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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This searchable directory provides a quick reference to the many templates and forms described elsewhere on this page.
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.
This information is extracted from CATS IRB for studies that have submitted a modification requesting the use of Studyfinder for recruitment.
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.
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.
- IT Account Request Form (internal access only; Penn State Health ePass login required)
- University Guideline RPG03 Payments to Human Participants in Research
- Gift card procedure
- Gift card tracking log (available in Box; Penn State Access ID login required)
- 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.
A set of Standard Operating Procedures for Clinical Research describes the preparation and maintenance that the research team follows to ensure compliance with all FDA regulations and guidelines, and the policies and procedures of the College of Medicine and Penn State for all clinical trials conducted at Penn State.
These procedures are currently under revision and will be distributed when that process is complete. With specific questions in the interim, contact the Clinical Trials Office.
For proposals that do not meet the criteria to be submitted to STAR, investigators must submit an Internal Approval Form, or IAF, to the Office of Research Affairs. (This is generally used for industry-sponsored clinical trials.)
Device Trial Information
Note: The Medicare Administrative Contractor (MAC) for Penn State Health/Penn State College of Medicine is Novitas Solutions Inc. As of July 1, 2013, the jurisdiction is designated as JL instead of J12. Currently, Novitas is requiring faxes (see template in Box; Penn State Access ID login required) rather than mail communications.
The Centers for Medicare & Medicaid Services (CMS) have established regulations for coverage of device trials. These rules are found in the Code of Federal Regulations 42CFR 405.201 – 405.215 and 411.215 and 411.406. The study qualifies for Medicare coverage if the device trial meets the criteria in the regulations. In turn, this means routine costs during the qualifying device trial are covered. Even when a device is provided without charge, the MAC must still approve the study for routine costs to be billable.
- For IDEs approved by the FDA on or after Jan. 1, 2015, it is the sponsor’s responsibility to submit to national CMS for “Approval” – not the individual research site providers. Novitas requests certain information be sent to them before institutional claims are submitted. This “Notification” will allow Novitas to add information to their claims payment system to ensure proper processing of claims occurs.
- Penn State Health will fax the “Notification” (see template in Box; Penn State Access ID login required) to Novitas Solutions Inc., including the following:
- CMS Approval Letter including the six-digit IDE Study and eight-digit National Clinical Trial (NCT) numbers
- Name(s) of hospital/facility and their Provider Transaction Access Number(s) (PTAN)
More information can be found on the Novitas Solutions website.
Investigational Device Exemption (IDE)
The FDA recognizes three regulatory classes of medical devices. For purposes of assisting CMS in determining Medicare coverage, the FDA will place all approved IDEs in one of two categories: Category A or Category B.
Investigational Device Categories: Medicare Coverage Principles
For IDEs approved by the FDA on or after Jan. 1, 2015, it will be the sponsor’s responsibility to submit to national CMS and provide Penn State Health with documentation. Penn State Health/Penn State College of Medicine will contact the Medicare Administrative Contractor via fax and receive and receive a confirmation acknowledgement in return.
Category A Device – Experimental
- These consist of novel, first-of-a-kind technologies. They are innovative FDA Class III devices for which the absolute risk of the device type has not been established and initial questions of safety and effectiveness have not been resolved. The FDA is unsure whether these device types can be safe and effective.
- Medicare covers the routine costs of clinical trials involving IDE Category A devices effective for routine costs incurred on or after Jan. 1, 2005.
- This extension of coverage only refers to the routine services performed for such a trial. The Category A device itself remains non-covered.
- See details on the Novitas website under Clinical Trials and Devices.
Category B Device – Non-Experimental/Investigational
- These devices are the newer generations of proven technologies that may be in FDA Class I, II or III. Initial questions of safety and effectiveness of these devices have been resolved, and the incremental risk of this device, generally an update to an existing device, is the primary risk in question.
- Medicare covers the routine costs of clinical trials involving IDE Category B devices effective for routine costs incurred on or after Jan. 1, 2005.
- Medicare covers Category B devices if they are considered reasonable and necessary, and if all other applicable Medicare coverage requirements are met.
- This policy does not infer that all devices classified in Category B will be covered under Medicare.
Coverage with Evidence Development (CED)
CMS provides for a coverage mechanism, referred to as coverage with evidence development (CED), in order to extend coverage for selected medical procedures, contingent upon the collection of additional data. In general, CED allows for coverage of FDA approved medical technologies and services when improvements in health outcomes have not been conclusively demonstrated. There are two types of CED:
- Coverage with appropriateness determination (CAD): The item or service is covered only when specific data are submitted in addition to claims data to demonstrate that the item or service was provided as specified in the NCD (database/registry).
- Coverage with study participation (CSP): The item or service is covered only after a formal National Coverage Determination request has been initiated and it is provided within a setting in which there is a pre-specified process for gathering additional data, and in which that process provides additional protections and safety measures for beneficiaries, such as those present in certain clinical trials (clinical research studies – expect to see an FDA approval letter with an associated IDE number). Sponsor is not required to show additional approval from CMS because it is already approved under the CED.
Humanitarian Device Exemption (HDE) and Humanitarian Use Device (HUD)
- A humanitarian use device (HUD) is intended to benefit patients in the treatment and diagnosis of diseases or conditions that affect or manifest in less than 4,000 individuals in the United States per year.
- An approved HDE authorizes marketing of the HUD. However, the HUD may only be used after IRB approval has been obtained for the use of the device for the FDA-approved indication.
- The HUD may only be used in facilities that have an IRB and after the IRB has approved the use of the device to treat or diagnose the specific disease.
- Medicare covers HDEs if they are considered reasonable and necessary, and if all other applicable Medicare coverage requirements are fulfilled.
- No prior approval will be provided for these devices even if the patient is a participant in a clinical trial. MAC submission is no longer required. However, appropriate documentation, if requested, supporting the medical necessity of the procedure/device for the beneficiary must be made available upon request.
Following a Pennsylvania Supreme Court decision regarding informed consent and the effect on the research consent process, it was determined that the proper course of action would be the development of an “Affirmation of Consent Required by Pennsylvania Law.”
Communication to Faculty
This communication was provided to faculty from Neal Thomas, MD, MSc, Associate Dean for Clinical Research:
This Affirmation should be used when “administering an experimental medication, using an experimental device or using an approved medication or device in an experimental manner” to meet the requirements of Pennsylvania’s MCARE Act. The Affirmation should be signed by the physician investigator overseeing that particular patient enrollment in the trial, attached to the IRB-approved informed consent for research document and uploaded into the electronic medical record. Physicians performing other procedures in the course of a research protocol requiring informed consent under the MCARE Act should continue to utilize approved forms, such as MR 21.
The Affirmation is being implemented to address a clinical treatment requirement, not a research requirement. As such, its use will not be subject to review of the Human Subjects Protection Office, which is governed by federal law.
Use is only required when patients who are being treated at a Penn State Health facility are given an experimental medication or device, and will serve to confirm that the physician investigator overseeing the administration of the experimental medication or device had a personal discussion of the intervention and allowed adequate time for questions from the research subject or legally authorized representative.
Further questions related to the interpretation of the MCARE Act can be addressed by Nicole Lehman in the Office of General Counsel. Questions related to the operationalization of this Affirmation can be addressed by Dr. Neal Thomas, Associate Dean for Clinical Research.
Form MR1960: Affirmation of Consent for Research
To access the MR1960 form:
- Log in to the Digital Storefront of the Print Shop.
- In the Search Product field at the top of that page, enter MR 1960 (being sure to include the space).
- Click on the form that opens in the window.
- The form can be ordered from the Print Shop; alternately, investigators may click on the “Preview” link and download the form to print individually. Note: It is recommended that investigators who wish to print the form themselves visit the Print Shop Digital Storefront each time and download the file again in order to ensure they are using the most up-to-date version.
The information in this form may be provided to clinical research sponsors and contract research organizations (CRO) should there be questions about the process.
A Certificate of Confidentiality is a document issued by the FDA or NIH that:
- protects researchers and institutions from outside authorities collecting personally identifiable and sensitive information and
- permits researchers and institutions to refuse to disclose identifying information on research subjects in any civil, criminal, administrative, legislative or other proceeding (e.g., under subpoena, court order).
For questions about Certificates of Confidentiality, contact IRB/HSPO.
According to CDERs Division of Scientific Investigations, “records must be stored under conditions that will preserve their integrity, and that sites be able to retrieve and provide prompt access to such records if the FDA requests such records as part of an inspection”.
The Penn State Inactive Records Center was developed to provide such storage at low rates.
For short-term storage of records on-site in Hershey, contact the College of Medicine Clinical Trials Office at email@example.com.
Penn State College of Medicine’s digital systems have not had their compliance validated for electronic signature. When requested to provide assurance, investigators should use this statement:
“All persons granted access to the electronic medical record (eMR) (Cerner Millennium – Connected) undergo training in the operation and proper use of the system and are assigned specific access rights to system functions. Persons with signatory authority in the eMR have verified that their electronic signature is equivalent to their written signature (copy provided upon request). All employees of Penn State Health Milton S. Hershey Medical Center (PSHMSHMC) and College of Medicine have been informed of and have agreed to abide by the standards of the University and PSHMSHMC with respect to privacy, confidentiality, security and dissemination of all electronic records and communications. At the present time we cannot assure that all of our systems are fully compliant with all provisions of 21CFR11.”
If sponsor requires completion of a sponsor-provided checklist, please call Phil Canakis in Research Informatics at 717-531-0003, ext. 284256, for assistance with and completion of the form.
The Investigational Drug Service (IDS) at Penn State Health Milton S. Hershey Medical Center is charged with the control and management of investigational (research) drugs used in clinical (human) research trials throughout the institution.
See information about the Investigational Drug Service Pharmacy on the Pharmacy section of the Infonet (internal access only; Penn State Health ePass login required).
See all Investigational Drug Services policies in the Policy Portal (Penn State Health ePass login required).
For copies of current CV and licensure for Investigational Drug Services staff, contact the Clinical Trials Office.
Monitors must be granted Penn State Health ePass and CareConnect access.
Requesting Access for Monitors/Sponsors
The IT Account Request Form (internal network access only; Penn State Health ePass login required) must be completed and signed by the monitor/sponsor representative prior to account authorization being given. It may take upwards of two weeks for the access request to be processed, so study teams should plan accordingly.
Page 1: Applicant Personal Information
- Complete areas of the Applicant Personal Information section as follows:
- Leave PSHealth User ID/ePass blank.
- For Employee Type, select External Contractor/Vendor.
- For Business Entity, select applicable organizational site.
- For Hiring Department, list the department requesting access.
- For Work Location, list the name of department requesting access and location where
monitor/sponsor representative will be working from (e.g. Clinical Trials Office, SSB Room 200L).
- For Arrival Date, provide the anticipated date of the first monitoring visit.
- Provide responses to two security questions.
Page 1: Applicant Status Change
- Leave Request Type and Effective Date blank.
- Note that whoever signs in the Manager/Supervisor/Chair role will be the individual who will receive account-related email, such as notification that the account access request has been completed and any additional questions about access.
Page 1: CareConnect Access
- Complete the Application/Network Access section on Page 1
- Under Application, CareConnect (formerly PowerChart), select/check “Add” in the “Position” row.
- Select “No” for secondary account and select “Research External Reviewer” from the options in the “Position” row.
Final Addendum Page: User Access Agreement
- Instruct the monitor/sponsor representative to review and sign the final Addendum page: User Access Agreement.
- Note that per the third item, the monitor/sponsor must complete HIPAA, Privacy and Information Protection training using the substitute training process.
- Complete Applicant Name fields at the top of pages 2 and 3.
Completing the Request Form
- Send all pages of the IT Account Request Form to the monitor/sponsor representative.
- Make sure they complete the form as noted above and sign on the final page.
- Have the individual send back all pages.
- Collect the original signature when the monitor/sponsor representative arrives on site to monitor for the first time.
Currently, account authorization will be audited approximately every three months. The person listed as the Manager/Supervisor/Chair on the form will receive a call from IT Account Management, who will verify that the individual still needs access, the anticipated date of completion, etc. Account Management will also be auditing records to be sure the individual accessed only the records they were supposed to.
There is monitoring space available in the Clinical Research Services area at the Support Services Building.
Email Terry Novchich at firstname.lastname@example.org to inquire about reserving space. It is never a good idea to have monitors working in study team workspaces or in open spaces throughout the institution.
A document describing monitoring guidelines is available to provide to monitors. Download the document from Box (Penn State Access ID login required).
The following documents are the most current on file and may be used in regulatory site files as required by the sponsor.
For copies of the current CV and license for the Clinical Laboratory director, Special Hematology Laboratory director and Investigational Drug Services staff, email CTO@pennstatehealth.psu.edu.