Department of Public Health Sciences

Research Computing

Research Computing develops and supports Information Technology solutions for the research and educational missions as well as the operational requirements of the Department of Public Health Sciences.

The unit consists of two groups of information technology professionals: a networking and systems administration group and an applications development team.

Collectively, the Research Computing teams provide IT infrastructure and support services for the Department's Data Coordinating Center activities for large multi-center clinical trials funded by the National Institutes of Health (NIH).

Networking and Systems Administration

The network and systems administration team maintains the Department of Public Health Sciences IT infrastructure and on-site data center while also fulfilling a national network role that resides within the Data Coordinating Center function of the Department. In addition, the group provides helpdesk support to faculty and staff within the Department and to personnel within the Clinical Research Center.

Secured Collaborative Research: The network and systems administration team supports a Citrix research environment that encapsulates and secures all collaborative research and has the ability to apply security configurations tailored to the specific requirements of a given study and data provider. In each instance, the Citrix session will be captive, meaning no data can be copied externally from electronic storage or from within a software application hosted by the secured Citrix environment. Most software packages used within the department can be published and launched through Citrix. However, the software and data displayed on the menu is based on the permissions and access level of each researcher.

Application Development

The applications development team designs and authors specialized, custom database-driven applications to collect clinical trial information and provide numerous services to meet the needs of a variety of clients. The group has experience in application and database development on multiple platforms and will work with groups or individuals to design and deploy a database application suitable for the customer's needs.

Services include:

• Meeting with clients to analyze requirements for an application.
• Designing, developing and testing high-quality software solutions.
• Performing risk analysis and adhering to security requirements.
• Providing training and support to end users.
• Monitoring and tuning applications to achieve high-performing solutions.

Featured applications include:

• Clinical Trials Application: Our custom-built Clinical Trials Application (CTA) is a secure, robust, web-based application used for clinical research studies. It is composed of multiple, customizable modules that perform specific functions related to electronic capture of participant data and biospecimens, clinical data management activities, and clinical trial management.
• REDCap Interfacing: Our applications development team is experienced with scheduling jobs that automatically interface with the REDCap application to push or pull data to supplement REDCap functionality.

Contact Us

For more information about systems administration, contact Steve Brown at steve.brown@psu.edu or 717-531-4246.

For more information about application development, contact Aimee Merchlinski at amerchlinski@pennstatehealth.psu.edu or 717-531-4122.

Data Management

The Data Management unit within the Department of Public Health Sciences consists of a group of professionals specializing in the collection, processing and management of clinical research data.

The Data Management team collaborates with investigators and their research staff in evaluating the data management needs of their projects and proposing data management procedures and software solutions tailored to their needs.

Why work with Data Management?

• The Institutional Review Board (IRB) and Research Quality Assurance (RQA) at Penn State College of Medicine require clinical trial monitoring for investigational drug/devices (IND/IDE), multisite and high-risk clinical trials.
• The Public Health Sciences (PHS) Data Management Unit receives institutional support to provide free clinical trial monitoring services to Penn State investigators conducting clinical research.
• Additionally, the Data Management team can prepare budget estimates for other types of human subject research in need of data monitoring services.

The Value of Clinical Trial Monitoring

Clinical Trial Monitoring services provided by Data Management help the investigator ensure that:

• All clinical trial activities follow the research protocol
• Participants’ rights, welfare and safety are protected
• Quality, reliability and integrity of data collected are maintained throughout the study
• Liability risk to the institution is minimized

Clinical Trial Development Support

The Data Management team facilitates the implementation of studies by:

• Reviewing the integrity of Case Report Forms, REDCap form design, data management plan and randomization procedures
• Preparing regulatory binders for studies
• Ensuring compliance with informed consent documentation policy and procedures
• Customizing a clinical trial monitoring plan to meet the needs of the study
• Securing approval of the clinical trial monitoring plan with external sites

Customized Data Monitoring Plans

The Data Management team develops plans based on:

• Complexity of the study design
• Level of risk associated with the study
• Type of study endpoints
• Type of data capture
• Number of study sites
• Stage of the study

Clinical Trial Monitoring Visits

Clinical trial monitoring visits are an essential part of the monitoring services and allow the Data Management team to:

• Ensure sites' adherence to protocol
• Review presence of essential documents in regulatory binder
• Verify consistency between electronic database and source documents
• Track and account for investigational products
• Assess participant safety measures

Contact Us

For more information about Data Management, contact Paula Valencia-Moulton at pmoulton@pennstatehealth.psu.edu or 717-531-7689.

Download the Clinical Trial Monitoring brochure

Consulting

Faculty and professional staff in the Department of Public Health Sciences offer collaboration and consultation in biostatistics, epidemiology, and health services research to researchers and students. Collaboration and consultation may include, but are not limited to:

• Design and analysis strategies for research proposals.
• Sample size and power calculations for research proposals.
• Advice on the selection and implementation of appropriate statistical methods for research data.
• Statistical analysis and graphical analysis of research data.
• Statistical reviews of grant proposals, protocols, and manuscripts.

Funding

Funding is not required for grant or contract proposals where PHS personnel will be written into the proposal for future funding. To receive proper attention, requests should be received well ahead of the submission deadline.

Limited un-funded consultation is provided for medical students working on their Medical Student Research projects. Generally, a few hours is provided free of charge for MSR projects.

For further information, medical students should view the MSR guidelines.

Hands-on assistance with data analysis is generally not provided without funding.

Contact Us

To being the consulting process, please complete and submit the Biostatistics and Bioinformatics, Epidemiology, and Health Services Research Collaboration Request Form.

The information collected on this form will enable PHS to best meet your projects goals. Within two business days of receiving your Request Form, the PHS faculty or staff member handling your project will contact you to schedule an appointment.

In cases of emergency, and subject to the availability of personnel, PHS can provide limited assistance on short notice.

Project Management

The Department of Public Health Sciences has an established pool of project managers and research assistants with expertise in the operational aspect of both administrative management and clinical implementation of trials.

Administrative Trial Management

Our project managers focus on ensuring that effective project plans are in place and operational for each trial, working with stakeholders to establish priorities in accordance with applicable project plans, standard operating procedures, ICH/GCP guidelines and regulatory requirements.

Project managers translate project planning and design decisions into concrete activities and tasks, which involves:

• developing and continually updating the timetable for all tasks required for data coordination
• coordinating project staffing and the assignment of specific tasks to personnel
• monitoring project progress and ensuring that necessary tasks are completed on schedule

Project managers also assist in determining and securing medications, supplies and equipment to meet trial requirements.

Areas of expertise include:

• negotiating sourcing with vendors
• calculating medication quantities
• overseeing the blinding, labeling and packaging of study medication
• coordinating the distribution and storage of study medication, equipment and supplies
• sourcing central laboratories to process and analyze biological samples
• ensuring regulatory documents are in place to meet compliance

Project managers promote collaboration among researchers through the organization of meetings and teleconferences and remain active throughout a trial to ensure its successful completion.

Clinical Trial Implementation

Our Project Managers are trained and have expertise in operationalizing clinical trial protocols including processes for overall study process, concept, and design.

Although the Principal Investigator is legally responsible for all aspects of the research study, the project manager handles the bulk of the daily study activities and plays a key role in the study conduct and management.

Project managers are responsible for organizing the documentation and files pertaining to a study and for coordinating the activities of the investigators/research personnel and study participants. Project managers can serve as the communication liaison between Principle Investigators and internal/external entities. They can oversee research staff and processes at the local institution and at external clinical sites, providing training and troubleshooting as needed.

Our project managers and research assistants have expertise in full life-cycle clinical trial implementation from start-up, including protocol development, obtaining IRB and other regulatory approvals to participant recruitment, screening, and completing data collection. This includes experience with managing participant visit scheduling, collecting basic clinical measurements, administering questionnaires, and assessing and reporting adverse events.

In addition, our project managers can coordinate on the development of research databases and generate reports to track trial progress such as monitoring participant accrual, dropouts and compliance.

Contact Us

For details on project management, contact Justin Cowan at jcowan@pennstatehealth.psu.edu or 717-531-5550.