified information. No Protected Health Information (PHI) or Personal Data is made available to the users of the platform…” If a dataset, downloaded from TriNetX, was used: “….TriNetX, a global health research network provided a de-identified dataset of electronic medical records (diagnoses, procedures, medications, laboratory values, genomic information) from xy patients with [cohort definition]. The data is de-identified based on standard defined in Section §164.514(a) of the HIPAA Privacy Rule. The process by which Data Sets are de-identified is attested to through a formal determination by a qualified expert as defined in Section §164.514(b)(1) of the HIPAA Privacy Rule. Protected Health Information (PHI) or Personal Data is made available to the users of the platform…” This general description should be followed by a description of the actual methods used including the date of the data download or when the analytics were performed.

Available on both the University Park and Hershey campuses, the Clinical Research Centers provide dedicated infrastructure and expertise to support high-quality, safe, and efficient clinical research. The centers serve as a home for clinical research, offering expert nursing and clinical support, specialized equipment and facilities, and a medical director on a fee-for-service basis. Dedicated CRCs at both campuses are central to supporting the conduct of clinical studies by providing trained staff, standardized processes, and the specialized space and equipment needed to safely collect high-quality research data.

Both centers include reception and waiting areas, outpatient testing rooms, nursing stations, specimen processing areas, and offices for clinical staff and administrators. The Hershey CRC includes 6,800 square feet of clinical research space and includes five patient examination rooms, an interview/consultation room, a dual-energy X-ray absorptiometry (DXA) scanner, two procedure rooms, three infusion/sleep rooms, and an observational suite with dedicated ventilation to accommodate smoking and similar studies. The center also has ultrasound capabilities. The University Park CRC is housed in a 14,000-square-foot custom-designed, three-story facility within the Noll Physiologic Research Center. The facility, which was co-funded with private support (Elmore Research Wing), is designed to be adaptable to the needs of individual research protocols. It includes six double rooms that can be configured for a variety of procedures, two invasive procedure rooms, an examination room, and extensive office space. Specialized equipment includes a dual DXA scanners, cardiac and vascular ultrasound, exercise equipment and a metabolic cart, refrigerated centrifuges, an ultrasound machine, as well as equipment for medical evaluation and treatment. A Bio-nutrition Unit has been essential to the campus’s researchers; it employs a certified dietary manager who plans and provides metabolic diets for studies. The unit includes a dining area with seating for about 20 volunteers, a fully equipped metabolic kitchen with food preparation areas, a walk-in refrigerator/freezer, and food storage areas. A multidisciplinary team of research nurses, medical assistants, nutritionists, and dietitians supports diet analysis, development of specialized formula meals and complete diets, and the conduct of controlled-feeding studies.

Across both campuses, the CRC’s provide access to experienced research nurses and clinical staff who are trained in Good Clinical Practice and in the processes and procedures required to support clinical trials. Together, the CRC’s provide the College of Health and Human Development and the College of Medicine with a coordinated infrastructure for conducting patient-oriented research, supporting participant safety, protocol fidelity, and the collection of high-quality clinical research data.

Penn State Clinical and Translational Science Institute provides the tools, resources and training to help the Penn State community move its health research more efficiently and effectively out of science laboratories and into use by the people and communities who need it. National Center for Advancing Translational Sciences and its Clinical and Translational Science Award (Grant: UM1TR006339) fund the institute. Penn State is one of three National Institutes of Health Clinical and Translational Science Award Network members in Pennsylvania and focuses on the health needs of the rural communities that surround Penn State and its academic health system, Penn State Health. Our CTSI is organized around investigator-centered services and programs spanning research support, workforce development, community connections, data science, and implementation science. A primary goal of the CTSI is to strengthen our Rural Clinical Research Network and we have assembled a statewide clinical network that includes Penn State Health, Allegheny Health Network and Highmark Health, Primary Health Network, Geisinger Health System, and the Pennsylvania Association of Community Health Centers. Together, this expansive network comprises 32 hospitals and over 1,100 clinics and health centers, caring for over 5 million patients—nearly 40% of the state's population. This infrastructure is designed to help investigators move research forward from study design and startup through implementation, dissemination, and impact. The institute leverages resources from numerous colleges and departments across two Penn State locations – Hershey and University Park. The institute is a member of a consortium of institutions that is using the NIH funding to increase its infrastructure to support translational research. Penn State’s commitment to the institute includes a 14,000-square-foot Clinical Research Center at University Park, a 6,800-square-foot Clinical Research Center at Penn State Health Milton S. Hershey Medical Center in Hershey, a 1,900-square-foot office suite at Penn State College of Medicine and offices at the University Park campus that house as the administrative core. Through its Community and Stakeholder Engagement Research module, the institute offers several opportunities for community input in research studies and collaboration with Penn State researchers. It builds strategic partnerships with community organizations to align Penn State research with the issues that matter most to communities. Through a growing data science program, Penn State researchers have access to electronic health record data and tools to conduct cohort discovery and study feasibility. It continually looks for new ways to manage the increasing amount of available data in ways that benefit Penn State researchers. Through its Clinical and Translational Science Award, Penn State is a member of the Trial Innovation Network, which provides study investigators with a broad range of services and consultations to optimize multi-site clinical trials and studies. These services and consultations are designed to help investigators develop proposals into protocols, optimize study operations, and enhance recruitment and enrollment. The Trial Innovation Network is a rapidly developing and evolving collaborative initiative that leverages the expertise, skills, and knowledge of the entire CTSA Consortium. Penn State investigators can utilize the Trial Innovation Network by working with the institute’s Trial Innovation Network Hub Liaison Team. Established in 2007, with multiple renewals, the institute received a $28 million NIH award in 2026 to support its mission for an additional seven years.