Citing the Institute

“The project described was supported by the National Center for Advancing Translational Sciences, National Institutes of Health, through Grant UL1 TR002014. 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, National Institutes of Health, through Grant UL1 TR002014 and Grant UL1 TR00045. 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 KL2 TR002015 and Grant UL1 TR002014. 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 TL1 TR002016 and Grant UL1 TR002014. 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 U54 TR002014-05A1. 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 serve as a home for clinical research. On a fee for service basis (with discounted rates for NIH-funded studies and trainees), the centers provide expert nursing care, equipment and state of the art facilities, physician oversight and consultations regarding study protocols. Having dedicated Clinical Research Centers at both campuses to conduct clinical research is central to promoting patient safety as well as providing high-quality equipment and trained staff to obtain data. Each site includes a reception and waiting area, outpatient testing rooms, a secure file room, a nursing station, a specimen processing room, and offices for clinical staff and administrators.

The Hershey site includes 6,800 square feet of clinical research space, including five patient exam rooms, an interview/consult room, a dual x-ray absorptiometry (DXA) scanner, two procedure rooms, three infusion/sleep rooms, an observational suite with dedicated ventilation to accommodate smoking and similar studies, and an exercise facility. The center has extensive ultrasound capabilities with multiple portable devices for cardiovascular, abdominal, and pelvic ultrasound exams.

The University Park site is housed in a 14,000 square foot custom-designed, three-story building at the Noll Physiologic Research Center that was co-funded with private support (Elmore Research Wing) and can be adapted to the needs of individual protocols. The facility includes six double rooms that can be configured for various types of procedures, two invasive procedure rooms, an examination room, and extensive office space. Equipment includes two dual DXA scanners, cardiac and vascular ultrasound, exercise
equipment and 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, walk-in refrigerator/freezer and food storage areas. In addition to a skilled staff of research nurses, medical assistants and nutritionists, a dietitian and metabolic kitchen are on-site to handle diet analysis, development of special formula meals and complete diets, and to provide facilities for controlled feeding studies.

Through these centers, the College of Health and Human Development and the College of Medicine ensure that research trained ACLS nurses are available for clinical studies. These individuals are trained in Good Clinical Practice and the processes and procedures required for clinical trials.

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: UL1 TR002014) 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.

Through its cores, the institute provides research tools, advanced biostatistical expertise, funding programs for exploration of unique ideas and a dedicated team for partnering with the community more effectively in research. The institute trains the next generation of translational and clinical scientists with several opportunities for Penn State’s medical and graduate students, including a dual degree in clinical and translational science. A scholar program invests in early-career faculty by providing dedicated research time while promoting collaboration and presenting translational research basics.

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-Engaged Research Core, 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 informatics 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 $19 million NIH award in 2021 to support its mission for an additional five years.