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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.
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Working with STAR
A STAR submission is required for:
- Any clinical research study where it is possible for items and services to be captured in the hospital billing system and potentially by billable to a study sponsor, a third-party payer and/or the participant. (This includes, but is not limited to, investigator-initiated/sponsored research studies funded by departmental monies, the federal government, non-profit or for-profit entities.)
- Any clinical research study in which there will be invoices generated to a sponsor/funding agency for services provided.
A STAR submission is optional for non-billable/non-invoiceable clinical studies for which the research team may choose to use the STAR system for study participant and financial tracking functionality.
Optional studies may include:
- Chart reviews
- Survey studies
- Educational/training studies
- Biospecimen collection/analysis
- Interview procedures or focus groups
- Data collection/data analysis
- Patient registry
- Long-term follow-up
- Observational studies
An Information Technology Account Request Form, available on the Infonet (Penn State Health ePass login required), must be completed to access STAR.
On the first page of the form, the new STAR user is required to provide name and Penn State Health ePass user ID (such as ychen or jsmith). The user’s manager must provide their printed name, ePass user ID, date and signature.
The STAR-specific portion of the form can be found near the top of page 3. Click/check the “Add” column, enter Penn State Access ID (such as yxc000 or jls000) and select the designated STAR role from the drop-down menu. Study team members should select “Study Staff,” ancillary reviewers should select the appropriate ancillary group, etc. Those who need more than one role will need to submit additional forms. Potential users who are uncertain of the appropriate role should contact the STAR Team.
Once completed and signed, the form should be sent to STAR@pennstatehealth.psu.edu for approval. The STAR Team will then forward the form to Accounts Management, who will contact the new user directly once the account has been created or with questions.
More about STAR
As a clinical research management system, STAR connects and empowers teams with 24/7 online access to study, budget, participant and visit information. STAR replaces time-consuming paper processes, facilitates communication, eliminates redundant steps that burden both researchers and administrators and reduces compliance risk exposure.
The backbone of STAR is its skillful tracking of study participants and intelligent management of invoices for all the visit procedures performed.
Key advantages of STAR include:
- Facilitating study form submission to the Clinical Trials Office and Office of Research Affairs
- Generating automated email notifications to support communication and inform the research team of key status changes
- Reducing multiple, isolated, informal environments for managing and tracking study data
- Tracking established research participants throughout their course of treatment/participation
- Improving cost recovery through timely and complete sponsor billing and collections
Because STAR is part of CATS IRB, it will be automatically populated with some of the information already entered into IRB. An IRB submission does not need to be completed/approved to begin a STAR submission. STAR studies will display a direct link to their IRB counterpart and vice versa. To avoid duplication, some documents (such as the protocol, informed consent forms and investigator’s brochure) reside only in CATS IRB, while others reside in STAR.
Note that Internal Approval Forms (IAFs) are part of the Strategic Information Management System (SIMS), which is associated with University Park. IAFs are unrelated to STAR and, at the present time, the systems are not integrated.
STAR is a secure system. All those who access STAR must do so using their Penn State Access ID. Once
in STAR, users will only see studies to which they are specifically assigned. In addition, access to view
and/or edit information is strictly controlled based on user role (study team, ORA, financial contact,
ancillary reviewer, etc.).
STAR requires patient names in order to create invoices, bill sponsors, pay stipends, etc. Like any system that stores HIPAA data such as patient name, STAR is regularly scanned for vulnerabilities, as are all systems in IT’s data center.
- Reporting: The reporting feature of STAR is under construction. As STAR matures, the STAR team will begin creating reports based on the needs and requests of those who are using the system.
- Other integrations: STAR does not yet have an integrated solution to support the enterprise-wide needs of those conducting clinical research. It is presently unable to integrate with existing EMR, financial and grants/contracts systems.
Users who wish to submit a suggestion for future STAR enhancements or training sessions should complete the online suggestion form.
All research studies that require a STAR submission will be initiated by the study team as part of the IRB submission process. STAR offers hands-on training sessions for all those who will be using the system.
STAR training sessions are available on Tuesday and Thursday mornings. Anyone who needs new user or refresher training should email STAR@pennstatehealth.psu.edu with preferred date and time.
Before submission of their first research study into STAR, study team members should complete the following two hands-on training sessions with the STAR team:
Getting STAR-ted, an Introduction to STAR
This one-hour session covers the following topics:
- What is STAR?
- What studies require a STAR submission?
- Benefits of STAR
- Tour of STAR
- Uploading documents
Creating/Submitting a New Study in STAR
This one-hour session covers the following topics:
- STAR submission through IRB
- Editing a study
- Submitting a study
- Centralized communication
Once a study is “Active” in STAR and the study team has at least one participant to enter into the system, new users should contact the STAR Team to arrange the following training session:
Participant Tracking in STAR
This one-and-a-half-hour session covers the following topics:
- Entering new participants
- Consenting, recording eligibility and placing participants on study
- Completing visits
- Logging invoiceable events