Neuroscience Institute

Research and Grants

Clinical Research Office

The mission of the Clinical Research Office is to provide investigators with the support needed to successfully conduct clinical research.

Micaiah Grien, left, and Heidi Runk, wearing white labcoats and looking at a computer at the Neuroscience Institute

Dedication

The Clinical Research Office is dedicated to the coordination and management of human subjects research for the Penn State Neuroscience Institute, presently managing more than 90 investigator-initiated and industry-sponsored clinical research projects for the Departments of Neurology, Neurosurgery, and Neural and Behavioral Sciences. The office is staffed with 11 clinical research coordinators and two compliance specialists who are responsible for overseeing the day-to-day activities such as regulatory document preparation, patient recruitment, and data collection and documentation associated with the research project. Research projects are organized by disease type and assigned to specific coordinators experienced in each disease management area.

Shubekshya Upadhyay with Penn State Neuroscience Institute works with samples wearing a white lab coat

Research Administration

The Clinical Research Office’s compliance team helps investigators initiate studies within Penn State College of Medicine. The team provides support such as: shepherding contract documents through the Office of Research Affairs, budget review and document processing including data use agreements, non-disclosure or confidentiality agreements with industry sponsored clinical trials and material transfer requests.

Consultations are offered for clinical trial-related research questions and guidance. For example, the team can provide guidance on information needed to submit to the Internal Review Board, as well as guidance on research administration and the process for initiating a clinical trial at the College of Medicine.

Initial Study Intake Form

Contacts for Research Support Assistance

Contact Rachel Myers, rmyers12@pennstatehealth.psu.edu, or Joy Verner, jverner@pennstatehealth.psu.edu, for research support assistance.

A coordinator at the Neuroscience Institute sits at a desk working on a computer

Research Coordination

The Clinical Research Office provides clinical research coordination services for clinical trials within the Penn State Neuroscience Institute.

The team of experienced staff provides support in all aspects of trial related research needs, including:

Recruiting and consenting patients
Scheduling and conducting study visits and related assessments
Data collection and maintenance of study records
Managing regulatory components of studies, including submitting to IRB for continuing reviews and study modifications, and managing monitoring visits from sponsors
Coordination of study needs with clinical care team and principal investigator

A lab technician operates a machine in the Neuroscience Institute lab

Core Areas of Expertise

Cerebrovascular: With a portfolio of studies focused on cerebrovascular disease within the Departments of Neurology and Neurosurgery, research coordinators focus on trials which impact those with stroke, acute brain bleeds and other neurological conditions like Epilepsy.

Neuro-Oncology: With a portfolio of work that supports newly diagnosed and recurring brain cancers for the Departments of Neurology and Neurosurgery, this team is dedicated to supporting cutting-edge clinical trial research, and has expertise in both drug and device related studies.

Neuromuscular: The amyotrophic lateral sclerosis (ALS) clinical trials are organized within three categories: Treatment trials of medications, the use of technology, improving the understanding of ALS.

Data Management

Penn State Neuroscience Institute Clinical Research Office research data manager is responsible for the development and maintenance of research databases using a common data dictionary for all projects, as well as ongoing data monitoring and quality assurance. REDCap (Research Electronic Data Capture) is a secure, web-based application designed to support data capture for human subject research studies. The REDCap application allows users to build and manage online surveys and databases quickly and securely. Examples of databases developed include projects which support studies which support patient and physician surveys, data collection for registries ( specimen and clinical data), and interventional clinical trial studies.

Biorepository

The Penn State Neurosciences Biorepository at the College of Medicine, Milton S. Hershey Medical Center is an integrated specimen (tissue, blood, spinal fluid and buccal swab) bank and clinical database. The purpose is to facilitate basic science, clinical research and translational studies by providing researchers with the ability to obtain and study human specimens using a dynamic collection, storage, annotation, and distribution service. Relevant associated demographic, clinical and outcome data are stored in a REDCapTM database. Four distinct types of biological samples are collected on diverse patient populations under neurosurgery, neuro-oncology, and neurology care: tissue (brain tumors, epilepsy brain tissue, peripheral nerve tumors, spine tumors, vascular tissue, plaque, etc.), cerebral spinal fluid (CSF), blood (whole, plasma, serum, buffy coat) and buccal swab samples.

Biorepository specimens are available for use by investigators through a specific protocol approval process. Samples and data are released in a de-identified manner. The Biorepository is staffed by a Biorepository specialist and a data manager.

A scientist reaches for a sample on the shelf while preparing a centrifuge in the Neuroscience Institute lab

Request more information

If you would like to request more information or request samples for distribution, please submit this form.

Please use the following language to credit the PSNI Biorepository in publications or presentations:

“We would like to acknowledge The Penn State Neuroscience Institute Biorepository for providing the biospecimens used in this study. The biorepository, supported by the Penn State Neuroscience Institute in Hershey, facilitated the collection, storage, and distribution of human biological samples and associated data, which were critical to the success of this research.”

Neuroscience Institute Biorepository Request Form

Pre-Award

The Neuroscience Institute pre-award team currently consists of a grants and contracts manager and two pre-award specialists. This team provides pre-award support for the departments of Neurology, Neurosurgery and Physical Medicine and Rehabilitation. Specifically, the team works closely with faculty members on their grant applications, annual progress reports, Just in Time requests and other grants-related matters. The pre-award team is designed to provide cross-coverage service to investigators, ensuring seamless work when one or more team members are out of the office to ensure work flow is never interrupted for our investigators. Since 2017, the Neuroscience pre-award team has submitted 540 external grant applications (nearly $122 million) and activated 294 funded awards (more than $51 million). The team is dedicated to providing superb service to investigators so they can focus on their research.