Penn State College of Medicine’s Clinical Trials Office enhances, fosters and promotes organized, high-quality clinical research. By promoting clinical research, the Clinical Trials Office helps Penn State Health and Penn State College of Medicine meet the mission goals of excellence in patient care, education, research and community service.
Each year, the College of Medicine approves more than 400 new clinical research studies, with investigators conducting research in 1,500 ongoing studies. Many of these studies utilize the services of the Clinical Trials Office. Since its establishment in the 1990s, the office has grown to offer services such as include protocol and budget feasibility assessment, budget preparation and negotiation, regulatory and IRB submission and oversight, study coordinator services and clinical trial placement.
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The clinical research guidebook was developed to provide a one-stop guide for faculty and staff members engaged in clinical research at Penn State College of Medicine/Penn State Health Milton S. Hershey Medical Center.
It has been adapted from the materials created and released by The Clinical Trials Resource Group at the University of California-Davis CTSC.
The Study Tracking and Analysis for Research (STAR) system is a comprehensive online tool designed to facilitate the submission, approval and management of select clinical research studies within Penn State Health Milton S. Hershey Medical Center and Penn State College of Medicine.
STAR is part of Penn State’s Centralized Application Tracking System (CATS) and is integrated with CATS IRB.
This information is extracted from CATS IRB for studies that have submitted a modification requesting the use of StudyFinder for recruitment.
Protocol and Budget Support
The Clinical Trials Office determines protocol feasibility, analyzes the research budget and may submit regulatory documents.
Prior to protocol and budget review by the Clinical Trials Office, a Confidentiality Disclosure Agreement (CDA), also known as a Non-Disclosure Agreement (NDA), must be in place.
The Clinical Trials Office provides payer coverage analysis, which is a review of research-related documents to determine the Medicare billing status of both the study and the items/services provided to research subjects as part of a research study.
The coordinator worksheet requires study coordinators to complete only a personnel costs page when submitting a study in STAR.
Study teams should upload the coordinator worksheet to STAR before attending the budget/feasibility meeting. The worksheet can be uploaded using the “Upload Budget Documents” activity on the Budget Workspace (under the Internal Budget section). Once uploaded as COORDINATOR_WORKSHEET, the document will reside in the Budget Workspace under the Documents tab.
Download the Coordinator Worksheet from Box
(Penn State Access ID login required)
The following links provide a breakdown of startup budget considerations and guidance and resources for ongoing financial study management for clinical research.
- Clinical research summary sheet
- Patient care cost guidelines
- Office of Sponsored Programs fringe and F&A rate agreements
- Penn State Policy RA30 (Facilities and Administrative F&A Costs)
- Penn State Policy RA90 Finalization & Closure (formerly RAG 05 and RAG 08)
- Clinical research monthly procedure reports memo
- Guidelines for financial management of industry-sponsored clinical trials
- Hershey Outpatient Surgery Center (HOSC) Standard Operating Procedure for the conduct of clinical research
- Sponsor invoice template (available in Box; Penn State Access ID login required)
In order to accurately track subject stipends and reimbursements, investigators may reference the following information or refer to the IRB information sheet “Compensation for Research Participants” found in CATS IRB.
For processing of the research study participant payment form, investigators should work with their post-award clinical trials financial contact in order to obtain access to the network folder dropbox. An IT Account Request Form is required to obtain access. A scanned copy of the payment form is then dropped in the network folder and processed. The payment form should be filled out completely in order to prevent delay in processing. Note that a Social Security number is not needed if reimbursement is for travel only.
- Payments to Human Participants in Research (University Guideline RPG03)
- Gift card procedure
- Sample gift card tracking log (available in Box; Penn State Access ID login required)
- Sample gift card verification form (available in Box; Penn State Access ID login required)
- Research study participant payment form (availabe in Box; Penn State Access ID login required) – note that no Social Security number is needed on this form if payment is for travel only, and forms with SSNs included CANNOT be transmitted electronically
- University non-employee information form (to be completed only if subject is not a U.S. citizen)
For questions, contact the Clinical Trials Office.